NEWS
April, 2024 News
FDA grants breakthrough device designation for Roche Diagnostics blood-based p-Tau 217 test in Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation Roche Diagnostics’ Elecsys pTau217 assay, which searches for and quantifies phosphorylated fragments of the brain protein tau, with the goal of capturing a biomarker that can distinguish Alzheimer’s from other neurodegenerative disorders. This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer’s disease on people and society. Breakthrough device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved. In 2022, FDA granted breakthrough designation for a separate Alzheimer’s-focused blood test—aimed at the proteins pTau-181 and apolipoprotein e4 (ApoE4)—and has secured agency approvals for two pairs of Elecsys in vitro diagnostics that analyze CSF for amyloid and tau. For additional perspective, click here.
NIA releases new AD/ADRD care research implementation milestones
The National Institute on Aging (NIA) has released eight new Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) Care and Caregiving Research Implementation Milestones. The new milestones cover:
- Outcomes that Matter
- Comprehensive Care Models
- Health IT Consequences and Disparities
- Identifying Care Partners
- Caregiver Resilience and Wellbeing
- Community-Engaged Research
- Workforce Impact on Outcomes
- Healthcare Decision Making
Visit the 2023 Dementia Care and Caregiving Research Summit website for the full milestones and success criteria. The new milestones are informed by input from the research community and broader public to enhance NIA’s programs in AD/ADRD science, including the research gaps and opportunities from the 2023 Dementia Care and Caregiving Summit. The scientific areas encompassed in these new milestones reflect research priorities of importance to multiple stakeholder communities and hold promise for advancing research that is relevant to real world practice. The new milestones will be incorporated into the AD/ADRD Research Implementation Milestone Database in Summer 2024.
CMS issues 2025 Medicare Advantage and Part D final rule
The Centers for Medicare & Medicaid Services (CMS) has issued its final rule revising the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program (Medicare Part D), Medicare Cost Plan Program, Programs of All-Inclusive Care for the Elderly (PACE), and Health Information Technology Standards and Implementation Specifications. The final rule includes provisions addressing integrated care, including replacing Medicare’s current quarterly special enrollment period (SEP) with a one-time-per-month SEP for dually eligible individuals and those enrolled in the Part D low-income subsidy program to elect a standalone PDP; creating a new monthly Medicare integrated care SEP to facilitate aligned enrollment for full-benefit dually eligible individuals; limiting the number of dual eligible special needs plans; and, redefining broker and agent compensation, among others. The regulations take effect on June 3. Read the CMS summary.
USAging launches the National Caregiver Champion Collaborative
USAging recently launched the National Caregiver Champion Collaborative (CCC), which facilitates and supports peer networking and engagement for Aging Network providers and partners leading caregiving services and supports. CCC participants will gather regularly in an affinity group model to share successful strategies and best practices, discuss lessons learned, explore new partnerships, and get insight into the latest research and emerging evidence-based programs. Champions will be encouraged to develop ongoing state, regional, or local caregiver efforts focused on enhancing and innovating caregiver services and supports. This effort is administered by USAging through the Innovations in Family Caregiver Services and Supports cooperative agreement from the U.S. Administration for Community Living (ACL). Participants are likely to be leaders and managers from Aging Network providers and partner organizations, such as State Units on Aging, Area Agencies on Aging/Title VI Programs, aging service providers, caregiving service providers, and others. To apply to join the CCC, click here.
Issue brief addresses guardianship data deficit
A new issue brief by Justice in Aging highlights the deficit in data regarding guardianship in the United States and analyzes resulting challenges to reforming the guardianship system. The brief addresses the need for data to understand who is under guardianship, why they are under guardianship, and the risks marginalized older adults face but which may go unreported. The issue brief includes current data reform efforts and recommendations to advance equity in guardianship.
Additional Reads
- Endothelial DR6 in blood-brain barrier malfunction in Alzheimer’s disease (read here)
- A lipidome landscape of aging in mice (read here)
- Easing Microglial Brakes Alleviates Amyloid Pathology in Mice (read here)
- Setting up a power of attorney for a parent with dementia could help you avoid a costly and messy guardianship proceeding. Here’s how to do it (read here)
- Impact of genetic predisposition to late-onset neurodegenerative diseases on early life outcomes and brain structure (read here)
- P-tau217 Immunotherapy Alleviates Tangle Pathology in Mice (read here)
- Giving primary-care docs training, tools to manage dementia (read here)
- Remini-Sing RCT: Therapeutic Choir Participation for Community-Dwelling People with Dementia and Their Primary Caregivers (read here)
- How the Inflamed Brain Becomes Disconnected After A Stroke (read here)
- Bridging Health Disparities With Culturally Competent Technology (read here)
- Multisensory flicker modulates widespread brain networks and reduces interictal epileptiform discharges (read here)
- Heart Rate Variability: A Possible Marker for Agitation in Alzheimer’s Disease (read here)
- Improving dementia care in nursing homes: Learning from the pandemic years (read here)
- Study Suggests Racial Discrimination During Midlife Associated with Alzheimer’s Disease Pathology Later in Life (read here)
- How your vision can predict dementia 12 years before it is diagnosed – new study (read here)
- Predictors for survival in patients with Alzheimer’s disease: a large comprehensive meta-analysis (read here)
- Multiple Strategies Seek to Banish α-Synuclein Aggregates (read here)
- Newly Found Genetic Variant Defends Against Alzheimer’s Disease (read here)
- Cognitive decline may be detected using network analysis, according to Concordia researchers (read here)
- Understanding the Complexity of Early-Onset Dementia (read here)
- Medicare can follow blazed trails to revitalize Alzheimer’s care (read here)
- Five biomarkers from one cerebrospinal fluid sample to stage Alzheimer’s disease (read here)
- Dementia’s next test: New Alzheimer’s diagnostics are coming (read here)
- Insurers Could Deny Coverage to People With Alzheimer’s Risk Genes (read here)
- The concept of resilience to Alzheimer’s Disease: current definitions and cellular and molecular mechanisms (read here)
- Fueling nerve cell function and plasticity (read here)
- New study highlights the benefit of touch on mental and physical health (read here)
- AHEAD study tests prevention of Alzheimer’s disease in asymptomatic people who are at risk (read here)
- Tau pathology is associated with synaptic density and longitudinal synaptic loss in Alzheimer’s disease (read here)
- New Study Shows Air Pollution Increases Risk of Developing Alzheimer’s Disease (read here)
- What kids can learn from a relative with dementia (read here)
- Can prior musical experience benefit frontotemporal dementia patients? (read here)
- Human Neuron Model Paves the Way for New Alzheimer’s Therapies (read here)
- Impact of the COVID-19 pandemic on mortality and loss to follow-up among patients with dementia receiving anti-dementia medications (read here)
- Inpatient Delirium Is Associated with Future Dementia (read here)
- Disruption of a molecular pathway may be involved in Alzheimer’s (read here)
- Immunotherapy for Alzheimer’s disease shows promise in mouse study (read here)
- Researchers uncover a potential method for interrupting the misfolding of tau protein that underlies neurodegenerative disease (read here)
- No replication of Alzheimer’s disease genetics as a moderator of the association between combat exposure and PTSD risk in 138,592 combat veterans (read here)
- Blended Antioxidant Supplement Improves Cognition and Memory in Aged Mice (read here)
- Organoids reveal how to protect the brain against dementia and ALS following traumatic injury, according to USC Stem Cell study (read here)
- Stressful events in midlife might be a risk factor for Alzheimer’s disease in older ages (read here)
- Predicting cognitive function and dementia risk in patients with hypertension (read here)
- Personalized Model Unveils Hidden Patterns in Alzheimer’s Progression (read here)
- Ultrasound therapy shows promise as a treatment for Alzheimer’s disease (read here)
- Skin Deep: Punch Biopsies Detect Synucleinopathies (read here)
- Hospice care for those with dementia falls far short of meeting people’s needs at the end of life (read here)
- App May Pave Way to Treatments for No. 1 Dementia in Under-60s (read here)
- Well-being could be the path to improved dementia prevention and care: report (read here
- GSU Study Examines Perceptions of Benefits and Risks of Data Sharing in Dementia Research (read here)
March, 2024 News
FY 2024 federal appropriations avert catastrophic proposed cuts and deliver progress on some dementia priorities
The recently completed Fiscal Year 2024 (FY 2024) congressional appropriations process averted catastrophic funding cuts that some in Congress had been pursuing since last year. Thanks to advocacy from the LEAD Coalition community, other stakeholder organizations, grassroots activists across the country, and the courageous leadership from our bipartisan congressional allies, vital work will be maintained and expanded by federal agencies to accelerate science and improve quality of life among people living with dementia and their carers. NIH’s overall funding will be increased by $300 million to $48.6 billion and Alzheimer’s/dementia research funding will be increased by $100 million to over $3.8 billion annually (NIH invested $631 million in dementia research in FY 2015).
A number of Administration for Community Living (ACL) aging services and support programs important to the dementia community also will receive level funding in FY 2024, including the Alzheimer’s Disease Demonstrations program, the Lifespan Respite Care program, the Elder Falls Prevention program, and the Home and Community-based Services (HCBS) program. Two bright spots are increases of $25 million for the Congregate Meals program and $15 million for the Home Delivered Meals program. For additional details, see the National Council on Aging (NCOA) aging programs funding table.
The appropriations package increases CDC’s resources for its public health approach to brain health and dementia with $34 million to continue implementation of the BOLD Infrastructure for Alzheimer’s Act. FDA funding is roughly level, including $2 million to continue the Neurology Drug Program, which focuses on policy and guidance that keeps pace with scientific discovery in neuroscience, to advance the prevention and early detection of brain conditions.
For full details on the two minibus appropriations packages, click here and here and scroll toward the bottom of the page for individual agencies’ summaries.
Alzheimer’s Association publishes annual Facts and Figures report and special report on care navigation
The Alzheimer’s Association hasreleased its 2024 Alzheimer’s Disease Facts and Figures report, providing an in-depth look at the latest national statistics on Alzheimer’s incidence, prevalence, mortality, costs of care, and impact on caregivers. The accompanying special report, Mapping a Better Future for Dementia Care Navigation, provides a comprehensive look into dementia care navigation, revealing significant insights into the experiences and challenges faced by caregivers and health care workers in helping people living with Alzheimer’s or other dementia navigate the health care system. For highlighted national data, read the Executive Summary. For state-by-state data one-pagers, click here.
BOLD Center on dementia detection publishes health systems toolkit
The BOLD Public Health Center of Excellence on Early Detection of Dementia, in collaboration with the CDC, has published a new toolkit resource for clinicians, administrators, and patients engaged with large health systems who are interested in promoting early detection of dementia, establishing supportive services, and becoming more dementia capable. The toolkit supports a comprehensive approach to dementia detection and includes resources that encompass a broad view of the capacities needed to make your efforts most effective and cultivate a supportive and sustainable care pathway for individuals and their families.
FDA grants breakthrough device designation for Quanterix blood-based p-Tau 217 test in Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for Quanterix Corporation’s Simoa® phospho-Tau 217 (p-Tau 217) blood test as an aid in diagnostic evaluation of Alzheimer’s disease. The test described in the is a semi-quantitative in vitro diagnostic immunoassay for measurement of p-Tau 217 concentration in plasma of patients presenting with cognitive impairment. The test is not intended as a stand-alone diagnostic test and test results will be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis. Breakthrough device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved. For additional information, click here.
ACL publishes resource on fostering social connections for people living with dementia
The Administration for Community Living’s (ACL) Commit to Connect (CTC) initiative has published a resource to support social connections for people living with dementia. This guide highlights easily replicable programs such as memory cafes and art or music-focused activities, providing practical examples for enhancing social engagement. In addition, it provides valuable communication tips for interacting with people living with dementia and encourages active participation in the CTC Nationwide Network of Champions.
Study highlights support reciprocity in early-stage dementia
Research led by the University of California, Davis, suggests that people living with early stage dementia can support their care partners, and that reciprocated care has mutual benefits. The study highlights that couples coping with dementia can navigate the challenges with greater resilience and well-being by working together and supporting each other. Researchers surveyed 72 couples in which one person was living with early-stage Alzheimer’s disease and their spouse was the primary care partner. The study assessed the support that spouses provided to each other and found that people with dementia often assisted their spousal care partners. Researchers found that the support given by people living with dementia occurred in various ways, like practical help including folding the laundry, dishwashing and cooking. The most common type of support was emotional, including showing appreciation and care.
17 novel genetic variants associated with Alzheimer’s disease
A new study, led by the Boston University School of Public Health and the UTHealth Houston School of Public Health, utilized whole genome sequencing to identify 17 genetic variants associated with Alzheimer’s disease in five genomic regions. researchers conducted single-variant association analyses and rare-variant aggregation association tests using whole genome sequencing data from the Alzheimer’s Disease Sequencing Project (ADSP), a genetics initiative that the National Institutes of Health developed in 2012 as part of the National Alzheimer’s Project Act’s goal to treat and prevent the disease. The ADSP data include more than 95 million variants among 4,567 participants with or without the disease. Among the 17 significant variants that were linked to Alzheimer’s disease, the KAT8 variant was one of the most notable, as it was associated with the disease in both the single- and rare-variant analyses. The researchers also found associations with several rare TREM2 variants. The ADSP includes ethnically diverse participants, and the population-specific assessments focused on White/European-ancestry, Black/African-American, and Hispanic/Latino subgroups, as well as a multi-population meta-analysis. Historically, Black and and Latino populations have been underrepresented in genetic studies of Alzheimer’s disease despite having a higher prevalence of the disease than other ethnic groups.
Additional Reads
- Primary care physicians should be at the heart of treating Alzheimer’s (read here)
- Does Long-Term Benadryl Use Increase Dementia Risk? (read here)
- Risk factors for faster aging in the brain revealed in new study (read here)
- Common degenerative brain disease may begin to develop already in middle age (read here)
- From Autism to Alzheimer’s: A Large-Scale Animal Study Links Brain pH Changes to Wide-Ranging Cognitive Issues (read here)
- New treatment target identified for Alzheimer’s disease (read here)
- Human brains are getting larger. That may be good news for dementia risk (read here)
- AI brain scans detect early Alzheimer’s with 90% success (read here)
- CSF Hugs Arteries to Squeeze into the Brain (read here)
- Study finds high prevalence of hidden brain changes in people with heart disease (read here)
- Improving Trends in Brain Health Explain Declining Dementia Risk? (read here)
- Blurred Vision and Hallucinations: The First Signs of a Rare Form of Alzheimer’s (read here)
- At-Home Tools to Diagnose Alzheimer’s, Parkinson’s, and Related Diseases (read here)
- We created a VR tool to test brain function. It could one day help diagnose dementia (read here)
- Plasma p-tau212 antemortem diagnostic performance and prediction of autopsy verification of Alzheimer’s disease neuropathology (read here)
- Study: Newly Discovered Beneficial Mutation in Mitochondrial DNA Appears to Help Alzheimer’s Gene Carriers Live Longer, Stay Sharper and Represents a New Direction in Drug Discovery (read here)
- How might diabetes lead to Alzheimer’s? Study suggests the liver is key (read here)
- Therapeutic Contenders Target Hard-to-Reach Pockets of Tau (read here)
- ‘The story of being a burden has been told too many times’: how dementia-friendly theatre is changing the narrative (read here)
- Movement disorder ALS and cognitive disorder FTLD show strong molecular overlaps, new study shows (read here)
- The Alzheimer’s disease risk gene BIN1regulates activity-dependent gene expression in human-induced glutamatergic neurons (read here)
- COVID-19 Infection Tied to Slight Cognitive Deficits (read here)
- Researchers Describe Tools to Better Understand CaMKII, a Protein Involved in Brain and Heart Disease (read here)
- TREM1 Muddles Myeloid Cell Metabolism and Memory in Old Mice (read here)
- New studies suggest millions with mild cognitive impairment go undiagnosed, often until it’s too late (read here)
- High-Tech ‘Ear’ Lets Alzheimer’s Caregivers Keep Eye on Emotions (read here)
- Alzheimer’s Disease — Managing Stages of Dementia (read here)
- Disease staging of Alzheimer’s disease using a CSF-based biomarker model (read here)
- Racial and ethnic differences in disease course Medicare expenditures for beneficiaries with dementia (read here)
- Rural and minority dementia patients face disparities in access to neurologists (read here)
- Reverse Electron Flow in Microglia Linked to Neuroinflammation (read here)
- Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies (read here)
- Nighttime vasomotor symptoms linked to Alzheimer’s risk (read here)
- How AI Is Turbocharging Alzheimer’s Brain Scans (read here)
- Alzheimer’s and Parkinson’s biomarkers show promise for early diagnosis (read here)
- The ‘middle-aging’ brain: Trends in Neurosciences (read here)
- An Insertion Within SIRPβ1 Shows a Dual Effect Over Alzheimer’s Disease Cognitive Decline Altering the Microglial Response (read here)
- Genetic overlap between Alzheimer’s disease and immune-mediated diseases: an atlas of shared genetic determinants and biological convergence (read here)
- Active Social Lives Help Dementia Patients, Caregivers Thrive (read here)
- X-Ray Activated Nanoparticles Combat Alzheimer’s Disease (read here)
- Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (read here)
- Hearing loss promotes Alzheimer’s disease (read here)
- Study Shows a Healthy Diet is Linked with a Slower Pace of Aging, Reduced Dementia Risk (read here)
- Scientists create tools to identify patients with potentially treatable forms of rapidly progressive dementia (read here)
- Poor Neighborhoods Linked to Elevated Dementia Risk and Faster Brain Aging (read here)
- Can the BCG vaccine protect against Alzheimer’s disease?(read here)
- Alzheimer’s Drug Fermented With Help From AI and Bacteria Moves Closer to Reality (read here)
- Researchers call for a major rethink of how Alzheimer’s treatments are evaluated (read here)
- Blast-related concussions linked to higher Alzheimer’s risk (read here)
- APOE4/4 is linked to damaging lipid droplets in Alzheimer’s disease microglia (read here)
- Slowed speech may indicate cognitive decline more accurately than forgetting words (read here)
- Predicting early Alzheimer’s with blood biomarkers and clinical features (read here)
- Adapting prescribing criteria for amyloid‐targeted antibodies for adults with Down syndrome (read here)
- Quest Alzheimer’s Blood Test No Longer Marketed Directly to Patients (read here)
- HIV Drug Safe in Alzheimer’s Pilot Trial, Nudged Biomarkers (read here)
- High blood pressure’s impact on white matter could be key to dementia prevention (read here)
- Researchers Identify Gene Involved in Neuronal Vulnerability in Alzheimer’s Disease (read here)
- Wrist Device That Monitors Activity Could Help Provide Early Warning of Alzheimer’s (read here)
- Updates on mouse models of Alzheimer’s disease (read here)
- Dementia Caregiver Experiences: Insights From a Telephone-Based Support Program (read here)
- Study opens the door to earlier diagnosis and potential treatment for Alzheimer’s Disease (read here)
- FDA Delays Decision on Alzheimer’s Hopeful Donanemab (read here)
- AD/PD 2024: the role of blood-based biomarkers in Alzheimer’s disease (read here)
- A New Headset Aims to Treat Alzheimer’s With Light and Sound (read here)
- Single cell transcriptome analysis of the THY-Tau22 mouse model of Alzheimer’s disease reveals sex-dependent dysregulations (read here)
- Alzheimer’s Disease — Anti-Amyloid Medications, Early Detection, and Screening (read here)
- Explainable AI-based Deep-SHAP for mapping the multivariate relationships between regional neuroimaging biomarkers and cognition (read here)
- Sex-specific associations of serum cortisol with brain biomarkers of Alzheimer’s risk (read here)
- Dementia More Common in People With Essential Tremor (read here)
- Neuropathologic Features Affect Dementia Differently Depending on Patient Age (read here)
- BHLHE40/41 regulate microglia and peripheral macrophage responses associated with Alzheimer’s disease and other disorders of lipid-rich tissues (read here)
- When a Loved One with Dementia Spends Excessively (read here)
- Behaviors of Pain During Movement in Elderly with Dementia (read here)
- Machine learning and XAI approaches highlight the strong connection between and pollutants and Alzheimer’s disease (read here)
- Do Sleep Rhythms Create Ion Waves That Rinse the Brain? (read here)
- Earliest-yet Alzheimer’s biomarker found in mouse model could point to new targets (read here)
- UF-led study could lead to new way to detect brain changes associated with Alzheimer’s risk (read here)
- More on Moribund Mitochondrial Respiration Prior to Plaques (read here)
- New Federal Report Highlights Pandemic Lessons for Nursing Homes (read here)
- Commentary: Do you really want to find out if you’ll get Alzheimer’s? (read here)
- Electroencephalography-based classification of Alzheimer’s disease spectrum during computer-based cognitive testing (read here)
- Understanding lucid episodes in dementia (read here)
- Cholinergic changes in Lewy body disease: implications for presentation, progression and subtypes (read here)
- Art on your prescription – a museum, a gallery, maybe some music? (read here)
- Living with memory loss, working to fend off dementia (read here)
- Automated detection of Alzheimer’s disease: a multi-modal approach with 3D MRI and amyloid PET (read here)
- Alzheimer’s Experts Review Progress and Challenges in a ‘Transformative Moment’ (read here)
- Medicare’s New Dementia GUIDE Model: How Can Physicians, Hospices, and Home Health Agencies Participate? (read here)
- Biomarker-based staging of Alzheimer disease: rationale and clinical applications (read here)
- Tau Fragments in Plasma Track with Tangles, Cognitive Decline (read here)
- Tiny magnetic particles in air pollution linked to development of Alzheimer’s (read here)
February, 2024 News
HHS launches initiatives to strengthen direct care workforce
The U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), has announced new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the severe shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. These initiatives include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers:
- DCW Intensive Technical Assistance, which will facilitate collaboration among state agencies – including Medicaid, aging, disability, labor and workforce development systems – and with stakeholders to improve recruitment, retention, training, and professional development of the direct care workforce. It will include a focus on strategies to help states sustain direct care workforce initiatives funded through the American Rescue Plan. The DCW Strategies Center will provide up to 250 hours of individualized technical assistance on a variety of issues for up to six cross-agency state teams. Each team will be assigned a coach and have access to subject matter experts to support them in addressing their state’s unique needs. Each team will include representatives from the state’s Medicaid, aging, disability, and workforce development agencies, in addition to other stakeholders. The support provided through this initiative will be coordinated by a consortium led by ADvancing States, in partnership with the National Association of State Directors of Developmental Disability Services and the National Association of State Medicaid Directors.
- DCW Peer-Learning Collaboratives, which will bring together four to six states in a working group focused on a particular topic. There will be up to three learning collaboratives available to states. The DCW Strategies Center will host monthly virtual meetings focused on group learning to facilitate information sharing on best practices, innovative strategies and demonstrated models for growing the direct care workforce. In addition, each participating state will receive up to 70 hours of individual technical assistance on a topic or issue important to the state. Each participating state will be expected to accomplish one policy or program-related milestone within the parameters of the topic of focus as a result of participation in one of the collaboratives.
These initiatives will help sustain the impact of the $37 billion in American Rescue Plan funding invested to date by states in home and community-based services, and support the comprehensive set of actions and investments included in the President’s executive order to improve care.
On March 8, the DCW Strategies Center will host an informational call to provide more information about these technical assistance opportunities. Advance registration is required. Complete details about these opportunities, including application instructions, also can be found in the call for applications. On March 7, the DCW Strategies Center will kick off a technical assistance webinar series addressing a variety of topics related to strengthening and supporting the direct care workforce.
ACL issues updated regulations for Older Americans Act programs
The Administration for Community Living (ACL) has released a final rule updating regulations for implementing Older Americans Act (OAA) programs. The first substantial update to most OAA program regulations since 1988, the rule aligns regulations to the current statute, addresses issues that have emerged since the last update and clarifies a number of requirements. The final rule seeks to better support the national aging network that delivers OAA services and improve program implementation, with the ultimate goal of ensuring that the growing population of older adults can continue to receive the services and supports they need to live and thrive in their homes and communities. The rule will take effect on March 15, 2024, but regulated entities have until October 1, 2025, to comply. ACL will collaborate with partners in the aging network to implement this final rule. There will be an opportunity for states to request a corrective action plan for additional time to fully implement the rule requirements.
The updated regulations reinforce and clarify policies and expectations, provide guidance for programs authorized since the last update, promote appropriate stewardship of OAA resources, and incorporate lessons learned during the COVID-19 pandemic. For example, the final rule:
- Clarifies requirements for state and area plans on aging and details requirements for coordination among tribal, state, and local programs.
- Improves consistency of definitions and operations between state and tribal programs.
- Clarifies and strengthens provisions for meeting OAA requirements for prioritizing people with the greatest social and economic needs.
- Specifies the broad range of people who can receive services, how funds can be used, fiscal requirements, and other requirements that apply across programs.
- Clarifies required state and local agency policies and procedures. For example, the final rule establishes expectations regarding conflicts of interest.
- Requires state agencies to maintain flexible and streamlined processes for area agencies on aging to receive approval to establish contracts and commercial relationships.
- Includes guidance for the National Family Caregiver Support Program and the Native American Caregiver Support Program, which were authorized since the last update.
- Addresses emergency preparedness and response, incorporating lessons from the COVID-19 pandemic.
- Establishes expectations for legal assistance and activities to prevent elder abuse.
- Clarifies the role of the aging network in defending against the imposition of guardianship and in promoting alternatives to guardianship.
- Updates definitions, modernizes requirements, and clarifies flexibilities within the OAA nutrition programs. For example, the rule allows for continuation of innovations developed during the pandemic, such as providing carry-out meals through the congregate meals program (in some circumstances).
For additional information, watch the archived ACL webinar.
CMS updates Medicare Disparities Mapping Tool to include Medicare Advantage data
The Centers for Medicare & Medicaid Services (CMS) CMS has updated the Mapping Medicare Disparities (MMD) Tool to include 2018 Medicare Advantage data and new visual enhancements. The tool is an interactive map that provides a population view to look at data on a national, state, or local level, and the hospital view, which looks at hospital quality and costs of care at the county level. The tool can identify disparities between subgroups of people with Medicare (e.g., racial and ethnic groups) in health outcomes, utilization, and spending. It is a starting point for understanding and investigating geographic, racial, and ethnic differences in health outcomes. Previously, the MMD Tool used only Medicare Fee-for-Service data but now includes Medicare Advantage data. The tool is available in English and Spanish.
CMS releases transcripts from Medicare drug price negotiation program listening sessions
The Centers for Medicare & Medicaid Services (CMS) has released transcripts from 10 patient-focused listening sessions, one for each of the selected drugs, as part of the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. The listening sessions took place between October 30 and November 15, 2023. The sessions were intended toprovided an opportunity for patients, caregivers, consumer and patient organizations, and other interested parties to share input relevant to the drugs selected for the first cycle of negotiation, which are covered under Medicare Part D. For further information about the listening sessions email IRARebateAndNegotiation@cms.hhs.gov with the subject line “Patient-Focused Listening Sessions.”
FDA issues final guidance on charging for investigational drugs under an IND
The U.S. Food and Drug Administration (FDA) has issued a a final guidance (Docket No. FDA-2013-D-0447) for industry entitled “Charging for Investigational Drugs Under an IND: Questions and Answers.” This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016. FDA considered comments received on the revised draft guidance as the guidance was finalized. Changes from the revised draft to the final guidance address the inclusion of information about charging for investigational drugs in the informed consent document and provide the definition of intermediate-size patient population expanded access. In addition, editorial changes were made to improve clarity.
Factors influencing provider burnout in Federally Qualified Health Centers
Pressures related to patient care and lower job satisfaction were linked to higher provider burnout in Federally Qualified Health Centers (FQHCs), according to an Agency for Healthcare Research and Quality (AHRQ)-funded study published in the Journal of General Internal Medicine. Researchers conducted a cross-sectional survey of 143 providers, with 74 responding, to explore the relationship between burnout and perspectives on quality improvement, patient experience, clinic culture, and job satisfaction. About 30 percent of providers reported burnout. Overall, the rate of physician burnout dropped below 50 percent in 2019 for the first time since 2011, but it remains much higher than the burnout rate among U.S. workers in general. They concluded that the creation of environments supporting provider-team relationships and discussions about improving care, along with facilitative leadership, could protect against provider burnout.
GSA publishes dementia guide for PCPs caring for people with intellectual and developmental disabilities
A new publication from the Gerontological Society of America (GSA), Addressing Brain Health in Adults With Intellectual Disabilities and Developmental Disabilities: A Companion to the KAER Toolkit for Primary Care Providers, is designed to address the needs of adults with intellectual and developmental disabilities (I/DD) who develop dementia. It complements the GSA KAER Toolkit for Primary Care Teams, which is based on a four-step framework for addressing brain health in adults: Kickstart the brain health conversation, Assess for cognitive impairment, Evaluate for dementia, and Refer for community resources.
Adults with I/DD have a wide range of cognitive and functional capacities that may complicate assessment of cognition. Dementia may be more prevalent and occur in younger ages in certain types of I/DD, particularly Down syndrome. In other conditions, the rate of developing dementia is similar to that of the general population. The new GSA guide raises awareness of unique needs of adults living with I/DD, equips and encourages caregivers and health care teams to engage in appropriate brain health conversations with adults with I/DD, promotes brain health conversations and early detection of changes in cognitive and adaptive function for adults with I/DD, and assists with the identification of community supports and resource networks aimed at enhancing function and quality of life for adults with dementia and I/DD.
UsAgainstAlzheimer’s publishes culturally tailored brain health resources
Every February, the United States celebrates Black History Month to recognize the contributions of African Americans who have shaped the nation. To honor the lives and legacies of Black history makers who lived with Alzheimer’s or were influential in Alzheimer’s disease research, the UsAgainstAlzheimer’s Center for Brain Health Equity has created two key resources to advance health justice
- Practical Guide: Communicating Brain Health Messages with Latino and African American Communities: This guide was co-created by UsAgainstAlzheimer’s and the Centers for Disease Control and Prevention (CDC) to help public health professionals, health providers, researchers, and community-based providers incorporate the best available evidence about brain health and cognitive decline risk factors into existing messaging.
- Promoting Brain Health Equity in African American & Latino Communities (social media toolkit): This toolkit was created to put the above practical guide tips into action. Here, you will find timely and evergreen brain health messages you can customize for your African American and Latino communities. In this version, you’ll find messages specifically for Black History Month. This toolkit will be updated several times a year with timely messages.
ADvancing States issue brief addresses person-centered LTSS approaches
ADvancing States has released a new issue brief, “Person-Centered Approaches: Connecting Individuals to Services and Benefits,” developed with support from the National Council on Aging (NCOA). The issue brief describes person-centered approaches used by human services professionals to learn about an individual’s goals, needs, and preferences to live the life they desire and value. In aging and disability networks, person-centered conversations aid in the understanding of an individual’s long-term services and supports (LTSS) needs and preferences resulting in improved access to services and benefits. Community-based organizations, including Aging and Disability Resource Centers, Area Agencies on Aging, and Benefit Enrollment Centers, can strengthen their connections and engagement with LTSS access systems through person-centered approaches and state efforts, such as No Wrong Door Systems. Additionally, the issue brief highlights state initiatives that have implemented promising person-centered approaches.
Additional Reads
- When Flies Sleep, Glia Refresh Their Brains by Burning Neuronal Lipids (read here)
- Unlocking Alzheimer’s secrets by studying neuropsychiatric symptoms (read here)
- A journey through neuroscience: big data and the puzzle of dementia resilience (read here)
- Associations of 24‐Hour Rest‐Activity Rhythm Fragmentation, Cognitive Decline, and Postmortem Locus Coeruleus Hypopigmentation in Alzheimer’s Disease (read here)
- Looming budget cuts are keeping the new NIH director up at night (read here)
- Untangling a sticky mystery: Researchers make precious headway into a genetic form of Alzheimer’s disease (read here)
- Is the 100-year old TB vaccine a new weapon against Alzheimer’s? (read here)
- Large Proteomic Study Flags Blood Biomarkers That Could Foretell Dementia (read here)
- Bipartisan group of lawmakers opposes Biden’s plan to use ‘march-in’ to lower drug prices (read here)
- Yoga provides unique cognitive benefits to older women at risk of Alzheimer’s disease, study finds (read here)
- Cell Engineering Team Links Cancer Drug to Potential Therapy for Alzheimer’s Disease and Long-COVID Risk for It (read here)
- Cracking the Code of Neurodegeneration: New Model Identifies Potential Therapeutic Target (read here)
- Alzheimer’s blood test performs as well as FDA-approved spinal fluid tests (read here)
- Biomarker Changes during 20 Years Preceding Alzheimer’s Disease (read here)
- Association of PM2.5 Exposure and Alzheimer Disease Pathology in Brain Bank Donors—Effect Modification by APOE Genotype (read here)
- Can We Find a Cure for Alzheimer’s Disease? (read here)
- Silent Brain Changes Precede Alzheimer’s. Researchers Have New Clues About Which Come First (read here)
- Dementia: Researchers link the stress response to brain cell death (read here)
- An Army Vet’s 23&Me Test Inspired Him to Join a Clinical Trial. There, He Learned He Had Early Signs of Alzheimer’s (read here)
- Statins may lower risk for any dementia among adults with heart failure (read here)
- In Diabetes, Tight Blood Sugar Control Staves Off Dementia (read here)
- How AI Can Help Spot Early Risk Factors for Alzheimer’s Disease (read here)
- Air pollution could be significant cause of dementia – even for those not predisposed (read here)
- Alzheimer’s Disease vs Dementia: Nomenclature Matters (read here)
- “Back to Braak”: Role of Nucleus Reuniens and Subcortical Pathways in Alzheimer’s Disease Progression (read here)
- The killer instinct: Using natural killer therapy to treat Alzheimer’s (read here)
- “Nobody seems to care”: Dementia caregivers and COVID-19 (read here)
- House Democrats reiterate call for FDA to work on clinical diversity action plans (read here)
- Fixing rogue brain cells may hold key to preventing neurodegeneration (read here)
- Alzheimer’s disease: Viagra is seen as a potential treatment, but the research shows contradictory findings (read here)
- New treatment reverses Alzheimers disease signs improves memory function (read here)
- Blocking Key Protein May Halt Alzheimer’s Progression (read here)
- Drug Repairs Systems That Drain Alzheimer’s-Causing Waste From Brain, Study Shows (read here)
- Virginia Tech researchers find that muscle function could lead to early Alzheimer’s diagnosis (read here)
- Dementia can be predicted more than a decade before diagnosis with these blood proteins (read here)
- WVU researchers use AI to predict, detect Alzheimer’s disease (read here)
- Microbiome studies explore why more women develop Alzheimer’s disease (read here)
- Why the brain’s microbiome could hold the key to curing Alzheimer’s (read here)
- HKUST Neuroscientists Develop Highly Accurate Universal Diagnostic Blood Test for Alzheimer’s Disease and Mild Cognitive Impairment (read here)
- Proteomics Uncovers Potential Markers of Early Autosomal Dominant AD (read here)
- Wastewater clues could revolutionize Alzheimer’s detection (read here)
- Alzheimer’s disease: Animal study looks at potential new treatment (read here)
- Demographic, clinical, biomarker, and neuropathological correlates of posterior cortical atrophy: an international cohort study and individual participant data meta-analysis (read here)
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Protein modifications key influencers in neurodegenerative diseases (read here)
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Tracing synaptic loss in Alzheimer’s brain with SV2A PET‐tracer UCB‐J (read here)
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New genetic therapy could be a gamechanger for MND and frontotemporal dementia (read here)
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Epigenetic Shenanigans—In AD, Chromatin Opens Up in Blood Immune Cells (read here)
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Dementia: Could a new blood test predict it 15 years before symptoms? (read here)
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Pattern of thinning may predict dementia risk a decade before symptoms (read here)
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Family-based study identifies potential new genetic factors linked to Alzheimer’s risk in people with African ancestry (read here)
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Helping caregivers help people with dementia eat at home (read here)
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Dementia Researchers Share Recruitment Strategies for Pragmatic Clinical Trial (read here)
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Double risk of dementia after mouth ulcer virus (read here)
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Drug for Agitation in Alzheimer Disease Dementia Fails in Phase 3 Trial (read here)
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UC Irvine-led research team creates novel rabies viral vectors for neural circuit mapping (read here)
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Immune Genes Are Altered in Alzheimer’s Patients’ Blood (read here)
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Can AI Enhance MRI Detection of Amyloid-Related Abnormalities in Patients with Alzheimer’s Disease? (read here)
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The association of GNB5 with Alzheimer disease revealed by genomic analysis restricted to variants impacting gene function (read here)
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Few Nursing Facility Residents and Staff Have Received the Latest COVID-19 Vaccine (read here)
- Exposure to Agent Orange damages brain tissue in ways similar to Alzheimer’s disease (read here)
- Are stressed-out brain cells the root cause of neurodegenerative disease? (read here)
- Oxytocin: The Love Hormone That Holds the Key to Better Memory (read here)
- Novel blood metabolite biomarkers linked to Alzheimer’s disease (read here)
- Plasma proteomic profiles predict future dementia in healthy adults (read here)
- APOE traffics to astrocyte lipid droplets and modulates triglyceride saturation and droplet size (read here)
- ChatGPT analyzes speech patterns to identify Alzheimer’s 87 percent of the time, researchers show (read here)
- Language barriers could contribute to higher aggression in people with dementia (read here)
- Alzheimer’s Disease and Epilepsy: Basic Science Clues to the Link (read here)
- Study Highlights Financial Burden of Dementia on Older Adults, Families (read here)
- Cerebrospinal fluid biomarker panel for synaptic dysfunction in a broad spectrum of neurodegenerative diseases (read here)
- Phosphodiesterase Type 5 Inhibitors in Men With Erectile Dysfunction and the Risk of Alzheimer Disease (read here)
- Selecting Alzheimer’s Patients for Anti-Amyloid Therapy (read here)
- Strongest evidence to date of brain’s ability to compensate for age-related cognitive decline (read here)
- UAMS Research Team Discovers Potential Alzheimer’s Drug (read here)
- Moving Alzheimer’s Diagnosis to Primary Care Could Ease Bottlenecks (read here)
- Lighting up Alzheimer’s-related proteins to allow for earlier disease detection (read here)
- Alzheimer’s Study Finds Potential Immune System Link, Mostly in Women (read here )
- 5 Reasons Black Americans Have Higher Dementia Risk (read here)
- Impact of frailty severity and severe pain on cognitive function for community-dwelling older adults with arthritis: a cross-sectional study in Korea (read here)
- Local structural preferences in shaping tau amyloid polymorphism (read here)
- No major effect of dopamine receptor 1/5 antagonist SCH‐23390 on epileptic activity in the Tg2576 mouse model of amyloidosis (read here)
- Dementia risk may nearly triple in first year after a stroke (read here)
- When a Spouse Goes to the Nursing Home (read here)
- How a natural protein can help fight Alzheimer’s disease (read here)
- Early onset diagnosis in Alzheimer’s disease patients via amyloid-β oligomers-sensing probe in cerebrospinal fluid (read here)
- Buck Scientists Discover a Potential Way to Repair Synapses Damaged in Alzheimer’s Disease (read here)
- A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial (read here)
- Posterior Cortical Atrophy Is a Form of Young-Onset Alzheimer’s (read here)
- Alzheimer’s may have once spread from person to person, but the risk of that happening today is incredibly low (read here)
- First Evidence for Transmitted Alzheimer’s Disease? (read here)
January, 2024 News
Congress extends appropriations CR
Congress has passed, and the President has signed, a new appropriations continuing resolution (CR) covering Agriculture-FDA, Energy-Water, Military Construction-VA, and Transportation-HUD until March 1, and the remaining eight appropriations bills (including Labor-HHS and Commerce, Justice, Science) until March 8. While congressional leaders have agreed on a $1.66 trillion spending cap for Fiscal Year 2024, they continue negotiating how the funds will be distributed among federal agencies and programs. Earlier this month, the LEAD Coalition joined with nearly 1,100 organizations on a Coalition for Health Funding letter urging Congress to reject any full-year CR that would result in cuts to non-defense discretionary (NDD) programs and instead adopt the bipartisan Senate funding framework for the Fiscal Year 2024 spending agreement. For additional details and analysis, read articles from The Hill, Roll Call, and the Washington Post.
FDA and CMS issue joint statement on oversight of laboratory developed tests
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement reiterating mutual support of the FDA’s oversight of laboratory developed tests (LDTs), including the analytical and clinical validity of these tests. LDTs help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure these tests work and that patients along with health care providers are able to have warranted confidence that laboratory tests work. Therefore, last October, the FDA issued a notice of proposed rulemaking (Docket No. FDA-2023-N-2177) to help ensure the safety and effectiveness of LDTs by phasing out the FDA’s current approach to LDTs. If finalized, LDTs generally would fall under the same enforcement approach as other tests. CMS supports the FDA’s proposal.
FDA approves AI tool to predict progression from aMCI to Alzheimer’s dementia
The U.S. Food and Drug Administration (FDA) has issued a De Novo approval (DEN220066) to Darmiyan, Inc. for its BrainSee technology , which uses cutting-edge image processing and medical artificial intelligence (AI) to predict progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia within 5 years. Brainsee requires a common 3D MRI scan, with no contrast injections, along with cognitive test scores collected during a conventional diagnostic workup. This enables proactive brain health management, offering a non-invasive and widely scalable screening option that can be applied before other FDA-approved tests or treatments. In a 2020 study, BRainsee achieved high performance accuracy and consistency in measuring Alzheimer’s-related abnormalities. The test-retest consistency had a correlation coefficient of 99.5%. Subsequently, the FDA granted a breakthrough designation in 2021. For additional information, see coverage in AlzForum.
CMS details American Rescue Plan state spending plans for HCBS
The Centers for Medicare & Medicaid Services (CMS) has released state spending plan summaries for section 9817 of the American Rescue Plan Act of 2021 (ARP). The spending plan summaries illustrate how states expect to spend $36.8 billion on activities to enhance, expand, or strengthen home and community-based services (HCBS) under Medicaid. Activities focus on workforce recruitment, retention, and training, quality improvement, reducing or eliminating waiting lists, expansions of the use of technology, opportunities to support caregivers, and ways to address social determinants of health and promote equity.
AHRQ updates its research priorities
The Agency for Healthcare Research and Quality (AHRQ) has updated its research priorities to ensure that research investments address the most pressing challenges in healthcare delivery and have the greatest possible impact on patient outcomes. The priority areas guide health services research investigator-initiated grant applications submitted to response to agency Notices of Funding Opportunity. The priorities are:
- Research on patient safety: As the lead federal agency for advancing patient safety, AHRQ invests in research and implementation projects that bridge the gap between research and the delivery of safer patient care. An important element of this work is research on the prevention and control of healthcare-associated infections.
- Research to improve healthcare delivery and practice improvement: AHRQ supports research that advances understanding of how to improve healthcare delivery, with an emphasis on strengthening primary care.
- Research to enhance whole-person healthcare delivery: AHRQ supports research on the delivery of person-centered healthcare. As part of this effort, agency investments are aimed at eliminating health inequities across the life course while emphasizing the needs of older adults and children with complex medical conditions.
Three new members join USPSTF
The Agency for Healthcare Research and Quality (AHRQ) has appointed three new members to the U.S. Preventive Services Task Force (USPSTF) who will serve four-year terms, beginning this month. Dr. Sei Lee is a professor of medicine in the Division of Geriatrics at the University of California, San Francisco, and the Senior Scholar for the San Francisco Veterans Affairs Quality Scholars fellowship. Dr. Lee also chairs the American Geriatrics Society Quality and Performance Measurement Committee. He is a geriatrician and palliative care physician and has cared for patients in the clinic, hospital, and nursing home settings. Dr. Tonette Krousel-Wood is a professor and the Jack Aron endowed chair in primary care medicine in the Tulane School of Medicine Department of Medicine. She is the founding director of the Tulane Center for Health Outcomes, Implementation, and Community Engaged Science (CHOICES). She serves in several leadership roles at Tulane, including as the associate provost for the health sciences, senior associate dean of faculty in the School of Medicine, and associate dean for public health and medical education. Dr. Sarah Wiehe is the Jean and Jerry Bepko professor of pediatrics and associate dean of community and translational research at Indiana University School of Medicine. She is a research scientist at the Regenstrief Institute and adjunct professor of epidemiology at Fairbanks School of Public Health at Indiana University. Dr. Wiehe co-directs the Indiana Clinical and Translational Sciences Institute and leads its community engagement program. Full biographies for the new members and all USPSTF members are available here. AHRQ is accepting nominations until the March 15 deadline for members to begin service in 2025.
LEAD Coalition welcomes new member organization
The LEAD Coalition recently welcomed TauRx as its newest member organization. TauRx was founded in 2002 in Singapore, with primary research facilities and operation based in Aberdeen, UK. The company has dedicated the past two decades to developing treatments and diagnostics for Alzheimer’s and other neurodegenerative diseases due to tau protein aggregation pathology. TauRx will contribute to addressing this unmet need with data from the completed Phase 3 LUCIDITY trial and pursuit of regulatory approvals in line with its overall plans to make hydromethylthionine mesylate (HMTM) available to patients and pursue clinical development in other related neurodegenerative diseases.
RAND issues report on role of primary care in avoiding Alzheimer’s disease treatment bottlenecks
According to a new RAND report, “Modeling Early Detection and Geographic Variation in Health System Capacity for Alzheimer’s Disease–Modifying Therapies,”engaging primary care providers (PCPs) may be a key to accelerating delivery of emerging Alzheimer’s disease treatments, particularly given substantial variations in health care system capacity to diagnose and treat early stage disease. The report found that enabling PCPs to diagnose and evaluate patients for treatment eligibility would make the biggest impact on reducing wait times for specialists and increase the number of people treated with disease-modifying therapies from 2025 through 2044. Most PCPs do not perform cognitive assessments regularly because of time constraints with competing demands, according to the report. Creating new training for PCPs, improving reimbursement rates, and developing guidelines to streamline workflows would enable more PCPs to conduct assessments. Additionally, improved triage of patients using blood-based biomarker tests could reduce caseloads for specialists, according to researchers.
RAND researchers used a simulation model to assess patient demand and provider supply for the delivery of Alzheimer’s disease–modifying therapies, expanding on earlier RAND work that looked at the preparedness of the health care system before any such therapies were in clinical use. The model assessed items such as the number of medical specialists, availability of PET scanners used to confirm a diagnosis of Alzheimer’s, and the workforce needed to deliver the intravenous infusion treatments. The new modeling uses county-level information to illustrate the geographic variations in patient populations and health care system capacities. Using this information, the research team created an interactive tool that allows users to vary patient demand and provider capacity assumptions and to view the county-level capacity for key resources such as medical specialists and PET scanners.
ADvancing States publishes report on adult protective services
ADvancing States has published findings from the 2022 national survey of Adult Protective Services (APS) Programs in the report Adult Protective Services in 2022: Responding to Evolving Needs in a Changing Environment. ADvancing States conducted this survey to assess the current state of APS programs and identify trends related to topics such as caseload, staff retention, and client assessment. Additionally, there was a special focus placed on clients experiencing self-neglect. This report describes programmatic elements of APS, focuses on the people that the programs serve, identifies needed services, and explores opportunities to expand APS’ relationship with Medicaid.
NCAL issues review of state assisted living regulations
The National Center for Assisted Living (NCAL) recently issued its annual Assisted Living State Regulatory Review, which summarizes key selected state requirements for assisted living licensure or certification. The review provides information for every state and the District of Columbia on topics such as which state agency licenses assisted living, recent legislative and regulatory updates affecting assisted living, scope of care, limitations of services, staffing, and training. The report also includes requirements for communities that offer housing and person-centered supportive and/or health care services to older adults and people with disabilities, but may use a different term than assisted living.
High-quality nursing home dementia care is not only a matter of adding staff
Additional staffing alone will not be sufficient to bridge the quality-of-care and health outcome disparities among nursing home facilities with varying percentages of residents with dementia, according to a first-of-its-kind study led by the University of California, Irvine. Specialized training, an easy-to-navigate environment and staff stability are also critical to meeting the unique challenges presented by this population. The findings, recently published online in the journal Health Services Research, indicate that increased staffing generally improves outcomes for all patients but that at any given level of staffing, discrepancies between high- and low-dementia facilities remain. The impact on care differed by percentage of residents with dementia and various outcomes, ranging from daily activities such as independently bathing, dressing and eating to the number of emergency room visits and incidents of pressure sores. Researchers conducted regression analyses on a national sample of nursing homes between 2017 and 2019, drawing on a variety of datasets, including Medicare claims and the Centers for Medicare and Medicaid Services’ Payroll Based Journal. Independent variables included staff hours per resident-day and dementia population percentage, controlling for other resident and facility characteristics. Separate linear models were utilized to predict six long-term facility-level outcomes.
Sleep quality in midlife matters more than quantity in reducing dementia risk
A new study reveals that quality of sleep, not quantity, may play a part in the development of dementia decades before symptoms start. Unlike previous research that has primarily focused on sleep disturbance and cognitive impairment in late life, the 526 participants at the start of this study had an average age of 40. The researchers used a wrist activity monitor to record bedtime “sleep fragmentation,” which took into account the amount of time participants were immobile and the amount of time they were moving. After tracking the participants’ sleep habits and evaluating their cognitive performance years later, the researchers found no association between cognition and sleep duration, in analyzing both self-reports and data from the wrist activity monitors. In contrast, those with higher levels of fragmented sleep were found to be up to three times as likely to score below average in cognitive testing as those with lower levels of fragmented sleep, when adjusted for factors like education, depression, body mass index, diabetes and hypertension. The participants were part of CARDIA (Coronary Artery Risk Development In young Adults), a National Institutes of Health study. Over half were female; 56% were white and the remainder were Black. Their sleep habits were assessed over a three day-period on two occasions, approximately one year apart, and cognitive testing took place about 11 years later.
Additional Reads
- Deciphering Brain Connections between Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (read here)
- Overcoming the stigma: study recommends steps to move past barriers of brain health conversations (read here)
- Playing an instrument linked to better brain health in older adults (read here)
- Alzheimer’s disease acquired from historic medical treatments (read here)
- ‘When we lose our memories, our communities lose their history,’ How a lifetime of discrimination puts queer people at a higher risk of developing dementia (read here)
- Gut inflammation is associated with aging and Alzheimer’s disease (read here)
- New tool helps predict progression of Alzheimer’s (read here)
- Brain Drain – Nasopharyngeal Lymphatics Found to be Crucial for Cerebrospinal Fluid Outflow (read here)
- New Research Frameworks Proposed for the Biology of Dementia with Lewy Bodies and/or Parkinson’s Disease (read here)
- AD Blood Tests Are Here. Now, Let’s Grapple With How to Use Them (read here)
- Study finds disparities in diagnosis and treatment of dementia (read here)
- Paper Alert: p-Tau217 Blood Test Predicts Plaques, Tangles Over Time (read here)
- Protein TDP-43 keeps genetic zombies at bay (read here)
- Association Between β-Amyloid Accumulation and Incident Dementia in Individuals 80 Years or Older Without Dementia (read here)
- Association Between Sleep Quantity and Quality in Early Adulthood With Cognitive Function in Midlife (read here)
- Diagnostic Accuracy of a Plasma Phosphorylated Tau 217 Immunoassay for Alzheimer Disease Pathology (read here)
- A type of dementia that hits the brain of men and women differently (read here)
- Enhancing foveal avascular zone analysis for Alzheimer’s diagnosis with AI segmentation and machine learning using multiple radiomic features (read here)
- Thinning of brain region may signal dementia risk 5-10 years before symptoms (read here)
- Could Bizarre Visual Symptoms Be a Telltale Sign of Alzheimer’s? (read here)
- ‘It was really scary’: In the battle against dementia, support for caregivers is crucial (read here)
- Research into the nature of memory reveals how cells that store information are stabilized over time (read here)
- New cause of neuron death in Alzheimer’s discovered (read here)
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Definition of a Threshold for the Plasma Aβ42/Aβ40 Ratio Measured by Single-Molecule Array to Predict the Amyloid Status of Individuals without Dementia (read here)
- Alzheimer proteopathic tau seeds are biochemically a forme fruste of mature paired helical filaments (read here)
- New links between late-onset Alzheimer’s disease and the immune system (read here)
- Research evaluates how retina could yield early Alzheimer’s disease diagnosis (read here)
- Police Pilot New Tactics for People With Dementia as Advocates Urge Compassion (read here)
- New Findings in Football Players May Aid the Future Diagnosis and Study of Chronic Traumatic Encephalopathy (CTE) (read here)
- Dementia risk factors differ among ethnicities (read here)
- Synthetic memories: Piecing together the past with AI (read here)
- Research reveals new hope for obesity-induced heart disease (read here)
- The Accelerated Approval Regulatory Pathway With the USA FDA Commissioner Robert Califf (read here)
- Senate to examine walkaway deaths in assisted-living facilities (read here)
- Monitoring synaptic pathology in Alzheimer’s disease through fluid and PET imaging biomarkers: a comprehensive review and future perspectives (read here)
- Exploring the Role of Brexpiprazole in Alzheimer Dementia Agitation (read here)
- Statins and risks of dementia among patients with heart failure: a population-based retrospective cohort study in Hong Kong (read here)
- TREM2 variants that cause early dementia and increase Alzheimer’s disease risk affect gene splicing (read here)
- A Brief Update on Alzheimer’s Diagnosis and Treatment (read here)
- Association of long-term exposure to various ambient air pollutants, lifestyle, and genetic predisposition with incident cognitive impairment and dementia (read here)
- Combining two techniques could spot Alzheimer’s disease sooner (read here)
- Neurosurgeon works to slow Alzheimer’s progression, treat addiction with cutting-edge technology (read here)
- Evidence grows of air pollution link with dementia and stroke risk (read here)
- Dementia-friendly tourism is on the rise—here’s why it’s so important (read here)
- Flagging Dementia Patients for Better Hospital Care (read here)
- Different biological variants discovered in Alzheimer’s disease (read here)
- Blood tests can help diagnose Alzheimer’s — if they’re accurate enough. Not all are (read here)
- Generative Artificial Intelligence Models Effectively Highlight Social Determinants of Health in Doctors’ Notes (read here)
- Naomi Feil, Who Transformed Dementia Care, Dies at 91 (read here)
- Buck Scientists Identify How Dietary Restriction Slows Brain Aging & Increases Lifespan (read here)
- Is the Montreal cognitive assessment culturally valid in a diverse geriatric primary care setting? Lessons from the Bronx (read here)
- Study: Amyloid-β protein affects cognitive decline after small-sized cerebral infarction (read here)
- Cerebrospinal fluid proteomics in patients with Alzheimer’s disease reveals five molecular subtypes with distinct genetic risk profiles (read here)
- A common marker of neurological diseases may play role in healthy brains (read here)
- “Exhausted” immune cells may drive Alzheimer’s (read here)
- Brain areas lipidomics in female transgenic mouse model of Alzheimer’s disease(read here)
- Molecular Biomarkers to Diagnose Vascular Cognitive Impairment and Dementia(read here)
- Is It a Quirky Behavior or Alzheimer’s? (read here)
- How Do You Explain Dementia to a Child? (read here)
- Neural stem cell homeostasis is affected in cortical organoids carrying a mutation in Angiogenin (read here)
- Upping the Ante for Predicting the Success of Alzheimer Disease Treatments (read here)
- Similar Risk Factors Found for Young- and Late-Onset Dementia (read here)
- Alzheimer’s Disease: The Past, Present, and Future of a Globally Progressive Disease (read here)
- Exploring the ANGPT-TIE Signaling Pathway in Alzheimer’s Disease: Potential Therapeutic Opportunities (read here)
- Hearing loss increases the risk of dementia ((read here)
- Hearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults (read here)
- My Parents’ Dementia Felt Like the End of Joy. Then Came the Robots. (read here)
- Cryptic splicing of stathmin‑2 and UNC13A mRNAs is a pathological hallmark of TDP‑43‑associated Alzheimer’s disease (read here)
- Ultrasound Blood–Brain Barrier Opening and Aducanumab in Alzheimer’s Disease(read here)
- Football linked to damage of white matter in brain, a marker of dementia (read here)
- NIA at 50: Celebrating aging research advances and career opportunities (read here)
- Clinical staging of behavioral and psychological symptoms of dementia (read here)
- Association Between Sleep Quantity and Quality in Early Adulthood With Cognitive Function in Midlife (read here)
- Balancing Autonomy And Public Safety: A Call For Medical And Regulatory Oversight Of Drivers With Cognitive Decline(read here)
- Atypical instantaneous spatio-temporal patterns of neural dynamics in Alzheimer’s disease(read here)
- Native PLGA nanoparticles attenuate Aβ-seed induced tau aggregation under in vitro conditions: potential implication in Alzheimer’s disease pathology(read here)
- Alzheimer Agent Lomecel-B Meets Primary End Point in Phase 2a CLEAR MIND Study(read here)
- Deep Brain Stimulation May Benefit Patients With Alzheimer Disease, But More Research Is Needed (read here)
- Novel Alzheimer’s Trials Evaluate Senolytics, Semaglutide, CRISPR, and More (read here)
- Androgen deprivation therapy for prostate cancer and neurocognitive disorders: a systematic review and meta-analysis (read here)
- An ensemble learning model for continuous cognition assessment based on resting-state EEG (read here)
- Heterogeneous factors influence social cognition across diverse settings in brain health and age-related diseases (read here)
- Association between surgery and rate of incident dementia in older adults: A population‐based retrospective cohort study (read here)
- scMD facilitates cell type deconvolution using single-cell DNA methylation references (read here)
- Tripartite motif-containing protein 11 (TRIM11): a novel weapon against Alzheimer’s disease (read here)
- Alzheimer’s: ‘Cultivating hope is an act of resilience’ (read here)
December, 2023 News
HHS releases National Alzheimer’s Plan 2023 Update
U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra has released HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition. The plan is developed with input from agencies across HHS and other federal departments as well as recommendations from the Advisory Council, whose members include healthcare providers, researchers, caregivers, individuals living with dementia, state representatives, and advocates. For additional information, see the HHS statement.
FDA publishes three new guidances on real world evidence and data
The U.S. Food and Drug Administration (FDA) has published a series of guidances to help advance real world evidence (RWE) and real world data (RWD) and recently published three additional guidances in this series:
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, which updates and clarifies how the FDA evaluates RWD to determine if it is sufficient to be used in regulatory decision making for medical devices and provides expanded recommendations for sponsors collecting RWD. (Federal Register Docket No. FDA-2023-D-4395)
- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, which provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. (Federal Register Docket No. FDA-2021-D-1146)
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data, which addresses considerations for the use of data standards currently supported by the FDA in applicable drug submissions containing study data derived from RWD sources. (Federal Register Docket No. FDA-2021-D-0548)
Supporting a robust data infrastructure, developing new methods and analytical tools, and integrating RWE with traditional clinical trial evidence will require collaboration across the clinical care, research and technology sectors, in addition to direct involvement of patients. To help in this context, the FDA is supporting research or demonstration projects that seek to improve the quality of RWD and RWE. Strengthening systems for generating and gathering new and better data and analyzing those data is vital to provide reliable evidence to inform and improve the many decisions made by consumers, patients, families, clinicians and regulators. The FDA already is capable of reviewing submissions that include or rely entirely on RWD. Enabling advanced data analytics, including RWD, also is incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. Ongoing agency initiatives will continue to promote awareness of, and consistency in, reviewing submissions with RWD.
FDA issues final guidance for rare disease drugs and biologics
The U.S. Food and Drug Administration (FDA) has issued final guidance to assist sponsors of drugs and biological products for treatment of rare diseases in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development. This guidance, entitled “Rare Diseases: Considerations for the Development of Drugs and Biological Products,” finalizes the draft guidance entitled “Rare Diseases: Common Issues in Drug Development” issued on February 1, 2019. This final guidance addresses important aspects of drug and biological product development to support the proposed clinical investigation(s), including nonclinical pharmacology/toxicology; trial design and endpoint considerations to ensure quality and interpretability of data; standard of evidence to establish safety and effectiveness; and drug manufacturing considerations during drug development. Changes made from the draft to the final guidance took into consideration comments received. Major changes include the removal of the natural history section (because this is addressed in a separate guidance), additional considerations regarding nonclinical studies, information on the use of external controls and early randomization, a section discussing safety considerations, information on changes to drug substance or manufacturing process, and sections discussing participation of patients/patient groups in drug development programs and pediatric considerations in rare disease drug development. For additional details, see the Federal Register notice (Docket No. FDA-2015-D-2818).
CMS issues information bulletin on HCBS worker registries
The Centers for Medicare & Medicaid Services (CMS) has released an information bulletin outlining how states can use worker registries for Medicaid-funded home and community-based services (HCBS) to ensure beneficiaries have awareness of, and access to, qualified workers to deliver these critical services. The guidance focuses on building and maintaining worker registries — worker management platforms that make qualified health workers easier to find — so more individuals receiving Medicaid-covered services can get care in a setting of their choice. The guidance also notes that significant federal funding is available through the American Rescue Plan (ARP) to help states build these registries. CMS also released data on how enhanced funding for HCBS, provided through the ARP, has been invested to strengthen access to HCBS nationwide. The funding includes investments to help retain, expand, and train the direct care workforce, as well as investments to support family caregivers and reduce or eliminate waitlists for community-based care.
Report recommends action to address the direct care workforce shortage
The Bipartisan Policy Center has unveiled a report, Addressing the Direct Care Workforce Shortage: A Bipartisan Call to Action, highlighting the critical shortage of direct care workers in the United States and underscoring the urgent need for federal policy reforms to address this escalating crisis. Addressing these challenges is critical to not only ensuring a robust direct care workforce, but also to promoting gender and racial equity, as the current workforce is comprised disproportionately of women (86%), people of color (60%), and immigrants (25%). This moment also presents an important opportunity for federal policymakers to improve care access and quality while making progress in fully integrating individuals with disabilities into the community, as required by the Supreme Court in Olmstead v. L.C., 527 U.S. 581 (1999).
This report includes bipartisan legislative and administrative federal policy solutions to (1) promote retention of direct care workers through reforms that encourage more supportive work environments, including assisting unpaid caregivers who incur significant financial burdens while relieving pressure on the paid workforce; (2) increase the number of workers through domestic and immigration policy reforms; and (3) improve standardized data collection and publicly available data on the direct care workforce to measure the effects of these efforts and inform evidence-based policymaking.
Serotonin loss may contribute to cognitive decline in early stages of Alzheimer’s disease
Comparing PET scans of more than 90 adults with and without mild cognitive impairment (MCI), researchers found that relatively lower levels of serotonin in parts of the brain of those with MCI may play a role in memory problems including Alzheimer’s disease. The findings, published in the Journal of Alzheimer’s Disease, support growing evidence that measurable changes in the brain happen in people with mild memory problems long before an Alzheimer’s diagnosis and may offer novel targets for treatments to slow or stop disease progression. The investigators cautioned that their study showed a correlation between lower serotonin transporter levels and memory problems in MCI and was not designed to show causation or the role of serotonin in the progression from MCI to AD. To answer these questions, further research is needed to study over time healthy controls and individuals with MCI to demonstrate the role of serotonin in disease progression.
Additional Reads
- Alzheimer’s Microglial Risk Gene INPP5D Revs Up Inflammasome (read here)
- The healthcare system continues to discriminate against Alzheimer’s patients (read here)
- Dementia has allowed my mum to live in the present. If she can forget, then maybe so can I (read here)
- Daily learning test can detect Alzheimer’s disease-related changes in memory among cognitively normal older adults (read here)
- Negative Wealth Shock and Cognitive Decline and Dementia in US Adults (read here)
- Alcohol misuse and loneliness ‘increase risk of early-onset dementia’ (read here)
- Plaques Kick Neocortical Neurons into Overdrive, Entangling Tau (read here)
- Risk of young-onset dementia could be reduced through targeting health and lifestyle factors (read here)
- Bolstering our sense of smell may reduce the risk of dementia (read here)
- How these six simple acts could reduce your risk of Alzheimer’s (read here)
- New Atlas Charts Mouse Brain in Exquisite Detail(read here)
- Predicting Alzheimer’s Dementia in Oldest of the Old(read here)
- Midlife blood test may predict cognitive decline, Alzheimer’s in later life (read here)
- ‘Slide-tags’ Method Sharpens Spatial Transcriptomics (read here)
- Home-Delivered Meals and Nursing Home Placement Among People With Dementia (read here)
- Digital training programme improves quality of life for care residents with dementia – even during the Covid-19 pandemic(read here)
- Finding that statins could slow dementia stimulates further research (read here)
- New treatment reverses Alzheimer’s disease signs, improves memory function in preclinical study (read here)
- “They Will Come at Me”: New Study Investigates Fear of Retaliation in America’s Nursing Homes (read here)
- Common drug for cardiac failure jams a debated blood test for Alzheimer’s disease (read here)
- Audiovisual gamma stimulation for the treatment of neurodegeneration (read here)
- Taking out the cellular trash (read here)
- What You Can Do Now to Prevent Memory Loss (read here)
- Alzheimer’s Discovery Reveals Dire Effect of Toxic Tau Protein (read here)
- How one designer is helping dementia patients unlock forgotten memories (read here)
- APOE Christchurch Variant Tames Tangles and Gliosis in Mice (read here)
- Serum proinsulin levels as peripheral blood biomarkers in patients with cognitive impairment (read here)
- Dozens of assisted-living residents died after wandering away unnoticed (read here)
- The iceberg of dementia risk: empirical and conceptual arguments in favor of structural interventions for brain health (read here)
- Cerebral organoids with chromosome 21 trisomy secrete Alzheimer’s disease-related soluble aggregates detectable by single-molecule-fluorescence and super-resolution microscopy (read here)
- Trends in Incident Dementia Diagnosis Before and After Risk Adjustment (read here)
- Polygenic Scores Point to Microglia, Astrocytes in Alzheimer’s Pathogenesis (read here)
- Cerebral organoids with chromosome 21 trisomy secrete Alzheimer’s disease-related soluble aggregates detectable by single-molecule-fluorescence and super-resolution microscopy (read here)
- Human-derived air–liquid interface cultures decipher Alzheimer’s disease–SARS-CoV-2 crosstalk in the olfactory mucosa (read here)
- Infection with stomach bacteria may increase risk of Alzheimer’s disease (read here)
- Stigma and language barriers complicate treating Hispanics with Alzheimer’s disease (read here)
- Immunotherapies for Alzheimer’s disease (read here)
- How Holiday Rituals Can Comfort Grieving Family Caregivers (read here)
- How to Donate Your Brain to Science: For Dementia Families, It’s a Complex Process (read here)
- Saliva: A means to detect pain in people with dementia (read here)
- CSIRO tools used to discover two new genetic variants for Alzheimer’s disease (read here)
- A new study that links specific personality traits to dementia risk could open the door for new approaches to prevention and treatment. (read here)
- Are T Cells to Blame for Cognitive Impairment Caused by Hypertension? (read here)
- Oligodendrocytes and neurons contribute to amyloid-β deposition in Alzheimer’s disease (read here)
- How CRISPR gene editing could help treat Alzheimer’s (read here)
- Clues to preventing Alzheimer’s come from patient who, despite genetics, evaded disease (read here)
- Using deep long-read RNAseq in Alzheimer’s disease brain to assess medical relevance of RNA isoform diversity (read here)
- Nanoparticle-delivered RNA reduces neuroinflammation in lab tests (read here)
- Study Reveals a Protein Called Snail May Play a Role in Healing Brain Injury (read here)
- Alzheimer’s in one sibling raises risk of shortened lifespan in others (read here)
- Dysfunctional muscle mitochondria linked to higher dementia risk (read here)
- Studies have ramifications for Alzheimer’s drug development, immunotherapies (read here)
- Could visiting a museum be the secret to a healthy life? (read here)
- Study Shows How Sex Differences Play a Role in Alzheimer’s (read here)
- Changes in the Diagnostic Process of Alzheimer Disease: A New Era of Blood-Based Approaches (read here)
- Researchers Determine Structural Basis for ApoE-Aβ Interactions (read here)
- Preparing for a new chapter: disease modifying treatments for early Alzheimer’s disease (read here)
- Study Suggests Serotonin Loss May Contribute to Cognitive Decline in the Early Stages of Alzheimer’s Disease (read here)
- Could fasting reset the body’s clock and protect the brain against Alzheimer’s? (read here)
- More people with dementia opting to age in place over senior living (read here)
- Light Therapy Shines in Treating Alzheimer’s Sleep and Mood Issues (read here)
- Why do some older adults show declines in their spatial memory? (read here)
- TAF15 amyloid filaments in frontotemporal lobar degeneration (read here)
- Twice daily electrical stimulation may boost mental processes in Alzheimer’s disease (read here)
- HKBU-led research develops novel drug delivery system for Gouteng compound for Alzheimer’s disease treatment (read here)
- New Alzheimer Europe publication highlights continuing inequalities in access to dementia care and treatment across Europe (read here)
- Study reveals dementia patients may benefit from listening to personalized music (read here)
- Immune Protein May Induce Dementia Unrelated to High Blood Pressure (read here)
- Efficacy and Safety of Cilostazol in Mild Cognitive Impairment (read here)
- Salty immune cells surrounding the brain linked to hypertension-induced dementia (read here)
- Desperate Families Search for Affordable Home Care (read here)
- Housing Instability Tied to Higher Risk for Dementia Diagnosis (read here)
- Longitudinal Sleep Patterns and Cognitive Impairment in Older Adults (read here)
- Efficacy and Safety of Cilostazol in Mild Cognitive Impairment (read here)
- Music compensates for altered gene expression in age-related cognitive disorders (read here)
- Hypertensive disorders of pregnancy and the risk of dementia: a systematic review and meta-analysis of cohort studies (read here)
- Two New p-Tau217 Blood Tests Join a Crowded Field (read here)
- Dementia and Postoperative Delirium in Surgical Hip Fracture Patients: Unveiling Contrasting Risk Factors and Implications (read here)
November, 2023 News
Acadia Pharmaceuticals initiates Phase 2 clinical trial for treatment of Alzheimer’s disease psychosis
Acadia Pharmaceuticals Inc. has announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP), for which there is a large unmet medical need and no FDA-approved medication. Of the more than 6.5 million people in the United States living with Alzheimer’s disease, approximately 30% will experience psychosis, commonly consisting of hallucinations and delusions. The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo. The primary endpoint is change from baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions sub-scales (SAPS-H+D) total score at Week 6. The clinical trial sites will enroll seamlessly from Phase 2 into Phase 3. Each of the planned Phase 3 studies will enroll approximately 378 patients with ADP. Patients who complete the study will have the option of participating in a long-term open-label extension study. ACP-204 works primarily as an inverse agonist at the 5-HT2A receptor. For more information about this study contactmedicalinformation@acadia.com.
CMS issues final rule on ownership of nursing facilities
The Centers for Medicare & Medicaid Services (CMS) has released a final rule, “Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Medicare Providers’ and Suppliers’ Disclosure of Private Equity Companies and Real Estate Investment Trusts,” that will implement portions of section 6101 of the Affordable Care Act, requiring the disclosure of certain ownership, managerial, and other information regarding nursing homes. The final rule also defines the terms “private equity company” and “real estate investment trust,” about which information must be disclosed on the Medicare enrollment application. Section 6101(a) of the Affordable Care Act added section 1124(c) to the Social Security Act, establishing requirements for the disclosure of information about nursing home ownership and oversight. Although nursing homes currently must report certain ownership and management data to CMS and the states as part of the Medicare and Medicaid enrollment processes, some of the information under section 1124(c) of the Act previously has not had to be disclosed (e.g., persons who merely furnish cash management services to a skilled nursing facility that is enrolling in Medicare). According to CMS, this additional data will give CMS and the states a more complete background on the organizations and individuals that own, oversee, and facilitate the operations of nursing homes. For additional details, see the CMS statement.
FDA issues final rule on direct-to-consumer prescription drug ads
The U.S. Food and Drug Administration (FDA) has published the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule.” The final rule establishes standards to implement the statutory requirement that certain direct-to-consumer human prescription drug television and radio ads present the drug’s major side effects and contraindications, known as the “major statement,” in a clear, conspicuous, and neutral manner. The standards under the rule include:
- The information uses consumer-friendly language and terms that are easily understandable.
- The audio information in the major statement is at least as understandable as the audio information in the rest of the ad.
- In ads in TV format, the information is presented concurrently using both audio and text (dual modality); to achieve dual modality
- Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio; and
- The text is displayed for a sufficient duration to allow it to be read easily. (For purposes of this standard, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio.)
- In ads in TV format, the information in text is formatted so the information can be read easily.
- The ad does not include audio or visual elements when the major statement is presented that can interfere with understanding the major statement.
Senate confirms new NIH Director
The Senate has confirmed President Biden’s nominee, Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH) in a bipartisan vote. Earlier this year, the LEAD Coalition joined 114 organizations in a letter to Senate leadership urging Dr. Bertagnolli’s confirmation. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Immediately prior to taking office as NIH Director on November 9, Dr. Bertagnolli served as Director of the National Cancer Institute (NCI). For additional information, read the NIH statement and reporting by STAT.
LEAD Coalition welcomes three new member organizations
The LEAD Coalition — the uniting voice of over 260 member and allied organizations working collaboratively to accelerate transformational progress in care and support to enrich the quality of life of those with dementia and their caregivers, detection and diagnosis, and research leading to prevention, effective treatment, and cures — recently welcomed three new member organizations.
Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients living with Alzheimer’s disease (AD) and related neurodegenerative disorders. ALZ-801 (valiltramiprosate) is an investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD. It is designed to block the formation of neurotoxic soluble beta amyloid oligomers causing cognitive decline in Alzheimer’s patients.
Founded in 1988, the National Association of Chronic Disease Directors (NACDD) is a national, nonprofit, professional association that works to improve public health by strengthening state-based leadership and expertise for chronic disease prevention and control in State, Local, Tribal, and Territorial Health Departments. The Association provides a national forum for chronic disease and health promotion professionals. NACDD’s core membership is composed of the 59 State and Territorial Health Department Chronic Disease Directors and their staff who protect the health of the public through primary and secondary prevention efforts and work “upstream” on root causes of chronic conditions. In addition, NACDD unites 7,000 chronic disease professionals across the United States working in state, tribal, and territorial health departments, nonprofits, academia, and the private industry to promote health and to reduce the burden of chronic disease.
Positrigo is a pioneer in nuclear medical imaging technologies. Headquartered in Zurich, Switzerland, the medical device company was founded in 2018 as a spin-off of ETH Zurich. Positrigo’s technology, development, clinical testing and commercialization has been supported by various private investors, the Swiss government and the European Innovation Council. NeuroLF – the company’s first device – is an ultra-compact brain Positron Emission Tomography (PET) scanner which has applications in the assessment of causes of dementias, such as Alzheimer’s disease and other brain related disorders.
PHCOE on Dementia Caregiving releases new resources
The Public Health Center of Excellence (PHCOE) on Dementia Caregiving has released two new resources. A Guide on Advanced Care Planning Resources: For People Living with Dementia and Their Care Partners contains a range of tools, materials, and information related to advanced care planning, including financial, housing, medical, legal, and palliative/hospice care assistance. The guide is intended to be used primarily by people living with dementia and their care partners to help navigate and provide recommendations for effective care, services, and considerations at various stages of cognitive impairment and dementia. Public health agencies may use this guide to raise awareness and promote the use of best practices by distributing the guide to local community organizations, healthcare systems, aging services providers, and health departments for use by their constituents.
Public Health Strategies in Dementia Caregiving: A Toolkit for Public Health Agencies is designed to provide strategies and interventions that public health agencies can implement to support and elevate the work of family dementia caregivers that are consistent with the Healthy Brain Initiative Road Map. The toolkit may be useful for all public health agencies as they set and pursue their dementia caregiving goals, but especially to public health departments that were awarded funding through the BOLD Infrastructure for Alzheimer’s Act as they implement their Alzheimer’s disease and related dementias (ADRD) strategies.
KFF publishes Medicare Advantage 2024 Spotlight
The Kaiser Family Foundation (KFF) has released the issue brief, “Medicare Advantage 2024 Spotlight: First Look,” detailing the organization’s analysis of Medicare Advantage (MA) plans and Part D prescription drug plans (PDPs) available in 2024. According to the analysis, the typical beneficiary has a choice of 43 MA plans as an alternative to traditional Medicare in 2024. This is the same number as in 2023 but more than twice the number of plans that were offered in 2018. Of the 43 MA plans, 36 plans offer Part D drug coverage, on average. Additionally, individuals with traditional Medicare have a choice of 21 Medicare stand-alone PDPs for 2024. The number of D-SNPs (for dually-eligible beneficiaries) has increased substantially over the past five years, nearly doubling from 465 dual SNPs in 2019 to 851 dual SNPs in 2024. Most Medicare Advantage plans are offering extra benefits, such as vision, dental and hearing as they have in previous years. Most Medicare Advantage plans are not offering Special Supplemental Benefits for the Chronically Ill, which are extra benefits available to a subset of a plan’s enrollees, that are not primarily health related, and are specifically for chronically ill beneficiaries. However, more SNP plans than individual plans generally offer these benefits, particularly food and produce (60.0% in SNPs compared to 13.9% in individual plans).
High biological age may increase the risk of dementia
According to results from a Karolinska Institute study, people who have a higher biological age than their actual chronological age have a significantly increased risk of stroke and dementia, especially vascular dementia. The increased risk persists even if other risk factors — such as genetics, lifestyle and socioeconomics — are taken into account. To measure biological age and the link to disease, the researchers used data from the UK Biobank. The study examined a cohort of 325,000 people who were between 40 and 70 years old at the time of the first measurement. Biological age was calculated using 18 biomarkers, including blood lipids, blood sugar, blood pressure, lung function and body-mass index. The researchers then investigated the relationship between these biomarkers and the risk of developing neurodegenerative diseases within a nine-year period. When compared to chronological age, high biological age was linked to a significantly increased risk of dementia, especially vascular dementia, and ischemic stroke.
Additional Reads
- Neuronanomedicine for Alzheimer’s and Parkinson’s disease: Current progress and a guide to improve clinical translation (read here)
- Screening, Assessment, and Pharmacologic Treatment of Mild Cognitive Impairment and Early Alzheimer’s Disease: The Role for Monoclonal Antibodies (read here)
- Dancing Through Dementia: How Movement Aids Memory and Mood (read here)
- Can Health, Lifestyle Changes Protect Elders from Alzheimer’s? (read here)
- Irritability, Agitation and Anxiety in Alzheimer’s Patients Caused by Brain Inflammation, Pitt Study Says (read here)
- Many Americans with dementia can’t get the hospice care they need (read here)
- Alzheimer’s activist Rebecca Chopp recommends testing early for the disease (read here)
- Older adults’ awareness of modifiable risk and protective factors for dementia and interest in eHealth interventions for brain health: a comparison between the Netherlands and Germany (read here)
- Size of brain area linked with cognitive decline – even in people with no other warning signs of Alzheimer’s disease (read here)
- Lowering a form of brain cholesterol reduces Alzheimer’s-like damage in mice (read here)
- Eating More Whole Grains Is Associated With Less Memory Decline in African Americans (read here)
- Applying An Evidence-Based Approach To Comprehensive Dementia Care Under The New GUIDE Model (read here)
- Understanding Donanemab’s Clinical Relevance for Patients With Alzheimer Disease (read here)
- Research finds sex differences in immune response and metabolism drive Alzheimer’s disease (read here)
- Documentary offers empowered approach to dementia and Alzheimer’s disease (read here)
- Social and Behavior Factors of Alzheimer’s Disease and Related Dementias: A National Study in the U.S (read here)
- Food Insecurity, Memory, and Dementia Among US Adults Aged 50 Years and Older (read here)
- Hearing Loss is Associated with Subtle Changes in the Brain (read here)
- Black Patients Less Likely to Receive Alzheimer’s Care, Blocking Access to New Treatments (read here)
- Early study results show virtual reality can bolster caregivers, LTC seniors relationship (read here)
- A Promising Turning Point For Dementia Care: The GUIDE Model (read here)
- How a mutation in microglia elevates Alzheimer’s risk (read here)
- Lab-grown ‘small blood vessels’ point to potential treatment for major cause of stroke and vascular dementia (read here)
- “May the Force (and Size) Be with You”: Muscle Mass and Function Are Important Risk Factors for Cognitive Decline and Dementia (read here)
- Dissociable Effects of Alzheimer’s Disease-Related Cognitive Dysfunction and Aging on Functional Brain Network Segregation (read here)
- Could newborn neurons reverse Alzheimer’s? (read here)
- Gut inflammation associated with age and Alzheimer’s disease pathology: a human cohort study (read here)
- Adult Children Discuss the Trials of Caring for Their Aging Parents (read here)
- Facing Financial Ruin as Costs Soar for Elder Care (read here)
- As the workforce ages, now is the time to normalize dementia care (read here)
- This Wireless, Handheld, Non-invasive Device Detects Alzheimer’s and Parkinson’s Biomarkers (read here)
- Unlocking Blood-Brain Barrier Boosts Immunotherapy Efficacy, Lowers ARIA (read here)
- Lowering blood pressure significantly reduced dementia risk in people with hypertension (read here)
- AI that reads brain scans shows promise for finding Alzheimer’s genes (read here)
- Dysfunctional muscle mitochondria linked to higher dementia risk (read here)
- Recognizing Advanced Alzheimer’s: Signs, Support, and Care (read here)
- Constricting Life Space and Neurodegenerative Disease in Community-Dwelling Older Men (read here)
- Researchers identify new criteria to detect rapidly progressive dementia (read here)
- Scientists tame biological trigger of deadly Huntington’s disease (read here)
- Treat Before ‘Aβ Bothers Tau,’ Scientists Say at CTAD (read here)
- Alzheimer’s Disease and Weight Loss: Why It Happens and What Can Be Done (read here)
- Pharmacogenomics holds promise for personalized dementia therapies (read here)
- Accelerating development of next-generation drugs for Alzheimer’s and related dementias (read here)
- New Culprit in Amyloid Beta Accumulation and Neurodegeneration (read here)
- PET scans may predict Parkinson’s disease and Lewy body dementia in at-risk individuals (read here)
- This dementia-inclusive choir is a happy place for friends and carers (read here)
- The Arts and Advanced Dementia (read here)
- Alzheimer’s Disease: Genetic Variant Can Significantly Raise Risk (read here)
- Agitation That May Happen with Dementia Due to Alzheimer’s Disease (read here)
- Reducing poverty may reduce risk of developing dementia (read here)
- Positive Data for First and Only Treatment Approved for Agitation in Alzheimer Dementia (read here)
- Alzheimer’s Disease: The Winds of Progress (read here)
- High metabolism is an early sign of Alzheimer’s disease (read here)
- America’s Message to Families With Loved Ones Suffering From Dementia: You’re on Your Own (read here)
- To Recruit for Diverse Alzheimer Trials, Go to the People (read here)
- Border Surprise: Glia Limitans Astrocytes Sit on Brain Surface (read here)
- Researchers find the roots of tau tangles in Alzheimer’s disease (read here)
- Virtual community of long-term care and other providers commits to ‘age-friendly’ care guidelines (read here)
- Sweet spot for HRT may reduce dementia risk by nearly a third, study says (read here)
- Being bilingual slows brain ageing, and can prevent Alzheimer’s (read here)
- Brain health in over 50s deteriorated more rapidly during the pandemic (read here)
- Minimum-Staffing Rules for U.S. Nursing Homes — Opportunities and Challenges (read here)
October, 2023 News
CMS removed NCD for amyloid PET to diagnose Alzheimer’s disease
The Centers for Medicare & Medicaid Services (CMS) has announced that it is removing the national coverage determination (NCD) at § 220.6.20, ending coverage with evidence development (CED) for positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors (MACs). The 2013 amyloid PET NCD had resulted in nationwide non-coverage of amyloid PET for a full decade, with the extraordinarily limited exception of coverage (one scan per lifetime) for individuals participating in CED clinical studies.
CMS revises Civil Money Penalty Reinvestment Program
The Centers for Medicare & Medicaid Services (CMS) has issued updated guidance for the Civil Money Penalty Reinvestment Program (CMPRP) for projects to support the quality of care and life for nursing home residents in long-term care facilities certified by Medicare and Medicaid. Under the program, a portion of civil money penalty (CMP) funds for noncompliance is provided to the State to reinvest in activities that will benefit residents to protect and improve their safety and quality of care. The CMPRP revised policies clarify the allowable uses of CMP funds, with maximum funding limits per nursing home and a clear list of the non-allowable uses of CMP funds.
FDA establishes advisory committee on digital health technologies
The U.S. Food and Drug Administration is establishing a new Digital Health Advisory Committee (DHAC) to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. Digital health also includes issues such as decentralized trials, patient-generated health data, and cybersecurity. The DHAC will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. FDA is accepting nominations for DHAC membership until December 11. The committee should be fully operational in 2024.
NIH revises grant review process to improve focus on scientific merit, reduce reputational bias
The National Institutes of Health (NIH) is taking steps to simplify its process to assess the scientific merit of research grant applications and mitigate elements that have the potential to introduce bias into review. The changes will help reviewers focus on the potential for proposed research to advance scientific knowledge and improve human health. Previously, five criteria were scored individually using a common scale. The simplified review framework reorganizes these criteria into three factors; importance of research along with rigor and feasibility will be scored using a common scale while expertise and resources will be evaluated for sufficiency only and not given a numeric score. The simplified review framework will be implemented for grant applications received on or after Jan. 25, 2025.
NIH has been gathering significant feedback from the extramural community on the grant application review process, and last year NIH proposed revisions to the process through a Simplified Framework for NIH Peer Review Criteria initiative. In forming the simplified framework, NIH gathered input through a 2022 Request for Information, receiving more than 800 responses from individuals and scientific societies. Most responses were supportive of the proposed changes, and underscored the need for communication, guidance and resources well in advance of implementation.These changes contribute to NIH’s decade long effort to address potential bias in grantmaking and enable a level playing field. Additionally, these changes will reduce administrative responsibilities of peer reviewers, shifting them to NIH staff, thereby allowing reviewers to focus on the science. NIH is developing a timeline, policy rollout and trainings to support implementation of these changes. Additionally, NIH will compile feedback and conduct data analysis to evaluate the changes over time, allowing for additional modifications as necessary.
New educational resources on dementia diagnosis and treatment in surgical settings
The American College of Surgeons (ACS) recently released a suite of educational resources focused on the accurate, consistent diagnosis and appropriate treatment of dementia and cognitive impairment to promote patient safety, equitable care, and decreased hospital resource use. Resources include:
- Cognitive Impairment Screening – ACS House of Surgery Podcast: This episode features a multidisciplinary panel of experts discussing the importance of preoperative detection of cognitive impairment and dementia in the geriatric population.
- Patient and Caregiver Brochure: This brochure for patients and caregivers covers what to expect when having surgery and includes shared decision-making and treatment choice options based on conditions and surgical needs of patients.
- ACS Bulletin Article: Cognitive Screening in Older Patients May Help Optimize Outcomes: Among older surgical patients, cognitive impairment prior to surgery is prevalent and substantially increases the risk of costly and serious postoperative complications and further cognitive decline. This neurocognitive dysfunction introduces crucial factors into the surgical decision-making process and perioperative care planning, which has a wide-ranging impact on surgeons, patients, caregivers, and other members of the healthcare team.
- Toolkit: Designed for interdisciplinary teams caring for older adults undergoing surgery, this best-practice toolkit covers why preoperative cognitive assessments are important, how to talk to patients about screening cognition, a detailed overview of some varying validated screening tools currently available, and next steps section for when patients screen positive.
- The Impact of Cognitive Impairment on Surgical Decision-Making and the Care Process: Held at the 2023 ACS Quality & Safety Conference, this session featured a panel of experts discussing varying levels of dementia and the importance of screening for cognition in the preoperative setting, processes that can help a physician and patient move beyond passive informed consent to a more collaborative, patient-centered experience, and the pearls and pitfalls of advanced directives.
GAO examines use of CMS data to identify private equity ownership of nursing homes
The U.S. Government Accountability Office (GAO) recently conducted an analysis examining the complexities of using data from the Centers for Medicare & Medicaid Services (CMS) to identify ownership structures within nursing homes, with a particular focus on private equity ownership. The study highlights complexities in nursing home ownership structures and the limitations of CMS data, emphasizing the difficulty in accurately identifying private equity ownership. The report also discusses the implications of these limitations on transparency and oversight within the nursing home industry. To perform this analysis, GAO adopted a comprehensive approach, including reviewing nursing home ownership data from CMS and other sources, examining relevant documentation and research studies, and conducting interviews with CMS officials. to read one page summary and the full GAO analysis.
ADvancing States launches dementia training course
ADvancing States has launched a training course “Identifying and Understanding the Needs of People Living with Dementia and Their Caregivers,” developed in partnership with the Alzheimer’s Association. The course will further participants’ understanding of Alzheimer’s disease and other forms of dementia, and what differentiates these conditions from typical aging. Participants will learn communication strategies to provide telephone support to someone living with early-stage dementia. The course describes the impact that dementia can have on caregivers in order to prepare community resource professionals for empathetic phone interactions. Participants will strengthen their knowledge of resources to assist individuals and caregivers through learning about the role of the Alzheimer’s Association and the support that it offers to those affected by Alzheimer’s and other dementia. To access this free training course, visit the Consumer Access to Services course category on ADvancing States iQ.
ASTHO publishes best practice guide for falls prevention
the Association of State and Territorial Health Officials (ASTHO), with support from the Centers for Disease Control and Prevention (CDC), has published “Expanding Falls Prevention Through Surveillance, Community-Clinical Linkages, and Strategic Planning and Evaluation,” to address the public health impact of unintentional falls among older adults. The guide is intended to be a comprehensive resource for state health departments in understanding how to align current falls prevention efforts to support community-clinical linkages and offer strategies to assist in implementing new efforts to support these linkages.
Unintentional falls are the leading cause of injury and injury death among older adults in the United States. Each year, about 14 million older adults report falls and five million report fall injuries, leading to over $50 billion in medical costs. Older adult falls contribute to more than 900,000 hospitalizations every year. A fall-related hospitalization increases the likelihood of a long-term nursing home admission, creating either a temporary or permanent loss of independence. In 2021, there were nearly 39,000 fall-related deaths among older adults, averaging more than 100 deaths per day.
Chlorhexidine bathing routine reduces infections in nursing homes
According to a study in the New England Journal of Medicine, nursing homes using a chlorhexidine antiseptic soap bathing routine to clean the skin and nose with over-the-counter antiseptic solutions prevents serious infections and reduces the amount of antibiotic resistant organisms, such as methicillin-resistant Staphylococcus aureus (MRSA)..Annually, three million healthcare-associated infections in U.S. nursing homes cause 150,000 hospital admissions and 350,000 deaths. In the study involving nearly 14,000 residents, researchers found that nursing homes using the “decolonization” bathing routine averaged two residents per month avoiding infections that would have required transfer to the hospital. These nursing homes also reduced significantly hospital transfers due to other causes. Nursing homes that used decolonization significant reduced overall prevalence of multidrug-resistant organisms including MRSA, vancomycin-resistant Enterococci, and other bacteria.
In this 18-month study of 28 California nursing homes, researchers compared 14 facilities that continued usual bathing routines to 14 facilities that used decolonization for all residents. Decolonization included using chlorhexidine and a nasal swab with povidone-iodine (iodophor) to remove pathogens from residents’ skin and nose. These two products have been used in healthcare for over 60 years. Adherence to the decolonization bathing routine did not need to be perfect to prevent hospitalization and spread of resistant organisms: 87 percent of nursing home staff used the chlorhexidine as intended and 67 percent used the nasal swab as intended.
Additional Reads
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- Abrupt drop in blood pressure may be an early sign of dementia (read here)
- No Influence of APOE Status on Donanemab Efficacy (read here)
- Number of dementia cases could be 42% higher than previously estimated by 2040 (read here)
- Eisai Plans to Submit BLA for Subcutaneous Lecanemab After Findings Show Promising Results (read here)
- The beginning of the end for Alzheimer’s Dementia? (read here)
- Why Diagnosing Alzheimer’s Early Is So Important (read here)
- Biogen’s tau-lowering drug slows cognitive decline in early study of Alzheimer’s disease (read here)
- New studies find benefits in very early drug treatment of Alzheimer’s (read here)
- Donanemab slows disease progression, reduces amyloid in early symptomatic Alzheimer’s (read here)
- Facing dementia without a diagnosis is crushing. A new program in Kenya offers help (read here)
- Metformin Cessation and Dementia Incidence (read here)
- Do dementia villages actually work? We just don’t know (read here)
- Physicians Are Dramatically Underdiagnosing Early Cognitive Decline, a Precursor to Alzheimer’s (read here)
- Study Suggests Estrogen to Prevent Alzheimer’s Warrants Renewed Research Interest (read here)
- Validating an MRI Biomarker for Early Onset Alzheimer’s Disease (read here)
- Ensuring adequate dementia care: The beginning of the end of Alzheimer’s? (read here)
- Study on Largest Genetic Risk Factor for Alzheimer’s Points Toward New Drug Target (read here)
- Adding lifestyle coaching to treatment decreases cognitive decline in early Alzheimer’s (read here)
- Non-invasive temporal interference electrical stimulation of the human hippocampus (read here)
- Individuals Can Now Request a Blood Test for Alzheimer’s Disease: Why Some Dementia Experts Are Wary (read here)
- The Sporadic Early‐onset Alzheimer’s Disease Signature Of Atrophy: Preliminary Findings From The Longitudinal Early‐onset Alzheimer’s Disease Study (LEADS) Cohort (read here)
- Doubts abound about a new Alzheimer’s blood test (read here)
- Scientists discover links between Alzheimer’s disease and gut microbiota (read here)
- New model provides window into Alzheimer’s disease development (read here)
- We may finally know how cognitive reserve protects against Alzheimer’s (read here)
- Fluctuating blood pressure: a warning sign for dementia and heart disease (read here)
- Clinical Overview: Lecanemab Offers Hope for Patients With Alzheimer Disease (read here)
- Western researchers reveal link between Alzheimer’s disease and sex hormones (read here)
- Adults With ADHD Are at Increased Risk for Developing Dementia (read here)
- Brain fungal infection produces Alzheimer’s disease-like changes (read here)
- Dementia’s financial and family impact: New study shows outsized toll (read here)
- A New Framework for Dementia Nomenclature (read here)
- Deep learning combining FDG-PET and neurocognitive data accurately predicts MCI conversion to Alzheimer’s dementia 3-year post MCI diagnosis (read here)
- In Alzheimer’s, Tau Oligomers in Synapses Act as ‘Eat Me’ Signal (read here)
- Scientists Investigating Alzheimer’s Drug Faulted in Leaked Report (read here)
- Medicare to cover more brain scans related to Alzheimer’s drugs (read here)
- Taking a deep dive into the Alzheimer’s brain in search of understanding and new targets (read here)
- $151M Grant Will Drive New Era in Alzheimer’s Treatments (read here)
- Blood tests needed for widespread Alzheimer’s diagnosis on the way (read here)
- Can we prevent Alzheimer’s? Scientists say new tests and treatments are “a game changer” (read here)
- Bracing for a cloudy NIA budget forecast (read here)
- Certain navigational mistakes could be early signs of Alzheimer’s disease (read here)
- Dementia risk factors pose more danger for ethnic minorities, finds study (read here)
- Advanced imaging may shed light on mechanisms behind Alzheimer’s disease (read here)
- Understanding the Onset of Sporadic Alzheimer’s Disease (read here)
- It May Not Be So Typical: Distinguishing Frontotemporal Dementia From Behavioral Variant Alzheimer’s Disease (read here)
- Is the Eye the Window to Alzheimer’s? (read here)
- Insight: Down syndrome families’ fight for access to Alzheimer’s trials, treatments (read here)
- Mount Sinai Researchers First to Develop Age Prediction Model on Human Brain Tissue Using Artificial Intelligence (read here)
- Study Published by NYMC Researchers in Nature Communications Biology Unveils Crucial Link Between Diet, Inflammation and Alzheimer’s Disease (read here)
- The gene expression changes behind Alzheimer’s disease (read here)
- Could a Faulty Ubiquitin Trigger Amyloid and Tau Deposits? (read here)
- Stunning Detail: Single-Cell Studies Chart Genomic Architecture of AD (read here)
- Possible tool discovered to diagnose common contributor to vascular dementia (read here)
- New AI Technique Helps Find Alzheimer’s Drug Targets (read here)
- Even Moderate Drinking May Be Bad for Brain Health (read here)
- Are people who have long-haul COVID more at risk for Alzheimer’s? (read here)
- Protein that could help defeat Alzheimer’s and increase productive lifespan (read here)
- Study maps brain wave disruptions affecting memory recall (read here)
- Proton pump inhibitors and dementia: A nationwide population‐based study (read here)
- Scientists discover neurons that act as brain ‘glue’ to recall memories (read here)
- Multivariate GWAS of Alzheimer’s disease CSF biomarker profiles implies GRIN2D in synaptic functioning (read here)
- Graphene oxide reduces the toxicity of Alzheimer’s proteins (read here)
- Antibody Therapy Inspired by Patient Case Reduced Tau Tangles in a Preclinical Model of Alzheimer’s Disease (read here)
- Caregiving Through Dementia: a Loving and Difficult Journey (read here)
- Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial (read here)
- Study indicates possible link between chronic stress and Alzheimer’s disease (read here)
- In Forming Long-Term Memories, Vascular Cells are Crucial (read here)
- Parkinson’s Research Buoyed by Alzheimer’s Advances (read here)
- Effect of Periodontal Disease on Alzheimer’s Disease: A Systematic Review (read here)
- Promoting Equity In Clinical Decision Making: Dismantling Race-Based Medicine (read here)
- Caregiver burden in a home hospital versus traditional hospital: A secondary analysis of a randomized controlled trial (read here)
September, 2023 News
288 LEAD Coalition members and allies urge Congress to pass the CHANGE Act
NIH designates people with disabilities as a population with health disparities
On September 26, Eliseo J. Pérez-Stable, M.D., director of the National Institute on Minority Health and Health Disparities (NIMHD), designated people with disabilities as a population with health disparities for research supported by the National Institutes of Health. The decision was made in consultation with Robert Otto Valdez, Ph.D., the director of the Agency for Healthcare Research and Quality, after careful consideration of a report delivered by an NIMHD advisory council, input from the disability community and a review of the science and evidence. A separate report issued in December 2022 by the Advisory Committee to the (NIH) Director (ACD), informed by the work of the Subgroup on Individuals with Disabilities, explored similar issues faced by people with disabilities. The designation is one of several steps NIH is taking to address health disparities faced by people with disabilities and ensure their representation in NIH research. NIH also issued a notice of funding opportunity calling for research applications focused on novel and innovative approaches and interventions that address the intersecting impact of disability, race and ethnicity, and socioeconomic status on healthcare access and health outcomes. NIH also recently issued a Request for Information (RFI) inviting feedback on a proposed update to the NIH mission statement; see the LEAD Coalition’s Take Action page for details on the Mission Statement RFI).
NIMHD is the lead NIH institute on monitoring minority health and health disparities research. Designated populations experience significant disparities in their rates of illness, morbidity, mortality and survival, driven by social disadvantage, compared to the health status of the general population. A health disparity designation helps to encourage research specific to the health issues and unmet health needs of these populations. Other NIH-designated populations with health disparities include racial and ethnic minority groups, people with lower socioeconomic status, underserved rural communities and sexual and gender minority groups.
NIA launches next EUREKA Challenge
The National Institute on Aging (NIA recently announced raw the Pioneering Research for Early Prediction of Alzheimer’s and Related Dementias EUREKA (PREPARE) challenge prize to improve early detection and address diagnosis gaps among racial and ethnic groups that are underrepresented in most clinical studies and databases. To make progress, the challenge aims to address the need for:
- Data from a wider set of sources and types, including data relevant to low-resourced, underserved communities disproportionately impacted by Alzheimer’s disease and related forms of dementia (AD/ADRD) to better understand and address biases in existing data sources;
- Open, shareable data, stored in trusted repositories to determine “distributional robustness” of predictive algorithms; and
- Algorithms that meet “right to explanation” mandates (i.e., if an AI algorithm impacts people, people have a right to an explanation of how AI conclusions were reached).
For additional details about the PREPARE challenge, eligibility, and application instructions, click here.
FDA updates FAQ and issues guidance on advancing real world evidence
The U.S. Food and Drug Administration (FDA) has updated the FAQ about its Advancing Real-World Evidence (RWE) Program. The Program seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements. The Program fulfills an FDA commitment under the Prescription Drug User Fee Act (PDUFA) VII. FDA also has released guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” For a summary of the new guidance, click here.
ACL awards Center of Excellence to align health and social care
The Administration for Community Living (ACL) Office of Network Advancement (ONA) has announced a new award to USAging for the Center of Excellence (COE) to Align Health and Social Care: Enhancing Community-Based Aging and Disability Organizations to Improve Access to Long-Term Services and Supports. The project period runs through August 31, 2026. First-year funding will support development and enhancement of aging and disability organizations supported by ACL to operate as community care hubs (CCHs). A CCH is a community-focused entity that organizes and supports a network of community-based organizations providing services to address health-related social needs, typically as partners with health care or heath system providers.
Through this award, the COE will collaborate with relevant stakeholders to improve access to long-term services and supports through CCHs as part of a broader No Wrong Door (NWD) System. In this first year, the COE will administer and manage competitive sub-awards to an estimated 20 disability and aging organizations to improve their NWD access functions, with specific emphasis on the core function of care transitions and CCH capacity to coordinate referrals across health care and social services, as well as supporting individuals transitioning from hospital to home. The COE will collaborate with ACL and partners to provide technical assistance to support both new and existing CCHs, with an emphasis on organizations in ACL’s aging and disability networks. The COE also will participate in an evaluation designed by ACL’s Office of Performance and Evaluation to assess the impact of CCHs on the delivery and coordination of services that address health-related social needs.
ACL awards Innovation Lab grant to improve falls prevention
The Administration for Community Living (ACL) Office of Performance and Evaluation has announced the creation of the ACL Innovation Lab through an award to the National Council on Aging. The three-year grant will support a collaborative, multi-partner effort to build knowledge and advance fall prevention efforts across the nation. The Lab will conduct research, demonstrations, and evaluations pertaining to falls prevention among older adults, including older adults with disabilities. The award will expand ACL’s existing falls prevention efforts, advancing and disseminating knowledge and practices that prevent falls and address risk factors. The Lab’s primary goals and activities include:
- Developing a taxonomy for falls prevention research.
- Funding a cohort of sub-awards to community-based entities nationwide to conduct research to understand and measure the extent to which existing interventions reduce falls and risk factors.
- Developing a secure, dynamic system to house the data collected and evidence developed by sub-awardees.
- Serving as a national focal point for technical assistance that supports the delivery and scaling of effective falls prevention interventions across the aging network.
CMS to hold Medicare Drug Price Negotiation Program listening sessions
The Centers for Medicare & Medicaid Services (CMS) plans to host a series of patient-focused virtual listening sessions for the Medicare Drug Price Negotiation Program. The sessions are intended to provide opportunities for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations. CMS will host 10 Listening Sessions this fall, one for each of the 10 selected drugs:
- Eliquis: Monday, October 30, 12:00 – 1:30 PM EST
- Enbrel: Tuesday, October 31, 12:00 – 1:30 PM EST
- Entresto: Wednesday, November 1, 12:00 – 1:30 PM EST
- Farxiga: Thursday, November 2, 12:00 – 1:30 PM EST
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill: Friday, November 3, 12:00 – 1:30 PM EST
- Imbruvica: Monday, November 6, 12:00 – 1:30 PM EST
- Januvia: Tuesday, November 7, 12:00 – 1:30 PM EST
- Jardiance: Wednesday, November 8, 12:00 – 1:30 PM EST
- Stelara: Tuesday, November 14, 12:00 – 1:30 PM EST
- Xarelto: Wednesday, November 15, 2:00 – 3:30 PM EST
The sessions are open to the public and will be live streamed. Registration is not necessary to view the livestream. Registration by October 2 is required to make a public statement at one or more of the virtual listening sessions. Because there are limited speaking opportunities during the sessions, CMS encourages the public to submit written input by the October 2 deadline, if interested, in response to the 2023 CMS information collection request about selected drugs and evidence about alternative treatments. Submissions can include data on the selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical need and impacts on specific populations as well as the patient/caregiver experience.
KFF issue brief examines what share of nursing facilities might meet CMS proposed staffing standards
On September 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule (CMS 3442-P) that would create new requirements for nurse staffing levels in nursing facilities. An earlier report by the National Academy of Sciences, Engineering, and Medicine (NASEM) raised concerns about low nursing staff levels in nursing facilities and the impact on the quality of care for nursing home residents. In response to the CMS proposed rule, Kaiser Family Foundation has published an issue brief analyzing the percentage and characteristics of facilities that would meet the proposed requirements for the minimum number of registered nurse and nurse aide hours. The analysis does not evaluate facilities’ ability to comply with other proposed requirements, including the requirement to always have a registered nurse on duty 24/7 or the ability to meet the new reporting and assessment requirements due to data limitations. The analysis uses Nursing Home Compare data, which include 14,591 nursing facilities (97% of all facilities, serving 1.17 million or 98% of all residents) that reported staffing levels in August, 2023. KKF found that:
- Among all nursing facilities, fewer than 20% currently could meet the required number of hours for registered nurses and nurse aides, meaning that over 80% of facilities would need to hire nursing staff.
- 90% of for-profit facilities would need to hire additional nursing staff compared with 60% of non-profit and government facilities.
- The percentage of nursing facilities that would meet the requirements in the proposed rule varies from all in Alaska (100%) to nearly none in Louisiana (1%).
Interest parties may submit public comments to CMS on the proposed rule by the November 6 deadline. Additional information about the public comment opportunity is available on the LEAD Coalition Take Action web page until the comment deadline.
ADI releases World Alzheimer’s Report 2023
Alzheimer’s Disease International has released World Alzheimer Report 2023, which focuses on reducing the risk of dementia and offers a global insight into the ways in which dementia risk factors are experienced. The report examines modifiable and non-modifiable risk factors as well as the benefits of lifelong risk reduction. The report highlights global disparities in an individual’s ability and means to mitigate their risk of dementia, and includes a call to action for governments to provide population-based systemic changes to promote risk reduction and the importance of dementia research. For additional insight, watch the archived webinar.
Additional Reads
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- Specific interneurons are important in aging-associated cognitive decline, study finds (read here)
- Decoding the complexity of Alzheimer’s disease (read here)
- Sitting all day increases dementia risk — even if you exercise (read here)
- “Anti-tangle” molecule could aid search for new dementia treatments, say scientists (read here)
- Ten-year plan to fill dementia knowledge gaps (read here)
- Exploring the Association Between Opioid Use Disorder and Alzheimer’s Disease and Dementia Among a National Sample of the U.S. Population (read here)
- Researchers Connect Alzheimer’s-Associated Genetic Variants with Brain Cell Function (read here)
- Researchers discover how a gene only some of us have may protect against neurodegeneration (read here)
- Meet the Two New Biomarker Candidates for Lewy Body Diseases (read here)
- Researchers find success with stem cell therapy in mice model of Alzheimer’s disease (read here)
- How do toxic proteins accumulate in Alzheimer’s and other diseases? (read here)
- Hypertension and Stroke as Mediators of Air Pollution Exposure and Incident Dementia (read here)
- New research reveals link between finger tapping and Alzheimer’s (read here)
- When Faced with Amyloidosis, Human Transplants Die by Necroptosis (read here)
- ‘A Profound Change’: New Guidelines Proposed for Diagnosing Alzheimer’s (read here)
- Mechanisms of phototherapy of Alzheimer’s disease during sleep and wakefulness: the role of the meningeal lymphatics (read here)
- Telecare Cuts Costs, Boosts Quality of Life for Dementia Patients (read here)
- Fundamental process behind memory now captured live (read here)
- Living in a disadvantaged neighborhood affects food choices, weight gain and the microstructure of the brain (read here)
- MEG3 activates necroptosis in human neuron xenografts modeling Alzheimer’s disease (read here)
- Evaluation of the Electronic Clinical Dementia Rating for Dementia Screening (read here)
- CSF Proteomic Panel Better Predicts Decline Than Do Classic AD Biomarkers (read here)
- Navigating the complexities of caregiving for dementia in South Asian communities (read here)
- Could a Breakdown in the Brain’s Networks Allow Infections to Contribute to Alzheimer’s Disease? (read here)
- New link between increased astrocytes in the brain and blood in early Alzheimer’s disease (read here)
- Researchers Create a New Window on Leading Genetic Cause of Alzheimer’s (read here)
- Large amounts of sedentary time linked with higher risk of dementia in older adults (read here)
- PLCγ2 Variants Toggle Microglial Plaque Compactors (read here)
- The High-Wire Act of Caregiving and Saving for Retirement (read here)
- Exercise-Induced Hormone Irisin May Reduce Alzheimer’s Disease Plaque and Tangle Pathology in the Brain (read here)
- Using Focused Ultrasound to Treat Alzheimer’s and Parkinson’s (read here)
- Specialized dementia care in nursing homes linked to better outcomes for residents (read here)
- Poor metabolic health could increase your risk of developing dementia later in life (read here)
- Some US airports strive to make flying more inclusive for those with dementia (read here)
- Health Care Costs Associated With Hospice Use For People With Dementia In The US (read here)
- The dementia tax (read here)
- Customize your dementia clinical trial recruitment materials with OutreachPro! (read here)
- ADscreen: A speech processing-based screening system for automatic identification of patients with Alzheimer’s disease and related dementia (read here)
- Hospital-Diagnosed Infections, Autoimmune Diseases, and Subsequent Dementia Incidence (read here)
- The Power of Food for People with Dementia (read here)
- New perspectives on understanding, preventing and treating vascular dementia (read here)
- Social isolation contributes to brain atrophy and cognitive decline in older adults, study suggests (read here)
- Emerging diagnostics and therapeutics for Alzheimer disease (read here)
- Treatments for AD: towards the right target at the right time (read here)
- Alzheimer’s Is a Terrible Disease—Especially If You’re Black (read here)
- UK researchers 1st to show multiple sclerosis drug can be used as Alzheimer’s therapy (read here)
- Unlocking how the new Alzheimer’s drug lecanemab works (read here)
August, 2023 News
CDC opens Health Brain Resource Center and repository of state and local AD/ADRD Plans
The Centers for Disease Control and Prevention (CDC) has opened its Healthy Brain Resource Center (HBRC), an easy-to-navigate website that helps users find credible public information and materials to support implementing the Healthy Brain Initiative (HBI) Road Map actions. CDC’s Alzheimer’s Disease Program also has compiled and centralized all publicly available state and jurisdiction strategic plans on Alzheimer’s disease and related dementias (ADRD). By having these plans easily accessible, states, jurisdictions, and other organizations interested in ADRD can learn what others are doing, which can foster collaboration and support engagement in priorities for action.
CDC announces new 43 BOLD capacity-building and implementation grant awardees
The Centers for Disease Control and Prevention (CDC) has announced 43 “BOLD Public Health Programs to Address Alzheimer’s Disease and Related Dementias” (CDC-RFA-DP23-0010) grant awardees. This funding is supported by the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act, Public Law 115-406. The award date is September 30. Recipients will use a public health approach to Alzheimer’s Disease and related dementias (ADRD) using CDC’s Healthy Brain Initiative State and Local Public Health Partnerships to Address Dementia: The 2023-2027 Road Map, the Road Map for Indian Country (RM Series), as well as future updates, as guides to expand and improve the response to ADRD in their jurisdictions.
Thirteen Component 1 recipients will be funded for two capacity-building years and three implementation years. During the capacity-building phase, recipients will be creating statewide dementia coalitions and developing or updating ADRD strategic plans for their jurisdictions. During the implementation phase, recipients conduct ADRD activities in line with their strategic plan and the Road Map actions. Thirty Component 2 recipients will be funded for five implementation years to conduct ADRD activities in line with their strategic plan and Road Map actions. All 43 recipients will increase awareness and understanding among the general public (including populations experiencing high burden), providers, and other professionals, about ADRD topics corresponding to primary, secondary, and tertiary prevention. Recipients will address the social determinants of health (SDOH) to achieve health equity goals including but not limited to the improvement of community-clinical linkages among health care systems and existing services, public health agencies, and community-based organizations. For the full list of recipients, along with additional project details as they become available, click here.
CMS announces GUIDE comprehensive dementia care model
On July 31, the Centers for Medicare & Medicaid Services (CMS) announced its Guiding an Improved Dementia Experience (GUIDE) Model — a package of care coordination and management, caregiver education and support, and respite services — which aims to improve the quality of life for people living with dementia, reduce strain on unpaid caregivers, and help people remain in their homes and communities. GUIDE will be tested nationwide from 2024-2032 as a voluntary alternative payment model (APM) through the CMS Center for Medicare and Medicaid Innovation (CMMI). Qualified participating health care providers will deliver comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. Under the GUIDE model, people with dementia and their caregivers will have access to a care navigator who will help them access services and supports, including clinical services and non-clinical services such as meals and transportation through community-based organizations. Prior to CMS releasing the application this autumn, interested organizations are encouraged to submit Letters of Intent to CMS by September 15. Providers eligible to be GUIDE participants are Medicare Part B-enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model. If an applicant cannot meet the GUIDE care delivery requirements alone, they may contract with another Medicare provider/supplier to meet the care delivery requirements. For additional information, see the GUIDE Model Fact Sheet , FAQ, press release, and sign up for the August 10 CMS GUIDE webinar.
CMS extends through September 2027 the Medicaid HCBS mandatory spousal impoverishment provisions
On August 15, the Centers for Medicare & Medicaid Services (CMS) released an informational bulletin notifying states that mandatory financial eligibility rules (spousal impoverishment provisions) for married applicants and beneficiaries eligible for home- and community-based services (HCBS) in Medicaid are extended to September 30, 2027. Under the Medicaid spousal impoverishment provisions, a certain amount of the couple’s combined resources is protected for the spouse living in the community. The extension helps married individuals seek coverage of certain long-term services and supports they need to stay healthy.
NIH releases FY 2025 Professional Judgement Budget and 2023 Scientific Progress Report
- Epidemiology/Population Studies
- Disease Mechanisms
- Diagnosis, Assessment, & Disease Monitoring
- Translational Research & Clinical Interventions
- Dementia Care & Impact of Disease
- Research Resources
ACL awards new Lifespan Respite Care Program grants
BOLD PHCOE Dementia Risk Reduction Summit recordings available
The Alzheimer’s Association BOLD Public Health Center of Excellence (PHCOE) on Dementia Risk Reduction recently held its Risk Reduction Summit at the Centers for Disease Control and Prevention (CDC). The Summit convened public health officials, researchers, and academics to identify what public health agencies at the state, local, and tribal levels can do to address dementia risk factors across the prevention spectrum. All sessions were recorded and now are available to view (YouTube). PDF presentations also are available. For additional information about the Summit or the PHCOE’s work, please contact centerofexcellence@alz.org.
Study defines disparities in memory care
NASEM publishes consensus framework on equity in health and medicine innovation
PCORI seeks applications for research on healthy aging
The Patient-Centered Outcomes Research Institute (PCORI) will open a funding opportunity entitled Healthy Aging: Optimizing Physical and Mental Functioning Across the Aging Continuum on September 6. PCORI will solicit applications for comparative clinical effectiveness research studies on different phases of the aging continuum that aim to achieve one or more of the following goals:
- Maintaining function and independence
- Facilitating chronic disease management
- Supporting individuals with significant functional impairment
- Reducing caregiving burden and improving quality of life
For this reissuance, PCORI especially encourages applications focused on improving the health care and health outcomes for older adults with multiple chronic conditions and those with sensory impairments such as loss of vision or hearing, as well as care models for individuals living with Alzheimer’s Disease and Related Dementias (ADRD). Applications of particular interest are those examining interventions that emphasize caregiver needs as well as those focusing on delivery models that integrate primary and specialty care as well as community-based services. PCORI further encourages applications focused on populations benefiting from a health equity approach, including those who are underserved, underrepresented or historically excluded.
Interested researchers should attend applicant webinar on September 13 and send a Letter of Intent by October 3 by 5 pm (ET). A total of $50 million in funding is available, with up to $12 million for each award.
CMS white paper assesses Innovation Center focus on health equity
Historically, Centers for Medicare & Medicaid Services (CMS) Innovation Center models were not designed explicitly to serve underserved populations, and most evaluations have not focused on health equity-related outcomes. In its 2021 strategy refresh, the Innovation Center prioritized health equity in all of its operations. To support the new goals, a retrospective analysis of model evaluations was conducted to determine the reach of Innovation Center models and assess the degree of and impact of health equity incorporation in model designs and evaluations. This analysis, “Assessing Equity to Drive Health Care Improvements: Learnings from the CMS Innovation Center,” identified means for evaluating health equity impacts and revealed gaps.
The review yielded three primary insights:
- The quality of the race/ethnicity variables in Medicare and Medicaid claims data presents a challenge for understanding whether models reach and enroll underserved individuals.
- Model designs have not always considered needs specific to underserved individuals.
- Model designs that do not prioritize the inclusion of underserved individuals may have small sample sizes for these populations that limits the ability to draw conclusions.
This study provides a foundation for assessing equity in prior health care models and for designing and promoting equitable quality improvement and evaluation.
Additional Reads
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- A review of the neurological imaging techniques in dementia diagnosis (read here)
- Deprescribing efforts failing dementia patients, study finds (read here)
- Dementia and Seizures: What’s the Relationship? (read here)
- LGBTQ+ caregivers of people with dementia face unique stresses that lead to poorer physical and mental health (read here)
- A fitness tracker for brain health: How a headband can identify early signs of Alzheimer’s disease in your sleep (read here)
- ‘Molecular road’ to Alzheimer’s leads to new treatment strategy (read here)
- Does microRNA-132 have therapeutic potential against Alzheimer’s disease? (read here)
- Intermittent Fasting Improves Alzheimer’s Pathology (read here)
- Melatonin and its Derivatives Enhance Long-Term Object Recognition Memory (read here)
- “Viral relicts” in the Genome Could Fuel Neurodegeneration (read here)
- Caution: Living Alone Puts People with Cognitive Decline at Risk (read here)
- Several vaccines associated with reduced risk of Alzheimer’s disease in adults 65 and older (read here)
- AI‐based assessments of speech and language impairments in dementia (read here)
- Long-Term Exposure to Air Pollution Increases Dementia Risk (read here)
- Restoring Helper Cell Function to Fight Alzheimer’s (read here)
- Price of elder care soars as demand increases, baby boomers age (read here)
- Disease severity and mortality in Alzheimer’s disease: an analysis using the U.S. National Alzheimer’s Coordinating Center Uniform Data Set (read here)
- Stanford Medicine-led research identifies gene ‘fingerprint’ for brain aging (read here)
- Opportunities For States To Promote Caregiver Integration For Hospitalized Patients (read here)
- Projected Savings to Canadian Provincial Budgets from Reduced Long-Term Care Home Utilization Due to a Disease-Modifying Alzheimer’s Treatment (read here)
- Does One Copy of the Christchurch ApoE Variant Slow Alzheimer’s? (read here)
- Study links changes in brain immune cells to Alzheimer’s (read here)
- Wanted: Fluid Biomarkers for CAA, ARIA (read here)
- Tau-PET: a window into the future of Alzheimer’s patients (read here)
- Stem Cell Therapy Rescues Symptoms of Alzheimer’s Disease (read here)
- Tiny Brains In a Dish Could Finally Uncover The Long-standing Mysteries of Psychedelics (read here)
- Alzheimer’s gene associated with increased fertility in Amazonian women (read here)
- Paying For Dementia Care That Improves Patient Outcomes, Supports Caregivers, And Saves Money (read here)
- Is ARIA an Inflammatory Reaction to Vascular Amyloid? (read here)
- Associations between air pollution and mental health service use in dementia: a retrospective cohort study (read here)
- Unraveling Alzheimer’s Catalysts as Weavers of Amyloid β Fibrils ~Molecular Mechanism of Accelerated Formation of Amyloid β Fibrils on Neuronal Cell Membranes (read here)
- Major US health systems expect to offer Alzheimer’s drug Leqembi in a few months (read here)
- Why consumer tests for risk of Alzheimer’s have potential downsides (read here)
- Researchers Propose a Data-driven Strategy to Stratify Risk of Progression from Mild Cognitive Impairment to Alzheimer’s disease (read here)
- Cohort LEADS Toward Better Understanding of Sporadic Early Onset AD (read here)
- The Healing Power of Art: Exploring its Therapeutic Benefits in Disease Treatment and Prevention (read here)
- Insulin-like hormones critical for brain plasticity (read here)
- Stress in childhood linked to physical and cognitive problems in older age, according to new study (read here)
- Increased Risk of Dementia Diagnosis, Benzodiazepine Exposure in Seniors with Anxiety (read here)
- Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution (read here)
- Former Sen. Max Baucus: Breakthrough Alzheimer’s drugs are out of reach for many in rural states like Montana (read here)
- The State of Artificial Intelligence and Machine Learning for Diagnosing, Differentiating and Predicting Prognosis in Dementia (read here)
- Diet Rich in Ultra-Processed Foods Can Accelerate Dementia Risk (read here)
- Novel vaccine key to reduce Alzheimer’s impact (read here)
- Minds & eyes: Study shows dementia more common in older adults with vision issues (read here)
- New policy research unit to improve dementia prevention, diagnosis and care (read here)
- Dementia care navigation: Building toward a common definition, key principles, and outcomes (read here)
- Estimating presymptomatic episodic memory impairment using simple hand movement tests: A cross‐sectional study of a large sample of older adults (read here)
- New Ultrasound Therapy Could Help Treat Alzheimer’s, Cancer (read here)
- TRIM11 protects against tauopathies and is down-regulated in Alzheimer’s disease (read here)
July, 2023 News
Senate HELP Committee reports out bipartisan pandemic prevention bill
On July 20, the Senate Health, Education, Labor, and Pensions (HELP) Committee, favorably reported out the bipartisan Pandemic and All-Hazards Preparedness and Response Act (PAHPA; S.2333, bill text with adopted amendments from Senator Hickenlooper and Senator Budd) on a 17-3 vote. PAHPA strengthens the nation’s biosecurity and biosafety, addresses the needs of at-risk populations, strengthens public health communications, coordinates research relating to long COVID, supports innovative technologies like wastewater surveillance, and reauthorizes the medical countermeasure priority review voucher program (see the legislation’s section-by-section details). Specifically, the Pandemics and All-hazards Preparedness and Response Act includes provisions to:
- Reauthorize core public health preparedness programs including the Public Health Emergency Preparedness cooperative agreements, the Hospital Preparedness Program, the Epidemiology Laboratory Capacity cooperative agreements, the Biomedical Advanced Research and Development Agency and the Strategic National Stockpile.
- Expand the representation of seniors and people with disabilities who advise the federal government on emergency preparedness.
- Require states to create crisis standards of care that prohibit discrimination of older adults and people with disabilities during disasters and emergencies.
- Promote better public health data-sharing during an outbreak.
- Establish a no-fault reporting system for laboratories to create a safety feedback loop.
- Support research and surge capacity during a pandemic.
- Support ongoing wastewater surveillance efforts.
- Examine the potential vulnerabilities to health security posed by artificial intelligence.
- Ensure that manufacturers communicate circumstances that may result in drug shortages and provide information to FDA in order to avoid potential shortages.
- Reauthorize the medical countermeasure priority review program.
Phase 3 confirmatory study shows donanemab significantly slows cognitive and functional decline early symptomatic Alzheimer’s disease
On July 17, Eli Lilly presented full results (see slides) from the Phase 3 TRAILBLAZER-ALZ 2 study (NCT04437511) showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease (either mild cognitive impairment or mild dementia). The data were shared at the 2023 Alzheimer’s Association International Conference (see the Alzheimer’s Association statement) and simultaneously published in the Journal of the American Medical Association (Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial). Lilly previously announced that donanemab met the primary and all cognitive and functional secondary endpoints in the Phase 3 study. Submission to the U.S. FDA for traditional approval was completed last quarter with regulatory action expected by the end of the year. Submissions to other global regulators are currently underway, and the majority will be completed by year end.
Participants in TRAILBLAZER-ALZ 2 were stratified by their level of tau, a predictive biomarker for disease progression, into either a low-medium tau group (sometimes referred to as intermediate tau) or a high tau group, which represented a later pathological stage of disease progression. All participants were then assessed over 18 months using scales that measure both cognition and function, including the integrated Alzheimer’s Disease Rating Scale (iADRS) and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). As previously reported, among participants with low-medium levels of tau (n=1182), donanemab treatment significantly slowed decline by 35% on iADRS and 36% on CDR-SB. Among all amyloid-positive early symptomatic AD study participants (n=1736), treatment with donanemab significantly slowed decline by 22% on iADRS and 29% on CDR-SB.
PCHETA reintroduced in Senate
Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) recently re-introduced the Palliative Care and Hospice Education and Training Act (PCHETA; S. 2243), bipartisan legislation to bolster the palliative care and hospice workforce and meet the growing need for care by investing in training, education, and research. Palliative and hospice care focus on relieving patients’ suffering from serious illnesses and working to improve their quality of life. Medical research shows that palliative and hospice care have been associated with enhanced quality of life for patients, reduced hospital expenditures and lengths of stay, and longer patient survival time. PCHETA would help ensure the necessary workforce to treat patients and improve the quality of life for millions of Americans facing serious illness by focusing on three key areas:
- Workforce Training – Supports the training of interdisciplinary health professionals, including physicians, nurses, social workers, physician assistants, chaplains, and others in palliative care; supports the training and retraining of faculty; and provides students with clinical training in appropriate sites of care.
- Education and Awareness – Shares research and information with patients, families, and health professionals about the benefits of palliative care and the services that are available to support patients with serious or life-threatening illnesses.
- Enhanced Research – Directs the Department of Health and Human Services (HHS) to use existing authorities and funds to expand palliative care research to advance clinical practice and improve care delivery for patients with a serious or life-threatening illness.
For additional information, read the PCHETA one-pager and the Palliative Care At-a-Glance factsheet.
RAISE Family Caregiving Advisory Council to start second term
The RAISE Family Caregiving Advisory Council — established by the Recognize, Assist, Include, Support, and Engage (RAISE) Family Caregivers Act — is charged with providing recommendations on effective models of family caregiving and support to family caregivers as well as improving coordination across federal government programs. On June 27, from 2:00 to 4:30 p.m. ET, the Administration for Community Living (ACL) will host a virtual joint meeting (public meeting access will begin at approximately 1:55 p.m. ET) to kick-off the new RAISE Family Caregiving Advisory Council and the Advisory Council to Support Grandparents Raising Grandchildren (SGRG). During the joint meeting, ACL will introduce and swear-in new council members for three-year terms. Additionally, federal leaders and partners will deliver presentations about the way forward for the work of the councils, and preview the next joint advisory council meeting (September 19). All information for the July 27 meeting, including an agenda, will be posted on the RAISE and SGRG webpages in advance of the meeting. Contact RAISE.mail@acl.hhs.gov with any questions.
FDA gives traditional approval to Leqembi, CMS offers broader coverage
On July 6, the U.S. Food and Drug Administration (FDA) converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. For details, read the full FDA statement and the full FDA-approved label, which contained a boxed warning. Please also read the full statement from Eisai and Biogen, which jointly developed Leqembi.
Immediately following FDA’s decision, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that it was broadening coverage for Leqembi. A CMS-facilitated registry is open for clinicians to access here. According to CMS
To receive Medicare coverage, people will need to: 1) be enrolled in Medicare, 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain, and 3) have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. Clinicians participating in the registry will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.
For additional information, read the full CMS statement along with the provider (download here) and consumer fact sheets (download here), and watch the short video demonstrating how health providers should enroll patients in the CMS registry.
The LEAD Coalition extends its gratitude to the FDA for its rigorous scientific examination of the evidence along with its careful consideration of stakeholder input, particularly regarding the necessity of addressing the high unmet need for treatments to slow the progression of Alzheimer’s disease. The LEAD Coalition commends CMS for listening and responding to the unified voice of the dementia advocacy community — including people facing Alzheimer’s disease, scientists and health care providers, LEAD Coalition member and allied organizations, bipartisan Members of Congress and state attorneys general, and others — by moving a great deal closer toward coverage-to-label over the past two years. The LEAD Coalition remains committed to working with CMS and other payers to lower and remove barriers to access for all FDA-approved treatments to prevent, slow, stop, or otherwise treat Alzheimer’s disease and other causes of dementia.
Treat and Reduce Obesity Act reintroduced
Senators Tom Carper (D-DE) and Bill Cassidy (R-LA) and Representatives Raul Ruiz (D-CA) and Brad Wenstrup (R-OH) have reintroduced the Treat and Reduce Obesity Act (TROA; bill text). According to the Centers for Disease Control and Prevention, diseases associated with obesity are the leading causes of preventable death in the U.S. The legislation would work to prevent these diseases through expanded coverage of new health care specialists and chronic weight management medications for Medicare beneficiaries. The bill also would work to mitigate the obesity epidemic by providing regular screenings.
Researchers publish first-ever county-level prevalence estimates for Alzheimer’s disease dementia
Rush University researchers have published the first-ever Alzheimer’s disease dementia prevalence estimates for each of the United States’ 3,142 counties. The study utilized cognitive data from the Chicago Health and Aging Project, a population-based study, and combined it with the National Center for Health Statistics 2020 bridged-race population estimates to determine the prevalence of Alzheimer’s disease in adults age 65 or older. The highest rates of prevalence were shown to occur in the East and Southeast US in states such as Maryland (12.9%), New York (12.7%), and Mississippi (12.5%). For counties with a population of 10,000 or more individuals age 65 or older, they estimate the highest Alzheimer’s prevalence rates were:
- Miami-Dade County, Fla. (16.6%)
Baltimore City, Md. (16.6%)
Bronx County, N.Y. (16.6%)
Prince George’s County, Md. (16.1%)
Hinds County, Miss. (15.5%)
Orleans Parish, La. (15.4%)
Dougherty County, Ga. (15.3%)
Orangeburg County, S.C. (15.2%)
Imperial County, Calif. (15.0%)
El Paso County, Texas (15.0%)
A combination of specific demographic characteristics may explain the higher prevalence in these counties, including older average age and higher percentages of Black and Hispanic residents. For example, among residents age 65 years and older of the Bronx County in New York, 14% were 85 and older (compared to a national average of 12% of people 65 and older), 30.1% were African Americans and 46.9% were Hispanic Americans (compared to national averages of 9.4% and 8.8%, respectively). The state- and county-specific estimates could help public health officials to understand the burden of disease (e.g., demand for caregiver counseling and institutional care) and develop strategies for identifying and caring for people with Alzheimer’s disease dementia. For additional details, see this interactive county-level map.
AARP’s GCBH issues recommendations for promoting brain health globally
AARP and the Global Council on Brain Health (GCBH) have released a report, “Building Better Brain Health for All People: GCBH Recommendations on Removing Barriers and Improving Opportunities Around the World,” which explores challenges to brain health faced by different communities around the world and offers recommendations to address such challenges. Within every country, public policies, political systems, economic conditions, social norms, and environmental factors influence health and wellness for better or worse. Discrimination based on age, race, ethnicity, gender and gender identity/roles, sexual orientation, national origin, caste, disabilities (visible as well as invisible), and genetic forms of neurological diseases contributes to poor physical and mental health in many societies. Barriers rooted in government policy, health care, institutional values, professional practice, and culture itself all may stand in the way of optimal brain health. To address these factors, the GCBH took a multifaceted approach, featuring nearly 40 recommendations, grounded in the latest scientific research and informed by the lived experience of individuals with cognitive loss. Innovations in policy, research, technology, community engagement, infrastructure, environmental design, and family supports are discussed in the report as parts of the answer.
Coalition launches action plans to improve nursing home quality
The national Moving Forward Nursing Home Quality Coalition recently released nine detailed action plans to improve the quality of life for residents and quality of work for staff in nursing homes. Each plan outlines specific steps to advance nursing home quality improvement:
- Creating care planning and measurement tools for residents’ goals, preferences & priorities
- Piloting best practices to strengthen nursing home resident councils
- Increasing CNA compensation through state quality incentive payment programs
- Developing a Certified Nursing Assistant (CNA) career pathway model using an established apprenticeship program framework to increase interest in the profession
- Creating a targeted recertification survey to improve overall state survey agency capacity
- Developing enhanced state surveyor trainings on person-centered care
- Increasing nursing home ownership data transparency
- Developing a health information technology guide to help nursing home operators navigate new regulations and digital capabilities
- Incentivizing converting traditional nursing homes with less privacy to smaller households with private rooms
Comprised of more than 120 individuals and organizations focused on nursing home reform, the Coalition launched in September 2022 to act on the National Academies of Sciences, Engineering, and Medicine report, The National Imperative to Improve Nursing Home Quality. The Coalition is funded by The John A. Hartford Foundation, and draws on leadership from LeadingAge, the Institute for Healthcare Improvement, other national organizations and advisors.
Additional Reads
- As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up (read here)
- Dementia becomes an emergency 1.4 million times a year (read here)
- Dementia Linked With Depression in Early and Middle Life (read here)
- Sleep Architecture, Obstructive Sleep Apnea, and Cognitive Function in Adults (read here)
- Oral Tau Inhibitor Continues to Show Promise in Alzheimer’s (read here)
- Mason research on supportive decision making could help people living with dementia (read here)
- Living in disadvantaged neighborhoods linked to higher dementia risk, study finds (read here)
- Detecting Alzheimer’s Disease: Older Adults’ Experiences with Cognitive Screening & Blood Biomarker Testing (read here)
- Intergenerational Trauma Among Elders (read here)
- Bodybuilding Supplement May Help Stave off Alzheimer’s (read here)
- These proteins could predict dementia risk decades before symptoms, new study suggests (read here)
- Lewy body disease can be detected before symptoms (read here)
- A New Way Of Diagnosing Alzheimer’s Disease Is On The Horizon (read here)
- Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial (read here)
- Promoting Healthy Aging: Public Health as a Leader for Reducing Dementia Risk (read here)
- New study shows anti-inflammatory drugs as a promising target for Alzheimer’s disease (read here)
- CRISPR/Gene Editing Technology Creates New Treatment Possibilities for Alzheimer’s Disease (read here)
- Lifestyle Enrichment in Later Life and Its Association With Dementia Risk (read here)
- Artificial intelligence tool that counts brain lesions in seconds (read here)
- A Novel Biosensor for Detecting Neurodegenerative Disease Proteins (read here)
- Biomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials (read here)
- Lecanemab to be Tested in Preclinical Alzheimer Disease (read here)
- Dementia Treatment: An Unmet Need (read here)
- The link between hearing loss and dementia (read here)
- Artificial Intelligence Is Everywhere You Look in Dementia Research (read here)
- This certification, developed with the Alzheimer’s Association, recognizes assisted living communities that use best practices for residents with dementia. (read here)
- Fast-spiking parvalbumin-positive interneurons in brain physiology and Alzheimer’s disease (read here)
- We finally have new Alzheimer’s drugs. How do we decide who gets them? (read here)
- A new era for Alzheimer’s treatment begins (read here)
- Taking good care of your teeth may be good for your brain, study suggests (read here)
- Fluctuating levels of cholesterol and triglycerides linked to increased risk of dementia (read here)
- Proteomics of brain, CSF, and plasma identifies molecular signatures for distinguishing sporadic and genetic Alzheimer’s disease (read here)
- Study suggests resistance training can prevent or delay Alzheimer’s disease (read here)
- Mortality and Discharge Location of Intensive Care Patients With Alzheimer Disease and Related Dementia (read here)
- Dementia is not the end of learning (read here)
- How a Swedish start-up reignited the search for an Alzheimer’s drug (read here)
- Repurposing Artificial Intelligence Tools for Disease Modeling: Case Study of Face Recognition Deficits in Neurodegenerative Diseases. (read here)
June, 2023 News
LEAD Coalition renews call for Congress to boost FY 2024 dementia funding
Healthy Brain Initiative releases new HBI Roadmap
On June 29, the fourth edition of the Healthy Brain Initiative (HBI) Road Map was released (see: full document and executive summary). “Healthy Brain Initiative: State and Local Road Map for Public Health, 2023-2027” provides public health officials nationwide with a set of strategies to promote brain health and improve the quality of life for people living with dementia and their caregivers. LEAD Coalition executive director Ian Kremer, along with representative of numerous LEAD Coalition member and allied organizations, served on the Leadership Committee to help develop this new edition of the HBI Road Map. The Alzheimer’s Association and the Centers for Disease Control and Prevention (CDC) jointly have led efforts to develop the evolving Healthy Brain Initiative Road Map Series for over 15 years.
- Strengthening partnerships and policies
- Measuring, evaluating, and utilizing data
- Building a diverse and skilled workforce
- Engaging and educating the public
Data and examples are included throughout to help state and local health departments achieve outcomes both individually and collectively. This Road Map advances equity by fully integrating brain health and caregiving into state and local public health practice and addressing social determinants of health that impact brain health across the life course. The Road Map provides public health practitioners with opportunities to reach diverse communities and reduce health disparities. For additional information, please attend the LEAD Coalition’s August 12 meeting, which will feature a guest presentation by the CDC and Alzheimer’s Association.
Roche’s tTau and Abeta42 Alzheimer’s assays receive FDA clearance
New report addresses healthy aging indicators
An analysis, “Indicators of Healthy Aging: A Guide to Explore Healthy Aging Data through Community Health Improvement,” conducted by the National Association of County and City Health Officials (NACCHO), found that most Community Health Improvement Plans (CHIPs) include priorities that, while not specifically addressing older adults, could be adapted for healthy aging programs. These priorities include chronic diseases, including heart disease, diabetes, stroke, and cancer, as well as substance use, depression, and other mental health conditions. To develop and strengthen age-friendly public health systems, a more comprehensive set of healthy aging indicators is needed to help health departments and community partners at the local, state, tribal, and territorial levels measure and identify population-level health disparities and inequities. Additionally, Community Health Improvement (CHI) partners need a robust, unified source of secondary data that aligns with healthy aging indicators to inform strategic and action planning.
This guide, developed by Trust for America’s Health and the National Association of County and City Health Officials (NACCHO) and with funding from The John A. Hartford Foundation, is designed to augment NACCHO’s Mobilizing for Action through Planning and Partnerships (MAPP) framework. MAPP is the most widely used CHI framework among governmental public health departments and, increasingly, community-based organizations, nonprofit hospital systems, and community health centers that lead or engage in CHI processes. This also serves as a resource for health departments seeking to attain Age-Friendly Public Health Systems (AFPHS) recognition.
Unanimous FDA advisory committee finds clinical benefit of lecanemab in treating Alzheimers disease
The Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) met on June 9 (FDA–2023–N–1114) to discuss supplemental biologics license application (sBLA) 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of early Alzheimer’s disease. This product was approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) for the treatment of Alzheimer’s disease. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The PCNS advisory committee discussed the confirmatory study, BAN2401–G000–301 (see: New England Journal of Medicine publication of Clarity AD study results), conducted to fulfill post-marketing requirement 4384–1 detailed in the January 6, 2023, approval letter. On the sole voting question, the PCNS advisory committee unanimously found that the Phase 3 Clarity AD study verified lecanemab’s clinical benefit.
For additional information, watch the recorded meeting webcast, review meeting background materials posted by the FDA, read the written public comments, and read the Eisai press statement. The PDUFA target action date for this sBLA is July 6.
LEAD Coalition urges CMS to adopt geriatrics quality measures
Over 240 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Centers for Medicare and Medicaid Services (CMS) expressing strong support for inclusion of the Geriatrics Hospital Measure and the Geriatrics Surgical Measure in the CMS Hospital Inpatient Quality Reporting (IQR) Program (proposed rule CMS-1785-P). Developed by the American College of Surgeons (ACS), the Institute for Healthcare Improvement (IHI), and the American College of Emergency Physicians (ACEP), these measures are designed to help build a better, safer, more age-friendly environment for geriatric hospital patients and will help patients and caregivers know where to get high-quality care that is in line with their values. These measures are a critical piece in optimizing care for older patients by using a holistic approach to create a quality program that better serves the needs of Medicare beneficiaries, especially those living with dementia. Read the full LEAD Coalition letter.
Expert panel calls for urgent policy changes to address inequitable access to Alzheimer’s drugs
An expert working group convened by the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and LuMind IDSC Foundation, has issued an advisory and consensus statement on criteria for access for adults with Down Syndrome (DS) to Alzheimer’s disease therapeutics (read the full report). The advisory follows a painstaking review of equity challenges faced by adults with DS with accessing the new class of anti-amyloid drug for mild cognitive impairment and early Alzheimer’s dementia. Adults with DS have an estimated lifetime risk of up to 90% for Alzheimer’s disease, which contributes to over 70% of their deaths. Adults with DS will face multiple years delayed access to these disease modifying treatments compared to other at-risk populations, because of exclusionary state prescribing authorization criteria (see table). Without urgency in altering these criteria, a generation of aging adults with DS potentially will be deprived of access to new treatments.
To shorten the time for access and to avoid delay in treatment, the working group recommends access through two actions: states and other payers should adopt the proposed DS-focused equivalency criteria as soon as possible, and Phase 4 clinical trials in adults with DS should be undertaken with similar urgency so that clinicians gain relevant information on the safety of this class of drugs for these atypical patients. The working group recommends a series of wording changes to reflect equivalencies in the prescribing criteria, offers substantiation for such changes, and calls upon relevant organizations to provide education to prescribers, and for professional associations to issue protocols for guiding prescribers in the use of this class of Alzheimer’s disease drugs.
Bipartisan legislation seeks to improve diversity in all NIH-funded trials
U.S. Senators Bob Menendez (D-N.J.) and Susan Collins (R-Maine), along with Representatives Robin Kelly (D-Ill.-02) and Brian Fitzpatrick (R-Pa.-01), recently introduced bipartisan, bicameral legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. The NIH Clinical Trial Diversity Act (S.1701/H.R.3503) builds upon the NIH’s current policies to enhance the inclusion of women, racially and ethnically diverse individuals and people of all ages in all NIH-funded trials. The NIH Clinical Trial Diversity Act would:
- Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan;
- Ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow ups, phone participation, weekend hours) to increase participation of underrepresented populations;
- Launch a public awareness campaign across federal agencies related to research participation opportunities.
President appoints Dr. Mandy Cohen as CDC Director
President Biden is appointing Dr. Mandy Cohen, an internal medicine physician, as Director of the Centers for Disease Control and Prevention (CDC). Under current law (which will change in 2025), the position does not require Senate confirmation. Dr. Cohen currently is Executive Vice President at Aledade and CEO of Aledade Care Solution, which helps independent primary care practices, health centers, and clinics deliver better care to their patients and thrive in value-based care. Previously, Dr. Cohen had served as Secretary of North Carolina’s Department of Health and Human Services. She also was Chief Operating Officer and Chief of Staff of the Centers for Medicare and Medicaid Services (CMS), and served as Acting-Director of the Center for Consumer Information and Insurance Oversight (CCIIO). Dr. Cohen was involved in many aspects of the Affordable Care Act policy development and implementation, including the expansion of coverage, insurance protections, and new provider payment models. A graduate of Cornell University, Dr. Cohen received her medical degree from Yale School of Medicine and a Master’s in Public Health from the Harvard School of Public Health. She trained in internal medicine at Massachusetts General Hospital. For analysis, click here.
LEAD Coalition joins wider health advocacy community in urging confirmation of NIH Director nominee
The LEAD Coalition joined 114 organizations in a letter to Senate leadership urging swift confirmation of President Biden’s nominee, Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH). Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Dr. Bertagnolli currently is Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director.
Issue brief proposes HCBS equity framework
In recent decades, long-term care has shifted from institutional settings to home and community-integrated settings. While access to home and community-based services (HCBS) has been increasing, systemic inequalities due to racism, sexism, ageism, classism, and other factors have led to large disparities in HCBS for diverse communities. Justice in Aging has published an issue brief, “An Equity Framework for Evaluating and Improving Medicaid Home and Community Based Services,” which evaluates ways the current organization of HCBS can contribute to inequities. The issue brief examines program design, provider availability, awareness of HCBS, implicit bias in services, and provision of HCBS. For each one of these domains, the issue brief provides case studies to help explain why the current policies lead to inequities. Additionally, the issue brief outline specific policies that should be reviewed in order to improve overall equity in HCBS programs.
Additional Reads
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- International Research Consortium Urges Scientists to Re-Think What Causes Alzheimer’s and Other Dementias (read here)
- Higher levels of lean muscle may protect against Alzheimer’s disease (read here)
- AI tool could speed up dementia diagnosis (read here)
- Menopausal hormone therapy and dementia: nationwide, nested case-control study (read here)
He Has Serious Dementia. Courts Are Still Waiting to Try Him for Murder. (read here)
Shorter Telomeres Point to Increased Alzheimer’s Risk (read here) - Understanding the value of secondary research data (read here)
- Changes in Human Microbiome Precede Alzheimer’s Cognitive Declines (read here)
- Blood condition linked to protection against Alzheimer’s (read here)
- Researchers show the importance of the liver-brain axis in Alzheimer’s disease (read here)
- Galectin-3 activates spinal microglia to induce inflammatory nociception in wild type but not in mice modelling Alzheimer’s disease (read here)
- Federal Data for Conducting Patient-centered Outcomes Research on Economic Outcomes (read here)
- A Closer Look at Hearing Loss, Dementia, and Stigma (read here)
- Abnormalities in neurodevelopment could lay the foundations for Alzheimer’s disease (read here)
- Ultra small molecule as a new target for Alzheimer’s disease? (read here)
- You’ll Soon Be Able to Get a Blood Test for Alzheimer’s (read here)
- VA researcher helping to change the future of Alzheimer’s Disease (read here)
- How Hospice Eligibility Criteria Can Adversely Affect Dementia Patients (read here)
- Altered gut bacteria may be early sign of Alzheimer’s disease (read here)
- Fluorogenic probe to detect enzyme linked to early stage of Alzheimer’s (read here)
- Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force (read here)
- AI helps show how the brain’s fluids flow (read here)
- Significant correlation found between vitreous human biomarkers and Alzheimer’s disease (read here)
- Brain waves may predict cognitive impairment in Parkinson’s disease (read here)
- Excessive alcohol consumption may accelerate Alzheimer’s disease progression (read here)
- UC Irvine neuroscientists develop ‘meta-cell’ to move Alzheimer’s fight forward (read here)
- Confronting aging: How LGBTQ+ seniors can tackle their special caregiving challenges (read here)
- Not covering emerging Alzheimer’s drugs could cost Medicare billions: study (read here)
- Dysesthesia and Depression in Undiagnosed Alzheimer’s Disease (read here)
- ArhGAP11A mediates amyloid-β generation and neuropathology in an Alzheimer’s disease-like mouse model (read here)
- Drawing, making music and writing poetry can support healing and bring more humanity to health care in US hospitals (read here)
- Supreme Court clears way for family of Medicaid recipient to sue state-owned nursing home (read here)
- Genetic protection from early-onset familial Alzheimer’s disease (read here)
- Researchers to Explore Potential of New Treatment Against Vascular Dementia (read here)
- Revealing How Blood Triggers Brain Disease (read here)
- Scientists Achieve Groundbreaking First by Applying Artificial Intelligence for Early Risk Forecasting of Alzheimer’s Disease (read here)
- A chance observation finds potential hearing biomarker for Alzheimer’s disease (read here)
- Improvement of retinal function in Alzheimer disease-associated retinopathy by dietary lysophosphatidylcholine-EPA/DHA (read here)
- Dementia Care Is Widespread In US Nursing Homes; Facilities With The Most Dementia Patients May Offer Better Care (read here)
- Improving the health and well-being of sexual and gender minority older adults (read here)
- The role of peripheral inflammatory insults in Alzheimer’s disease: a review and research roadmap (read here)
- Poorly insulated nerve cells promote Alzheimer’s disease in old age (read here)
- Alzheimer’s Disease Plasma Biomarker and Pathogenesis Contribute to Postoperative Delirium-like Behavior in Rodents (read here)
- Unweaving the microscopic threads of Alzheimer’s tapestry: single-cell dissection of vascular changes across six brain regions (read here)
- Being socially active in mid-late life linked to 30-50% lower dementia risk (read here)
- A Novel Blood Serum Assay to Diagnose Neurodegenerative Diseases (read here)
- Expanding Access to Alzheimer’s Care & Treatment (watch here)
May, 2023 News
President nominates Dr. Monica Bertagnolli as NIH Director
President Biden is nominating Dr. Monica Bertagnolli to serve as Director of the National Institutes of Health (NIH). Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Dr. Bertagnolli currently is Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director. Previously, she served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. Dr. Bertagnolli is a member of the National Academy of Medicine, a past president and chair of the board of directors of the American Society of Clinical Oncology, and has served on the board of directors of the American Cancer Society and the Prevent Cancer Foundation. For analysis, click here.
FDA approves first treatment for agitation symptoms associated with dementia due to Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.
According to the FDA:
The recommended starting dosage for the treatment of agitation associated with dementia due to Alzheimer’s disease is 0.5 mg taken once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily. The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.
The most common side effects among patients with agitation associated with dementia due to Alzheimer’s disease include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (both somnolence and insomnia). Rexulti will retain the Boxed Warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The sNDA submission, from sponsors Otsuka and Lundbeck, was based on data generated from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with agitation associated with dementia due to Alzheimer’s disease. See the sponsors’ full press release here. Please read Full Prescribing Information, including Boxed Warning, and Medication Guide.
CMS updates nursing home visitation guidance for COVID-19
CMS releases 2023 SSI and spousal impoverishment standards
NIA launches updated AD/ADRD Research Implementation Milestones database
NIA has released an enhanced database for tracking of Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) Research Implementation Milestones. These milestones represent a research framework detailing specific steps and success criteria towards achieving the goal of the National Plan to Address Alzheimer’s Disease. Spanning basic, translational, clinical, and health services research, the 204 current milestones were developed based on recommendations from over 350 leading academic and industry experts, innovators and public advocates participating at strategic research planning summits. Users can browse the milestones by Research Areas and further refine by more targeted Research Implementation Areas. For each milestone, users will find success criteria and the projected timeline, along with updated information on progress and achievements, including funding initiatives, research programs and resources, and highlights.
NAPA advisory council examines pathways to new clinical treatments and comprehensive dementia care
New report addresses nursing home oversight
Phase 3 study top line results show donanemab significantly slows cognitive and functional decline
For additional information, see this AlzForum backgrounder on donanemab development, along with news coverage here and here.
Bipartisan group of 26 state attorneys general call on Medicare to cover new Alzheimer’s treatments
Led by Attorneys General Gentner Drummond (R-OK) and Keith Ellison (D-MN), a bipartisan group representing nearly half the states and territories have written to U.S. Health & Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging that “CMS provide full and unrestricted Medicare coverage for FDA-approved Alzheimer’s treatments consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries.” (Read the full letter.) The letter from these attorneys general comes amid mounting bipartisan efforts in the U.S. House and Senate to press CMS to reconsider its national coverage determination (NCD) for FDA-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N).
Additional Reads
- Understanding cognitive decline among elderly with Dementia using the “Heart-to-Brain Connection” (read here)
- Research reveals clues to why immune cells seem to cause brain damage (read here)
- Agitation in Alzheimer Dementia: Progress for an Age-Old Problem (read here)
- Human microglia show unique transcriptional changes in Alzheimer’s disease (read here)
- Does “Good” Cholesterol Increase Your Risk of Alzheimer’s? (read here)
- New information on the development of Alzheimer’s disease – Study reveals a possible cause of inflammation (read here)
- New UCI-led research shows people who live to be 90+ with superior thinking skills are resilient to Alzheimer’s pathology in their brains (read here)
- A lifetime of racism makes Alzheimer’s more prevalent in Black Americans (read here)
- UMD Study Finds Brain Connectivity, Memory Improves in Older Adults After Walking (read here)
- Exercise seems to protect against major brain hemorrhage (read here)
- Recurrent Brain Trauma May Increase Alzheimer’s Risk (read here)
- Association of BCG Vaccine Treatment With Death and Dementia in Patients With Non–Muscle-Invasive Bladder Cancer (read here)
- Time for Dementia: Quantitative evaluation of a dementia education programme for healthcare students (read here)
- Social participation and risk of developing dementia (read here)
- Study: Blood Vessel Damage Could Be an Alzheimer’s Driver (read here)
- 40 Hz vibrations reduce Alzheimer’s pathology, symptoms in mouse models (read here)
- Towards a future where Alzheimer’s disease pathology is stopped before the onset of dementia (read here)
- Study of mouse neurons uncovers novel therapeutic role of removing a genetic variant in the treatment of Alzheimer’s disease (read here)
- Equity across the life course matters for brain health (read here)
- Hi-Res Spatial Proteomics Uncovers Aspects of Alzheimer’s Disease Pathology (read here)
- Dementia study shows how toxic proteins spread (read here)
- Effects of physical exercise on physical function in older adults in residential care: a systematic review and network meta-analysis of randomised controlled trials (read here)
- Inhaling menthol improves cognitive function in Alzheimer’s disease (read here)
- The Mother Who Changed: A Story of Dementia (read here)
- NIH researchers identify large genetic changes that contribute to dementia risk (read here)
- A special omega-3 fatty acid lipid will change how we look at the developing and ageing brain, Duke-NUS researchers find (read here)
- Rochelle Walensky exits as CDC chief (read here)
- Association between chronic pain and risk of incident dementia: findings from a prospective cohort (read here)
- Passing the sniff test: Can we train our brain to boost smell and memory? (read here)
- Regular internet use may be linked to lower dementia risk in older adults, study says (read here)
- Deep sleep may mitigate Alzheimer’s memory loss, Berkeley research shows (read here)
- Dementia and self-harm: why it’s crucial to support patients in first year after diagnosis (read here)
- Prioritising dementia at the G7 (read here)
- Air Pollution May Increase Risk of Dementia, Complicated by Genetics (read here)
- Stress increases Alzheimer’s risk in female mice but not males (read here)
- Medicare’s ‘Coverage With Evidence Development’: A Barrier To Patient Access And Innovation (read here)
- Upregulation of extracellular proteins in a mouse model of Alzheimer’s disease (read here)
- Sleep deprivation exacerbates microglial reactivity and Aβ deposition in a TREM2-dependent manner in mice (read here)
- The structural and social determinants of Alzheimer’s disease related dementias (read here)
April, 2023 News
FDA advisory committee concludes that brexpiprazole for Alzheimer’s dementia agitation has a positive benefit-risk profile
On April 14, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee held a joint meeting to discuss supplemental new drug application (sNDA) 205422 s009, efficacy supplement for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceuticals and Lundbeck, for the proposed treatment of agitation associated with Alzheimer’s dementia (AAD). The joint advisory committee voted 9-1 that “the Applicant provided sufficient data to allow identification of a population in whom the benefits of treating agitation associated with Alzheimer’s dementia with brexpiprazole outweigh its risks” (view meeting materials and the archived meeting webcast). FDA has assigned the sNDA priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10.
Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (reported in approximately 45 percent of patients with Alzheimer’s dementia) and has a large impact on quality of life for the people living with AAD, family members, and caregivers. Agitation covers a large group of behaviors, and it is an excessive manifestation of “normal” human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting. Brexpiprazole, an antipsychotic medication approved in 2015 by the FDA as adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood. The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 (NCT01862640) demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213 (NCT03548584), treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
NIH seeks proposals for real-world data platform to advance dementia research
The National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) have issued a request for applications to develop the Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (RWDP). The NIA will fund a 6-year, up to US$300 million project to develop the RWDP, which will represent 70–90% of the US population (including up to 80% of people living with dementia). The RWDP will help researchers access and analyze health data in a secure cloud computing environment, and recruit from a more diverse pool of individuals. The RWDP also will support collaboration among health care and community health providers to develop and facilitate innovative methods for scalable digital, decentralized, pragmatic, and clinical trials. For additional perspective, read the NIA blog and click here.
Lecanemab OLE shows benefits even after treatment discontinuation
Recently published research has demonstrated that Alzheimer’s patients who take LEQEMBI™ (lecanemab-irmb) retain treatment benefits even after discontinuing the medication. The open label extension (OLE) study included 350 patients with mild to moderate Alzheimer’s disease who had taken LEQEMBI™ for a minimum of six months. The patients were divided into two groups; one group continued taking the drug, and the other group stopped. After six months, the discontinuation group showed no significant decline in cognitive function compared to the continuation group. Further research is needed to confirm these findings and to determine the optimal duration of treatment.
NAPA Dementia Nomenclature Initiative webpage launched
CMS issues 2024 Medicare Advantage and Part D Final Rule
CMS Medicare-Medicaid Coordination Office submits report to Congress
President issues executive order on caregiving
Non-drug Alzheimer’s interventions are effective and cost-effective
While new drugs to treat Alzheimer’s disease tend to receive the most public attention, many well-researched ways to care for people with dementia don’t involve medication. A new study by Brown University researchers compared the cost-effectiveness of four non-drug interventions to the usual care received by people with dementia and found that the care interventions resulted in a better quality of life and saved money. The study’s computer simulation model showed that the care interventions saved between $2,800 and $13,000 in societal costs, depending on the type of intervention, and all reduced nursing home admissions and improved quality of life compared to usual care. In addition to finding that the interventions were cost-effective from a societal perspective, the researchers found the interventions involved little to no additional cost for health care payers. Based on the study findings, the authors concluded that health insurance policies should find ways to incentivize providers and health systems to implement nonpharmacological interventions.
CVS Health to launch home-based care program for older adults
CVS Health has announced plans to improve home-based care for older adults who have been discharged from an acute care setting. The new post-acute care transition program will assign a caregiver to participants’ homes and provide them other necessary resources, such as reconciling medications with their primary care provider, ensuring that the home is age-friendly, offering home visits and helping arranging food and transportation services. For additional details, click here.
FasterCures report develops tool for more equitable clinical trials
Important safeguards have been implemented to protect research participants such as the National Research Act and the Belmont Report, but there remains a need for equitable participation and benefit for diverse populations in clinical research. A new FasterCures report, Mapping the Journey: Building a Mutual Understanding for Health Equity in Clinical Research, provides a tool for stakeholders involved in clinical research to establish a common language and basis for exchange and understand the differences among different types of trial sites. The report also details practical recommendations for achieving health equity at different types of trial sites and a visual illustration of how a patient might experience a typical clinical trial. FasterCures’ aim with this tool and its ongoing work to achieve health equity is to promote a more accessible, equitable research enterprise and drive meaningful multi-stakeholder engagement.
Additional Reads
- First ‘gene silencing’ drug for Alzheimer’s disease shows promise (read here)
- Demographic diversity of genetic databases used in Alzheimer’s disease research (read here)
- In Medicare Drug Price Negotiations, Avoid Metrics Steeped In Stigma (read here)
- Common Infections Linked to Poorer Cognitive Performance in Middle-Aged and Older Adults (read here)
- Depression and anxiety in people with cognitive impairment and dementia during the COVID-19 pandemic: Analysis of the English Longitudinal Study of Ageing (read here)
- Dementia-Related Medication Disparities Persist for Racial, Ethnic Minority Patients (read here)
- How Some Common Drugs Can Increase the Risk of Dementia (read here)
- The associations of socioeconomic status with incident dementia and Alzheimer’s disease are modified by leucocyte telomere length: a population-based cohort study (read here)
- How Donanemab Compares With Aducanumab in Amyloid Clearance (read here)
- Sleeping pill reduces levels of Alzheimer’s proteins (read here)
- Online tool found to be effective at assessing dementia risk (read here)
- Genetic testing for Alzheimer’s is on the rise. But what happens when the results are dire? (read here)
- The Home Care Workforce Has Not Kept Pace With Growth In Home And Community-Based Services (read here)
- The Office of New Drugs’ Efforts to Expand Regulatory Science Research (read here)
- New project to measure Alzheimer’s and Parkinson’s via the ear (read here)
- Astrocyte Dysfunction Causes Cognitive Decline (read here)
- Blood Tests May Help Physicians in Low-Resource Environments Diagnose Alzheimer Disease (read here)
- Blood-based biomarkers for Alzheimer’s disease could greatly simplify diagnosis and reduce costs (read here)
- What Happens After Amyloid Plaque Removal? Who Benefits Most? (read here)
- What Does Plaque Clearance Mean for the Long Haul? (read here)
- A new peptide may hold potential as an Alzheimer’s treatment (read here)
- A PREP inhibitor may help stop the progression of frontotemporal dementia (read here)
- AI can spot early signs of Alzheimer’s in speech patterns, study shows (read here)
- Screening for Delirium: What Clinicians Should Know (read here)
- People Living With Early Alzheimer’s Need President Biden’s Help (read here)
- Activation of hypothalamic-enhanced adult-born neurons restores cognitive and affective function in Alzheimer’s disease (read here)
- Half of carers for people with dementia struggling to make ends meet, study finds (read here)
- Scientists Enhance New Neurons to Restore Memory, Elevate Mood in Alzheimer’s Disease Research Model (read here)
- Air pollution may increase risk for dementia (read here)
- Phototherapy improves cognitive function in dementia: A systematic review and meta-analysis (read here)
- Conquering Alzheimer’s: a look at the therapies of the future (read here)
- Understanding factors influencing residential respite service use by carers of people living with dementia using Andersen’s behavioural model of health services use: A qualitative study (read here)
- Early menopause ‘may make women more likely to develop dementia’ (read here)
- How Can We Support Religious and Spiritual Practices of Older Adults With Mild Cognitive Impairment and #Dementia? (read here)
March, 2023 News
Breaking News: ADRD Therapeutics Work Group publishes Appropriate Use Recommendations for LEQEMBI™
On March 27, the Alzheimer’s Disease and Related Disorders Therapeutics Work Group (ADRD TWG) published its Appropriate Use Recommendations (AUR) for LEQEMBI™ (lecanemab-irmb). The abstract states:
Lecanemab (Leqembi®) is approved in the United States for the treatment of Alzheimer’s disease (AD) to be initiated in early AD (mild cognitive impairment [MCI] due to AD or mild AD dementia) with confirmed brain amyloid pathology. Appropriate Use Recommendations (AURs) are intended to help guide the introduction of new therapies into real-world clinical practice. Community dwelling patients with AD differ from those participating in clinical trials. Administration of lecanemab at clinical trial sites by individuals experienced with monoclonal antibody therapy also differs from the community clinic-based administration of lecanemab. These AURs use clinical trial data as well as research and care information regarding AD to help clinicians administer lecanemab with optimal safety and opportunity for effectiveness. Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Monitoring guidelines for these events are detailed in this AUR. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal. Microhemorrhages and rare macrohemorrhages may occur in patients receiving lecanemab. Anticoagulation increases the risk of hemorrhage, and the AUR recommends that patients requiring anticoagulants not receive lecanemab until more data regarding this interaction are available. Patients who are apolipoprotein E ε4 (APOE4) gene carriers, especially APOE4 homozygotes, are at higher risk for ARIA, and the AUR recommends APOE genotyping to better inform risk discussions with patients who are lecanemab candidates. Clinician and institutional preparedness are mandatory for use of lecanemab, and protocols for management of serious events should be developed and implemented. Communication between clinicians and therapy candidates or those on therapy is a key element of good clinical practice for the use of lecanemab. Patients and their care partners must understand the potential benefits, the potential harms, and the monitoring requirements for treatment with this agent. Culture-specific communication and building of trust between clinicians and patients are the foundation for successful use of lecanemab.
Administration releases FY 2024 budget proposal
Most administrations’ annual budget proposals are considered effectively “dead on arrival” by Congress, since Congress exerts control through the House and Senate Appropriations Committees. Especially in periods of divided government, this maxim tends to hold true. So while the FY 2024 Budget Proposal and the departmental Budget in Brief documents are important markers of what the Administration hopes its allies in Congress will support, they are unlikely to prove meaningful predictors of the funding levels that will be signed into law at the end of the FY 2024 congressional appropriations process.
Nonetheless, it is disappointing and troubling that the documents released on March 9 and March 13 fall far short of meeting urgent needs of the dementia community. For example, the proposal would increase overall NIH funding by only $920 million (far below the average annual increases in recent years) and shockingly would provide a paltry $16 million increase to the National Institute of Neurological Disorders and Stroke (NINDS) and provide no increase at all to the National Institute on Aging (NIA) — the two NIH institutes that are central to federal research on Alzheimer’s, FTD, LBD, VCID, and mix forms of dementia. Dementia research essentially would be flat-funded and, in fact, eroded by the effects of medical research inflation. This flies in the face of NIH’s own congressionally mandated, rigorous assessment of need articulated in the FY 2024 Professional Judgment Budget for Alzheimer’s Disease and Related Dementias. And while there are some laudable proposed increases in social safety net programs such as those at the Administration for Community Living, it is concerning that the Administration has proposed flat-funding for the Alzheimer’s Disease Program, Prevention of Elder Abuse and Neglect, and the Traumatic Brain Injury Program. For additional details, see the National Council On Aging (NCOA) table summarizing the Administration’s proposed 2024 funding for aging services programs.
LEAD Coalition member and allied organizations should remain optimistic in working with Congress and the Administration to take this starting point and refine it in the coming months to produce actual funding levels that better meet the urgent needs of the dementia community. Together, this stakeholder community can and must accelerate equity-centered and person-centered progress in risk reduction, detection and diagnosis, support to protect and promote quality of life for people with dementia and their care partners, and the pharmacologic and non-pharmacologic science to prevent, slow, stop and eventually end all forms of dementia.
Senators press HHS Secretary on CMS non-coverage of new Alzheimer’s treatments
CDC report examines racial and ethnic differences in subjective cognitive decline
VHA will provide veterans with broad coverage for LEQEMBI™
In a welcome break from the policy adopted by CMS, the U.S. Veterans’ Health Administration (VHA) is providing coverage for LEQEMBI™ (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease (AD). VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI™ to veterans who fit the VHA’s criteria and the U.S. Food and Drug Administration’s (FDA) current label. As Time Magazine reported, “The VA added Leqembi, which received accelerated approval from the Food and Drug Administration in January, to its list of nonformulary drugs. Patients who want to take the drug would have to request it and receive prior approval and meet stringent inclusion criteria, according to the VA website.”
LEQEMBI™: FDA priority review granted, July 6 PDUFA date set
The U.S. Food and Drug Administration (FDA) has accepted Eisai‘s supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI™ to a traditional approval. The LEQEMBI™ application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application, but has not publicly announced the date of the meeting. The sBLA is based on the findings from Eisai’s recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI™ met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
LEQEMBI™ was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI™ reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI™‘s clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. For additional details, see the full Eisai statement.
Roche and Lilly collaborating for early diagnosis of Alzheimer’s disease
Roche recently announced (see Reuters coverage) a new collaboration with Eli Lilly to support development of Roche’s Elecsys Amyloid Plasma Panel (EAPP). The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease. In July, Roche announced that the U.S. Food and Drug Administration granted the EAPP Breakthrough Device Designation. The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau181 occur in early stages of Alzheimer’s, while the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline. A two-year clinical trial is expected to involve several hundred study participants with early signs of dementia, and trial data may be available for an FDA regulatory filing as soon as 2025.
In December 2022, Roche also received FDA 510(k) clearance for its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays, which identify Alzheimer’s pathology in its early symptomatic stage.
Alzheimer’s Association publishes annual Facts and Figures report and special report on clinical conversations
On March 15, the Alzheimer’s Association released its 2023 Alzheimer’s Disease Facts and Figures report, providing an in-depth look at the latest national statistics on Alzheimer’s incidence, prevalence, mortality, costs of care, and impact on caregivers. The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression, and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available. For additional background, see the Alzheimer’s Association press release.
Dementia risk reduction infographic culturally tailored for AIAN communities
The International Association for Indigenous Aging (IA²) has adapted The Lancet Risk Factors for Dementia infographic and created a version, “Help Reduce Your Risks of Dementia,” culturally tailored toward American Indian and Alaska Native (AIAN) communities. The process of creating this infographic included talking circles with tribal community members, Dementia Friends & Champions, the University of Nevada, Reno Dementia Engagement, Education and Research (DEER) Program, IA²’s Brain Health Leadership team, and internal IA² staff members. This infographic is intended to be used within the Dementia Friends for American Indian and Alaska Native Information Session workbook.
NIH names new director for Tribal Health Research Office
Earlier this month, Lawrence Tabak, DDS, PhD, in performing the duties of the NIH director, announced that Karina Walters, PhD, MSW, will serve as the next director of the NIH Tribal Health Research Office (THRO). An enrolled member of the Choctaw Nation of Oklahoma, “Dr. Walters’ wealth of experience and deep commitment to engaging tribal leadership in health research efforts makes her ideally suited for the position,” Tabak said. “Her commitment to community-based participatory research is evident in her demonstrated ability to sustain collaborations with diverse Native communities and conduct successful randomized clinical trials in tribal communities,” he added. Walters succeeds David Wilson, PhD, who is on detail to the White House Council on Native American Affairs, and she will begin her new role as the THRO Director on April 24. For more information about Dr. Walters, click here.
NAC releases guide for patient advocacy groups to better support diverse family caregivers
The National Alliance for Caregiving (NAC) has released a new publication, Supporting Diverse Family Caregivers: A Guide for Patient Advocacy Groups, developed through research with professional patient advocacy group representatives and diverse family caregivers. The report addresses the impact of culture and identity on the way that family caregivers provide care, and introduces ways in which patient advocacy groups can support their caregiving experience through culturally responsive resources and supports. The number of diverse family caregivers in the United States is growing yearly, and their aggregate number will soon surpass non-Hispanic white, non-LGBTQ+ caregivers. According to Caregiving in the U.S. 2020, of the 53 million family caregivers in the United States, 17% identify as Hispanic/Latino, 14% identify as African American, 8% identify as LGBTQ+, and 5% identify as Asian American or Pacific Islander. The Centers for Disease Control and Prevention identifies one in every four American Indian or Alaska Native adults as family caregivers.
Additional Reads
- Alzheimer’s: New Study Supports Amyloid Hypothesis But Suggests Alternative Treatment (read here)
- Machine learning models rank predictive risks for Alzheimer’s disease (read here)
- In the whitewashed world of Alzheimer’s research, one scientist is on a quest to understand the diversity of brains (read here)
- Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds (read here)
- Getting to the root of Alzheimer’s disease (read here)
- Researchers propose a novel biomarker for early diagnosis of Alzheimer’s disease (read here)
- Individualized brain fingerprints can help to uncover early signs of Alzheimer’s disease (read here)
- Your Speech May Reveal Early Signs of Alzheimer’s (read here)
- Comparative Effectiveness and Safety of Oral Anticoagulants by Dementia Status in Older Patients With Atrial Fibrillation (read here)
- Food Insecurity and Cognitive Trajectories in Community-Dwelling Medicare Beneficiaries 65 Years and Older (read here)
- Gene therapy approach to boost ‘cold shock protein’ in the brain without cooling protects mice against neurodegenerative disease (read here)
- Why Alzheimer’s and Dementia Cause Mood Swings, and What to Do About Them (read here)
- Helping Older Adults Manage Alzheimer’s and Other Dementias (watch here)
- Are Hospitals Ready for Alzheimer’s Treatment Approval? (read here)
- Researchers identify new genes that modulate the toxicity of the protein β-amyloid, responsible for causing Alzheimer’s disease (read here)
- New Insights into Atypical Alzheimer’s Disease: From Clinical Phenotype to Biomarkers (read here)
- Blood Pressure Control May Help Mitigate Dementia Risk From Hypertension (read here)
- Promise of exosomal proteins as biomarkers in Alzheimer’s disease (watch here)
- Readmission Rates and Episode Costs for Alzheimer Disease (read here)
- Webinar: Alzheimer’s Treatment and Access (watch here)
- Masking a Splicing Site Compensates for TDP-43 Dysfunction (read here)
- Dementia, incontinence and the loss of dignity in acute hospitals (read here)
- Risk of death for people with dementia increases after a hurricane exposure (read here)
- Diabetes and Toothlessness Together Worsen Cognitive Decline (read here)
- Solving the Alzheimer’s Disease Puzzle: One Piece at a Time (read here)
- Lifetime discrimination linked to 40% higher risk of dementia, study finds (read here)
- Education and Dementia Incidence by Ethnicity and Nativity in Older Asian American Individuals (read here)
- Could Calming Overactive Ryanodine Receptor Restore Autophagy? (read here)
- Alzheimer’s Gene MS4A4A Governs the State of Microglia (read here)
- New Research Finds Antibody Detects Alzheimer’s Signals at Earliest Stages (read here)
- Do you already have Alzheimer’s? That’s what scientists at KU are asking young people (read here)
- Early diagnosis of Alzheimer’s disease (read here)
- Trouble falling asleep at bedtime or in the middle of the night? It could impact your risk for developing dementia (read here)
- No Country for Alzheimer’s Patients (read here)
- Those Declining Dementia Rates? It’s Not the Plaques and Tangles (read here)
- Black People Less Likely to Receive Dementia-Related Medications (read here)
- The Alzheimer’s Crisis in Indian Country (read here)
- Detecting mild cognitive impairment and dementia in older adults using naturalistic driving data and interaction-based classification from influence score (read here)
- Prevalence, Timing, and Network Localization of Emergent Visual Creativity in Frontotemporal Dementia (read here)
- Researchers identify three intestinal bacteria found in dementia with Lewy bodies (read here)
- Degrading modified proteins could treat Alzheimer’s, other ‘undruggable’ diseases (read here)
- Alzheimer’s and falls can be predicted using radar (read here)
- New Insights: Eye Damage in Alzheimer’s Disease Patients (read here)
- Why evenings can be harder on people with dementia—and how to cope (read here)
- Alzheimer’s Study Links Cholesterol And Toxic Protein Clusters (read here)
- Osteopontin may play key role in Alzheimer’s disease (read here)
- Distressing dreams in childhood and risk of cognitive impairment or Parkinson’s disease in adulthood: a national birth cohort study (read here)
- Vitamin D supplementation and incident dementia: Effects of sex, APOE, and baseline cognitive status (read here)
- Lilly Provides Update on A4 Study of Solanezumab for Preclinical Alzheimer’s Disease (read here)
- NIA statement on study results suggesting solanezumab does not reduce cognitive decline in people at risk for developing Alzheimer’s (read here)
- How Does Hospice Care Work? (read here)
- Study identifies four distinct pain trajectories in nursing home residents (read here)
- New AARP Report Finds Family Caregivers Provide $600 Billion in Unpaid Care Across the U.S. (read here)
- Senior care is crushingly expensive. Boomers aren’t ready. (read here)
- New report finds artificial intelligence fuels ageism in aged care (read here)
- DNA Treatment Could Delay Paralysis That Strikes Nearly All Patients with ALS (read here)
February, 2023 News
Breaking News: Director of FDA Office of Neuroscience announces retirement
Billy Dunn, M.D. is retiring from the U.S. Food and Drug Administration (FDA), where he has led the Office of Neuroscience (ON) in the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND). According to reporting in BioPharma Dive, Teresa Buracchio, M.D., an FDA veteran and currently the acting deputy director of the Office of Neuroscience, will take Dunn’s place on an acting basis.” The Office of Neuroscience consists of five review divisions: The Division of Neurology I, the Division of Neurology II, the Division of Psychiatry, the Division of Anesthesiology, Addiction Medicine, Pain Medicine, and the Division of Pharm/Tox for Neuroscience (DPT-N). The Immediate office oversees the development, review, and regulation of applications as well as issues related to toxicology for drug and biologic products reviewed in these divisions.
Dr. Dunn has served at FDA for over 17 years. Prior to joining FDA, Dr. Dunn served as a clinician and clinical researcher at the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). Dr. Dunn has served with distinction as a thoughtful leader and innovator, a determined regulator, and a powerful voice for addressing the high unmet needs of often marginalized people facing debilitating and life-threatening health conditions. The LEAD Coalition is deeply grateful for Dr. Dunn’s vision, leadership, and abiding commitment to improving quality of life for all who experience neurological disorders.
Check back here for updates on this breaking news.
FDA expects to complete reviews of brexpiprazole for Alzheimer’s dementia agitation by May 10
The U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (reported in approximately 45 percent of patients with Alzheimer’s dementia) and has a large impact on quality of life for the people living with AAD, family members, and caregivers. Agitation covers a large group of behaviors, and it is an excessive manifestation of “normal” human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting. Brexpiprazole (Rexulti), an antipsychotic medication approved in 2015 by the FDA as adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood.
FDA has assigned the sNDA priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10. The FDA also anticipates holding a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application, but a meeting date has not been set. According to brexpiprazole’s sponsors, Otsuka Pharmaceuticals and Lundbeck, the sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 (NCT01862640) demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213 (NCT03548584), treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
CMS rejects request to reconsider its denial of coverage for FDA-approved Alzheimer’s disease treatments
On February 22, the Centers for Medicare & Medicaid Services (CMS) rejected (see: full CMS statement) a formal request to reconsider its national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N). As noted in the subsequent Alzheimer’s Association statement, CMS covers all FDA-approved drugs except for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. The American Academy of Neurology (AAN) also had formally requested (see AAN letter) that CMS initiate an expedited NCD reconsideration focused on lecanemab (LEQEMBI™) and based on the phase III data from the CLARITY AD trial published in the New England Journal of Medicine, which showed clinical meaningful benefits including slowing of cognitive dysfunction and a decrease in the decline of activities of daily living. AAN wrote, in part, “Throughout the National Coverage Analysis (NCA) and NCD processes, the AAN repeatedly raised concerns regarding the potential unintended consequences of applying this NCD to the entire class of mAbs for the treatment of Alzheimer’s disease. The AAN is concerned that absent a reconsideration of the NCD, patients who could benefit from lecanemab will be denied access, due to restrictions found in the NCD, leading to irreversible disease progression that could have been slowed with treatment.”
Video and materials now available from recent NAPA Advisory Council meeting
The Advisory Council on Alzheimer’s Research, Care, and Services held a virtual meeting on January 30 and 31. The Advisory Council received presentations on issues related to clinical practice and plans for advanced care planning, and reviewed the impact of new drug approvals and focus on risk reduction and social determinants of health. The National Institute of Neurological Disorders and Stroke (NINDS) presented on gaps and opportunities from the 2022 ADRD Summit, and other federal agencies will provided updates. Full meeting materials now are available, including video of all presentations, public comments, and Advisory Council discussions.
Report on CMS expanded use of Coverage with Evidence Development
The Alliance for Aging Research has published a new report, Façade of Evidence: How Medicare’s Coverage with Evidence Development Paradigm Rations Care and Exacerbates Inequity, which provides an overview of Coverage with Evidence Development (CED), CED’s deficiencies and harmful consequences, and how recent application of CED by the Centers for Medicare and Medicaid Services (CMS) set a dangerous precedent for future Medicare coverage. (An executive summary is available here.) According to the report, CMS increasingly is employing CED to restrict access to drugs, biologics, diagnostics, and medical devices approved by the FDA.
White paper examines urgency for Alzheimer’s policy solutions including innovation, treatment access, and caregiving
A new Alliance for Patient Access white paper, “Overburdened by Alzheimer’s: The Need for Care Innovation and Access,” highlights the disease’s burden and explores policies that could improve patient care. While no cure exists, treatment can slow Alzheimer’s disease progression and relieve patients’ symptoms. The paper identifies several policy solutions to help patients access innovative treatments and effective care:
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- Better coverage. Health plans can improve coverage for screenings, like PET scans and blood biomarker tests, to improve patients’ opportunities to benefit from a timely and accurate diagnosis.
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- Ongoing research. Funds can be invested for more research into disease-modifying therapies, and insurers can ensure such treatments are accessible to patients as they become available.
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- Caregiver support. Policymakers can collaborate to better support and resource caregivers.
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- Long-term care solutions. Policy solutions can make both at-home and residential care more accessible and affordable.
Hope for an Alzheimer’s cure remains. But in the meantime, the paper concludes, the nation can’t afford simply to wait.
Fact sheet explains how to protect dually eligible older adults when Medicaid public health emergency flexibilities end
Starting this Spring, millions of older adults who are dually eligible for Medicare and Medicaid will face redeterminations of their Medicaid eligibility, a process that had been suspended during the COVID-19 Public Health Emergency (PHE). Emergency flexibilities in delivery of Medicaid services also will begin to expire. This process will present significant challenges for states and for dually eligible for individuals who, compared to Medicare-only enrollees, have higher rates of disability and require more assistance with activities of daily living, experience higher rates of poverty leading to housing instability, and often need communication accommodations due to disability or limited English proficiency. A new Justice in Aging fact sheet, “Unwinding Medicaid Continuous Coverage Protections: Implications and Advocacy for Individuals Dually Eligible for Medicare and Medicaid,” provides information about the “unwinding” process and identifies steps that advocates can take with their states and partners to address the specific challenges facing dual eligible individuals during this transition.
In a related development, a new Kaiser Family Foundation issue brief, “Understanding the Role of Medicaid Managed Care Plans in Unwinding Pandemic-Era Continuous Enrollment: Perspectives from Safety-Net Plans,” shares how states can partner with Medicaid managed care organizations (MCOs) to prepare beneficiaries for the unwinding process. MCOs deliver care to more than two thirds of Medicaid beneficiaries.
Study finds correlation between care quality and online ratings for assisted living communities
A study recently published in the Journal of the American Geriatrics Society found that residents who live in assisted living communities with high online ratings spent more time at home—and less time in hospitals, nursing homes and other institutional settings—compared with those who live in assisted living communities that had no or low ratings. The study, which included 59,831 Medicare beneficiaries in 12,143 assisted living communities, was based on Google searches conducted on assisted living communities between 2013 and 2017 and linked to 2018–2019 Medicare data. Study authors observed that the absence of state or federal mandatory reporting requirements for assisted living communities, may leave customers to make decisions based on price and amenities rather than on vetted and comparative data regarding quality.
NTG issues advisory on over-medication of persons with intellectual disability
The National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and the Health Matters Program at the University of Illinois Chicago have issued a new advisory, “Over-Medication and Older Adults with Intellectual Disability: Risks for Brain Health,” which cautions users and families about several issues that arise from over-prescription and over-medication. The advisory offers suggestions for actions that primary care practitioners may undertake to review medications and their impact, as well as what families may do to become better informed and request medication reviews. The National Institute on Aging (NIA) and other organizations have noted that too often there is an accumulation of medications taken by older adults, and some of these medications may be no longer necessary or result in adverse effects. Studies show that many adults with intellectual disability are on numerous medications over their lifetime. Among older adults, some of these medications are still being taken even if unnecessary, others taken may cause behavioral problems or adverse health effects. Some taken for long periods may lead to cognitive problems and possibly dementia. The advisory notes a critical distinction between the use of ‘appropriate polypharmacy,’ which involves the prescribing of multiple medications that are clinically necessary and appropriate for the patient, and ‘inappropriate polypharmacy,’ which involves being prescribed many medications which if taken at the same time can be harmful if taken for too long, in an questionable dosage, and without considering drug interactions.
Additional Reads
- Predictors of cognitive functioning trajectories among older Americans: A new investigation covering 20 years of age- and non-age-related cognitive change (read here)
- Apathy as a Predictor of Conversion from Mild Cognitive Impairment to Alzheimer’s Disease: A Texas Alzheimer’s Research and Care Consortium (TARCC) Cohort-Based Analysis (read here)
- Machine Learning Selection of Most Predictive Brain Proteins Suggests Role of Sugar Metabolism in Alzheimer’s Disease (read here)
- Integrative in situ mapping of single-cell transcriptional states and tissue histopathology in a mouse model of Alzheimer’s disease (read here)
- When Perivascular Macrophages Spew SPP1, Microglia Eat Synapses (read here)
- Effect of long-term caloric restriction on DNA methylation measures of biological aging in healthy adults from the CALERIE trial (read here)
- Short-Term and Long-Term Sensitization Differentially Alters the Composition of an Anterograde Transport Complex in Aplysia (read here)
- Obesity-Associated Neurodegeneration Pattern Mimics Alzheimer’s Disease in an Observational Cohort Study (read here)
- Proton Pump Inhibitor Use and Risk of Dementia in Older Adults: A Systematic Review (read here)
- Costs During the Last Five Years of Life for Patients with Clinical and Pathological Confirmed Diagnosis of Lewy Body Dementia and Alzheimer’s Disease (read here)
- Dementia care programs help, if caregivers can find them (read here)
- No Easy Answers on Clinical Meaningfulness of Alzheimer’s Treatments (read here)
- Payment For Comprehensive Dementia Care: Five Key Recommendations (read here)
- Three New Prescription Drug Innovation Models Latest Action on Drug Pricing (read here)
- Risk of Discharge to Lower-Quality Nursing Homes Among Hospitalized Older Adults With Alzheimer Disease and Related Dementias (read here)
- Rethinking how we train caregivers for people with dementia (read here)
- More Pain, More Burdens: Researchers Find Link between Chronic Pain and Dementia (read here)
- Could Alzheimer’s be caused by an infection? (read here)
- Food insecurity may increase cognitive decline in older adults (read here)
- Research suggests link between low-quality education, dementia (read here)
- New research aims to understand why women more likely to develop Alzheimer’s disease (read here)
- Multi-country dementia study shows women’s greater risk may be linked to disadvantage (read here)
- Scientists find genetic Alzheimer’s risk factor tied to African ancestry (read here)
- Trans people more likely to have long-term conditions like dementia and autism, major study finds (read here)
- Senators call on Medicare to offer broad coverage of Alzheimer’s treatments as public pressure grows (read here)
- Study Suggests Fructose Could Drive Alzheimer’s Disease (read here)
- Updated: FDA adds warning of ‘larger areas of bleeding’ in brain to Biogen’s Aduhelm label (read here)
- Watch Your Step! Balance Ability Predicts Cognitive Impairment (read here)
- The ‘Tipping Point’ Toward Alzheimer’s (read here)
- Rethinking The Future Of Dementia Care (read here)
- Understanding the Link Between Personal Finances and Early Alzheimer’s (read here)
- Spending time in nature may protect against the risk of dementia (read here)
- California Dangles Bonuses for Nursing Homes That Add Staff (read here)
- New brain atlases and digital tools will make brain research more efficient (read here)
TAKE ACTION | NEWS | LEGISLATION
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January, 2024 News
Congress extends appropriations CR
Congress has passed, and the President has signed, a new appropriations continuing resolution (CR) covering Agriculture-FDA, Energy-Water, Military Construction-VA, and Transportation-HUD until March 1, and the remaining eight appropriations bills (including Labor-HHS and Commerce, Justice, Science) until March 8. While congressional leaders have agreed on a $1.66 trillion spending cap for Fiscal Year 2024, they continue negotiating how the funds will be distributed among federal agencies and programs. Earlier this month, the LEAD Coalition joined with nearly 1,100 organizations on a Coalition for Health Funding letter urging Congress to reject any full-year CR that would result in cuts to non-defense discretionary (NDD) programs and instead adopt the bipartisan Senate funding framework for the Fiscal Year 2024 spending agreement.
For additional details and analysis, read articles from The Hill, Roll Call, and the Washington Post.
FDA and CMS issue joint statement on oversight of laboratory developed tests
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement reiterating mutual support of the FDA’s oversight of laboratory developed tests (LDTs), including the analytical and clinical validity of these tests. LDTs help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure these tests work and that patients along with health care providers are able to have warranted confidence that laboratory tests work. Therefore, last October, the FDA issued a notice of proposed rulemaking (Docket No. FDA-2023-N-2177) to help ensure the safety and effectiveness of LDTs by phasing out the FDA’s current approach to LDTs. If finalized, LDTs generally would fall under the same enforcement approach as other tests. CMS supports the FDA’s proposal.
CMS details American Rescue Plan state spending plans for HCBS
The Centers for Medicare & Medicaid Services (CMS) has released state spending plan summaries for section 9817 of the American Rescue Plan Act of 2021 (ARP). The spending plan summaries illustrate how states expect to spend $36.8 billion on activities to enhance, expand, or strengthen home and community-based services (HCBS) under Medicaid. Activities focus on workforce recruitment, retention, and training, quality improvement, reducing or eliminating waiting lists, expansions of the use of technology, opportunities to support caregivers, and ways to address social determinants of health and promote equity.
Three new members join USPSTF
The Agency for Healthcare Research and Quality (AHRQ) has appointed three new members to the U.S. Preventive Services Task Force (USPSTF) who will serve four-year terms, beginning this month. Dr. Sei Lee is a professor of medicine in the Division of Geriatrics at the University of California, San Francisco, and the Senior Scholar for the San Francisco Veterans Affairs Quality Scholars fellowship. Dr. Lee also chairs the American Geriatrics Society Quality and Performance Measurement Committee. He is a geriatrician and palliative care physician and has cared for patients in the clinic, hospital, and nursing home settings. Dr. Tonette Krousel-Wood is a professor and the Jack Aron endowed chair in primary care medicine in the Tulane School of Medicine Department of Medicine. She is the founding director of the Tulane Center for Health Outcomes, Implementation, and Community Engaged Science (CHOICES). She serves in several leadership roles at Tulane, including as the associate provost for the health sciences, senior associate dean of faculty in the School of Medicine, and associate dean for public health and medical education. Dr. Sarah Wiehe is the Jean and Jerry Bepko professor of pediatrics and associate dean of community and translational research at Indiana University School of Medicine. She is a research scientist at the Regenstrief Institute and adjunct professor of epidemiology at Fairbanks School of Public Health at Indiana University. Dr. Wiehe co-directs the Indiana Clinical and Translational Sciences Institute and leads its community engagement program. Full biographies for the new members and all USPSTF members are available here. AHRQ is accepting nominations until the March 15 deadline for members to begin service in 2025.
LEAD Coalition welcomes new member organization
The LEAD Coalition recently welcomed TauRx as its newest member organization. TauRx was founded in 2002 in Singapore, with primary research facilities and operation based in Aberdeen, UK. The company has dedicated the past two decades to developing treatments and diagnostics for Alzheimer’s and other neurodegenerative diseases due to tau protein aggregation pathology. TauRx will contribute to addressing this unmet need with data from the completed Phase 3 LUCIDITY trial and pursuit of regulatory approvals in line with its overall plans to make hydromethylthionine mesylate (HMTM) available to patients and pursue clinical development in other related neurodegenerative diseases.
ADvancing States publishes report on adult protective services
ADvancing States has published findings from the 2022 national survey of Adult Protective Services (APS) Programs in the report Adult Protective Services in 2022: Responding to Evolving Needs in a Changing Environment. ADvancing States conducted this survey to assess the current state of APS programs and identify trends related to topics such as caseload, staff retention, and client assessment. Additionally, there was a special focus placed on clients experiencing self-neglect. This report describes programmatic elements of APS, focuses on the people that the programs serve, identifies needed services, and explores opportunities to expand APS’ relationship with Medicaid.
NCAL issues review of state assisted living regulations
The National Center for Assisted Living (NCAL) recently issued its annual Assisted Living State Regulatory Review, which summarizes key selected state requirements for assisted living licensure or certification. The review provides information for every state and the District of Columbia on topics such as which state agency licenses assisted living, recent legislative and regulatory updates affecting assisted living, scope of care, limitations of services, staffing, and training. The report also includes requirements for communities that offer housing and person-centered supportive and/or health care services to older adults and people with disabilities, but may use a different term than assisted living.
High-quality nursing home dementia care is not only a matter of adding staff
Additional staffing alone will not be sufficient to bridge the quality-of-care and health outcome disparities among nursing home facilities with varying percentages of residents with dementia, according to a first-of-its-kind study led by the University of California, Irvine. Specialized training, an easy-to-navigate environment and staff stability are also critical to meeting the unique challenges presented by this population. The findings, recently published online in the journal Health Services Research, indicate that increased staffing generally improves outcomes for all patients but that at any given level of staffing, discrepancies between high- and low-dementia facilities remain. The impact on care differed by percentage of residents with dementia and various outcomes, ranging from daily activities such as independently bathing, dressing and eating to the number of emergency room visits and incidents of pressure sores. Researchers conducted regression analyses on a national sample of nursing homes between 2017 and 2019, drawing on a variety of datasets, including Medicare claims and the Centers for Medicare and Medicaid Services’ Payroll Based Journal. Independent variables included staff hours per resident-day and dementia population percentage, controlling for other resident and facility characteristics. Separate linear models were utilized to predict six long-term facility-level outcomes.
For Dementia Prevention, Sleep Quality in Midlife Matters More
A new study reveals that quality of sleep, not quantity, may play a part in the development of dementia decades before symptoms start. Unlike previous research that has primarily focused on sleep disturbance and cognitive impairment in late life, the 526 participants at the start of this study had an average age of 40. The researchers used a wrist activity monitor to record bedtime “sleep fragmentation,” which took into account the amount of time participants were immobile and the amount of time they were moving. After tracking the participants’ sleep habits and evaluating their cognitive performance years later, the researchers found no association between cognition and sleep duration, in analyzing both self-reports and data from the wrist activity monitors. In contrast, those with higher levels of fragmented sleep were found to be up to three times as likely to score below average in cognitive testing as those with lower levels of fragmented sleep, when adjusted for factors like education, depression, body mass index, diabetes and hypertension. The participants were part of CARDIA (Coronary Artery Risk Development In young Adults), a National Institutes of Health study. Over half were female; 56% were white and the remainder were Black. Their sleep habits were assessed over a three day-period on two occasions, approximately one year apart, and cognitive testing took place about 11 years later.
Additional Reads
- Association Between Sleep Quantity and Quality in Early Adulthood With Cognitive Function in Midlife (read here)
- A type of dementia that hits the brain of men and women differently (read here)
- Enhancing foveal avascular zone analysis for Alzheimer’s diagnosis with AI segmentation and machine learning using multiple radiomic features (read here)
- Thinning of brain region may signal dementia risk 5-10 years before symptoms (read here)
- Could Bizarre Visual Symptoms Be a Telltale Sign of Alzheimer’s? (read here)
- ‘It was really scary’: In the battle against dementia, support for caregivers is crucial (read here)
- Research into the nature of memory reveals how cells that store information are stabilized over time (read here)
- New cause of neuron death in Alzheimer’s discovered (read here)
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Definition of a Threshold for the Plasma Aβ42/Aβ40 Ratio Measured by Single-Molecule Array to Predict the Amyloid Status of Individuals without Dementia (read here)
- Alzheimer proteopathic tau seeds are biochemically a forme fruste of mature paired helical filaments (read here)
- New links between late-onset Alzheimer’s disease and the immune system (read here)
- Research evaluates how retina could yield early Alzheimer’s disease diagnosis (read here)
- Police Pilot New Tactics for People With Dementia as Advocates Urge Compassion (read here)
- Dementia risk factors differ among ethnicities (read here)
- Synthetic memories: Piecing together the past with AI (read here)
- Research reveals new hope for obesity-induced heart disease (read here)
- The Accelerated Approval Regulatory Pathway With the USA FDA Commissioner Robert Califf (read here)
- Senate to examine walkaway deaths in assisted-living facilities (read here)
- Monitoring synaptic pathology in Alzheimer’s disease through fluid and PET imaging biomarkers: a comprehensive review and future perspectives (read here)
- Exploring the Role of Brexpiprazole in Alzheimer Dementia Agitation (read here)
- Statins and risks of dementia among patients with heart failure: a population-based retrospective cohort study in Hong Kong (read here)
- TREM2 variants that cause early dementia and increase Alzheimer’s disease risk affect gene splicing (read here)
- A Brief Update on Alzheimer’s Diagnosis and Treatment (read here)
- Association of long-term exposure to various ambient air pollutants, lifestyle, and genetic predisposition with incident cognitive impairment and dementia (read here)
- Combining two techniques could spot Alzheimer’s disease sooner (read here)
- Neurosurgeon works to slow Alzheimer’s progression, treat addiction with cutting-edge technology (read here)
- Evidence grows of air pollution link with dementia and stroke risk (read here)
- Dementia-friendly tourism is on the rise—here’s why it’s so important (read here)
- Flagging Dementia Patients for Better Hospital Care (read here)
- Different biological variants discovered in Alzheimer’s disease (read here)
- Blood tests can help diagnose Alzheimer’s — if they’re accurate enough. Not all are (read here)
- Generative Artificial Intelligence Models Effectively Highlight Social Determinants of Health in Doctors’ Notes (read here)
- Naomi Feil, Who Transformed Dementia Care, Dies at 91 (read here)
- Buck Scientists Identify How Dietary Restriction Slows Brain Aging & Increases Lifespan (read here)
- Is the Montreal cognitive assessment culturally valid in a diverse geriatric primary care setting? Lessons from the Bronx (read here)
- Study: Amyloid-β protein affects cognitive decline after small-sized cerebral infarction (read here)
- Cerebrospinal fluid proteomics in patients with Alzheimer’s disease reveals five molecular subtypes with distinct genetic risk profiles (read here)
- A common marker of neurological diseases may play role in healthy brains (read here)
- “Exhausted” immune cells may drive Alzheimer’s (read here)
- Brain areas lipidomics in female transgenic mouse model of Alzheimer’s disease(read here)
- Molecular Biomarkers to Diagnose Vascular Cognitive Impairment and Dementia (read here)
- Is It a Quirky Behavior or Alzheimer’s? (read here)
- How Do You Explain Dementia to a Child? (read here)
- Neural stem cell homeostasis is affected in cortical organoids carrying a mutation in Angiogenin (read here)
- Upping the Ante for Predicting the Success of Alzheimer Disease Treatments (read here)
- Similar Risk Factors Found for Young- and Late-Onset Dementia (read here)
- Alzheimer’s Disease: The Past, Present, and Future of a Globally Progressive Disease (read here)
- Exploring the ANGPT-TIE Signaling Pathway in Alzheimer’s Disease: Potential Therapeutic Opportunities (read here)
- Hearing loss increases the risk of dementia (read here)
- Hearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults (read here)
- My Parents’ Dementia Felt Like the End of Joy. Then Came the Robots. (read here)
- Cryptic splicing of stathmin‑2 and UNC13A mRNAs is a pathological hallmark of TDP‑43‑associated Alzheimer’s disease (read here)
- Ultrasound Blood–Brain Barrier Opening and Aducanumab in Alzheimer’s Disease (read here)
- Football linked to damage of white matter in brain, a marker of dementia (read here)
- NIA at 50: Celebrating aging research advances and career opportunities (read here)
- Clinical staging of behavioral and psychological symptoms of dementia (read here)
- Association Between Sleep Quantity and Quality in Early Adulthood With Cognitive Function in Midlife (read here)
- Balancing Autonomy And Public Safety: A Call For Medical And Regulatory Oversight Of Drivers With Cognitive Decline (read here)
- Atypical instantaneous spatio-temporal patterns of neural dynamics in Alzheimer’s disease (read here)
- Native PLGA nanoparticles attenuate Aβ-seed induced tau aggregation under in vitro conditions: potential implication in Alzheimer’s disease pathology (read here)
- Alzheimer Agent Lomecel-B Meets Primary End Point in Phase 2a CLEAR MIND Study (read here)
- Deep Brain Stimulation May Benefit Patients With Alzheimer Disease, But More Research Is Needed (read here)
- Novel Alzheimer’s Trials Evaluate Senolytics, Semaglutide, CRISPR, and More (read here)
- Androgen deprivation therapy for prostate cancer and neurocognitive disorders: a systematic review and meta-analysis (read here)
- An ensemble learning model for continuous cognition assessment based on resting-state EEG (read here)
- Heterogeneous factors influence social cognition across diverse settings in brain health and age-related diseases (read here)
- Association between surgery and rate of incident dementia in older adults: A population‐based retrospective cohort study (read here)
- scMD facilitates cell type deconvolution using single-cell DNA methylation references (read here)
- Tripartite motif-containing protein 11 (TRIM11): a novel weapon against Alzheimer’s disease (read here)
- Alzheimer’s: ‘Cultivating hope is an act of resilience’ (read here)
December, 2023 News
HHS releases National Alzheimer’s Plan 2023 Update
U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra has released HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition. The plan is developed with input from agencies across HHS and other federal departments as well as recommendations from the Advisory Council, whose members include healthcare providers, researchers, caregivers, individuals living with dementia, state representatives, and advocates. For additional information, see the HHS statement.
FDA publishes three new guidances on real world evidence and data
The U.S. Food and Drug Administration (FDA) has published a series of guidances to help advance real world evidence (RWE) and real world data (RWD) and recently published three additional guidances in this series:
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, which updates and clarifies how the FDA evaluates RWD to determine if it is sufficient to be used in regulatory decision making for medical devices and provides expanded recommendations for sponsors collecting RWD. (Federal Register Docket No. FDA-2023-D-4395)
- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, which provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. (Federal Register Docket No. FDA-2021-D-1146)
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data, which addresses considerations for the use of data standards currently supported by the FDA in applicable drug submissions containing study data derived from RWD sources. (Federal Register Docket No. FDA-2021-D-0548)
Supporting a robust data infrastructure, developing new methods and analytical tools, and integrating RWE with traditional clinical trial evidence will require collaboration across the clinical care, research and technology sectors, in addition to direct involvement of patients. To help in this context, the FDA is supporting research or demonstration projects that seek to improve the quality of RWD and RWE. Strengthening systems for generating and gathering new and better data and analyzing those data is vital to provide reliable evidence to inform and improve the many decisions made by consumers, patients, families, clinicians and regulators. The FDA already is capable of reviewing submissions that include or rely entirely on RWD. Enabling advanced data analytics, including RWD, also is incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. Ongoing agency initiatives will continue to promote awareness of, and consistency in, reviewing submissions with RWD.
FDA issues final guidance for rare disease drugs and biologics
The U.S. Food and Drug Administration (FDA) has issued final guidance to assist sponsors of drugs and biological products for treatment of rare diseases in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development. This guidance, entitled “Rare Diseases: Considerations for the Development of Drugs and Biological Products,” finalizes the draft guidance entitled “Rare Diseases: Common Issues in Drug Development” issued on February 1, 2019. This final guidance addresses important aspects of drug and biological product development to support the proposed clinical investigation(s), including nonclinical pharmacology/toxicology; trial design and endpoint considerations to ensure quality and interpretability of data; standard of evidence to establish safety and effectiveness; and drug manufacturing considerations during drug development. Changes made from the draft to the final guidance took into consideration comments received. Major changes include the removal of the natural history section (because this is addressed in a separate guidance), additional considerations regarding nonclinical studies, information on the use of external controls and early randomization, a section discussing safety considerations, information on changes to drug substance or manufacturing process, and sections discussing participation of patients/patient groups in drug development programs and pediatric considerations in rare disease drug development. For additional details, see the Federal Register notice (Docket No. FDA-2015-D-2818).
CMS issues information bulletin on HCBS worker registries
The Centers for Medicare & Medicaid Services (CMS) has released an information bulletin outlining how states can use worker registries for Medicaid-funded home and community-based services (HCBS) to ensure beneficiaries have awareness of, and access to, qualified workers to deliver these critical services. The guidance focuses on building and maintaining worker registries — worker management platforms that make qualified health workers easier to find — so more individuals receiving Medicaid-covered services can get care in a setting of their choice. The guidance also notes that significant federal funding is available through the American Rescue Plan (ARP) to help states build these registries. CMS also released data on how enhanced funding for HCBS, provided through the ARP, has been invested to strengthen access to HCBS nationwide. The funding includes investments to help retain, expand, and train the direct care workforce, as well as investments to support family caregivers and reduce or eliminate waitlists for community-based care.
Report recommends action to address the direct care workforce shortage
The Bipartisan Policy Center has unveiled a report, Addressing the Direct Care Workforce Shortage: A Bipartisan Call to Action, highlighting the critical shortage of direct care workers in the United States and underscoring the urgent need for federal policy reforms to address this escalating crisis. Addressing these challenges is critical to not only ensuring a robust direct care workforce, but also to promoting gender and racial equity, as the current workforce is comprised disproportionately of women (86%), people of color (60%), and immigrants (25%). This moment also presents an important opportunity for federal policymakers to improve care access and quality while making progress in fully integrating individuals with disabilities into the community, as required by the Supreme Court in Olmstead v. L.C., 527 U.S. 581 (1999).
This report includes bipartisan legislative and administrative federal policy solutions to (1) promote retention of direct care workers through reforms that encourage more supportive work environments, including assisting unpaid caregivers who incur significant financial burdens while relieving pressure on the paid workforce; (2) increase the number of workers through domestic and immigration policy reforms; and (3) improve standardized data collection and publicly available data on the direct care workforce to measure the effects of these efforts and inform evidence-based policymaking.
Serotonin loss may contribute to cognitive decline in early stages of Alzheimer’s disease
Comparing PET scans of more than 90 adults with and without mild cognitive impairment (MCI), researchers found that relatively lower levels of serotonin in parts of the brain of those with MCI may play a role in memory problems including Alzheimer’s disease. The findings, published in the Journal of Alzheimer’s Disease, support growing evidence that measurable changes in the brain happen in people with mild memory problems long before an Alzheimer’s diagnosis and may offer novel targets for treatments to slow or stop disease progression. The investigators cautioned that their study showed a correlation between lower serotonin transporter levels and memory problems in MCI and was not designed to show causation or the role of serotonin in the progression from MCI to AD. To answer these questions, further research is needed to study over time healthy controls and individuals with MCI to demonstrate the role of serotonin in disease progression.
Additional Reads
- Alzheimer’s Microglial Risk Gene INPP5D Revs Up Inflammasome (read here)
- The healthcare system continues to discriminate against Alzheimer’s patients (read here)
- Dementia has allowed my mum to live in the present. If she can forget, then maybe so can I (read here)
- Daily learning test can detect Alzheimer’s disease-related changes in memory among cognitively normal older adults (read here)
- Negative Wealth Shock and Cognitive Decline and Dementia in US Adults (read here)
- Alcohol misuse and loneliness ‘increase risk of early-onset dementia’ (read here)
- Plaques Kick Neocortical Neurons into Overdrive, Entangling Tau (read here)
- Risk of young-onset dementia could be reduced through targeting health and lifestyle factors (read here)
- Bolstering our sense of smell may reduce the risk of dementia (read here)
- How these six simple acts could reduce your risk of Alzheimer’s (read here)
- New Atlas Charts Mouse Brain in Exquisite Detail (read here)
- Predicting Alzheimer’s Dementia in Oldest of the Old (read here)
- Midlife blood test may predict cognitive decline, Alzheimer’s in later life (read here)
- ‘Slide-tags’ Method Sharpens Spatial Transcriptomics (read here)
- Home-Delivered Meals and Nursing Home Placement Among People With Dementia (read here)
- Digital training programme improves quality of life for care residents with dementia – even during the Covid-19 pandemic (read here)
- Finding that statins could slow dementia stimulates further research (read here)
- New treatment reverses Alzheimer’s disease signs, improves memory function in preclinical study (read here)
- “They Will Come at Me”: New Study Investigates Fear of Retaliation in America’s Nursing Homes (read here)
- Common drug for cardiac failure jams a debated blood test for Alzheimer’s disease (read here)
- Audiovisual gamma stimulation for the treatment of neurodegeneration (read here)
- Taking out the cellular trash (read here)
- What You Can Do Now to Prevent Memory Loss (read here)
- Alzheimer’s Discovery Reveals Dire Effect of Toxic Tau Protein (read here)
- How one designer is helping dementia patients unlock forgotten memories (read here)
- APOE Christchurch Variant Tames Tangles and Gliosis in Mice (read here)
- Serum proinsulin levels as peripheral blood biomarkers in patients with cognitive impairment (read here)
- Dozens of assisted-living residents died after wandering away unnoticed (read here)
- The iceberg of dementia risk: empirical and conceptual arguments in favor of structural interventions for brain health (read here)
- Cerebral organoids with chromosome 21 trisomy secrete Alzheimer’s disease-related soluble aggregates detectable by single-molecule-fluorescence and super-resolution microscopy (read here)
- Trends in Incident Dementia Diagnosis Before and After Risk Adjustment (read here)
- Polygenic Scores Point to Microglia, Astrocytes in Alzheimer’s Pathogenesis (read here)
- Cerebral organoids with chromosome 21 trisomy secrete Alzheimer’s disease-related soluble aggregates detectable by single-molecule-fluorescence and super-resolution microscopy (read here)
- Human-derived air–liquid interface cultures decipher Alzheimer’s disease–SARS-CoV-2 crosstalk in the olfactory mucosa (read here)
- Infection with stomach bacteria may increase risk of Alzheimer’s disease (read here)
- Stigma and language barriers complicate treating Hispanics with Alzheimer’s disease (read here)
- Immunotherapies for Alzheimer’s disease (read here)
- How Holiday Rituals Can Comfort Grieving Family Caregivers (read here)
- How to Donate Your Brain to Science: For Dementia Families, It’s a Complex Process (read here)
- Saliva: A means to detect pain in people with dementia (read here)
- CSIRO tools used to discover two new genetic variants for Alzheimer’s disease (read here)
- A new study that links specific personality traits to dementia risk could open the door for new approaches to prevention and treatment. (read here)
- Are T Cells to Blame for Cognitive Impairment Caused by Hypertension? (read here)
- Oligodendrocytes and neurons contribute to amyloid-β deposition in Alzheimer’s disease (read here)
- How CRISPR gene editing could help treat Alzheimer’s (read here)
- Clues to preventing Alzheimer’s come from patient who, despite genetics, evaded disease (read here)
- Using deep long-read RNAseq in Alzheimer’s disease brain to assess medical relevance of RNA isoform diversity (read here)
- Nanoparticle-delivered RNA reduces neuroinflammation in lab tests (read here)
- Study Reveals a Protein Called Snail May Play a Role in Healing Brain Injury (read here)
- Alzheimer’s in one sibling raises risk of shortened lifespan in others (read here)
- Dysfunctional muscle mitochondria linked to higher dementia risk (read here)
- Studies have ramifications for Alzheimer’s drug development, immunotherapies (read here)
- Could visiting a museum be the secret to a healthy life? (read here)
- Study Shows How Sex Differences Play a Role in Alzheimer’s (read here)
- Changes in the Diagnostic Process of Alzheimer Disease: A New Era of Blood-Based Approaches (read here)
- Researchers Determine Structural Basis for ApoE-Aβ Interactions (read here)
- Preparing for a new chapter: disease modifying treatments for early Alzheimer’s disease (read here)
- Study Suggests Serotonin Loss May Contribute to Cognitive Decline in the Early Stages of Alzheimer’s Disease (read here)
- Could fasting reset the body’s clock and protect the brain against Alzheimer’s? (read here)
- More people with dementia opting to age in place over senior living (read here)
- Light Therapy Shines in Treating Alzheimer’s Sleep and Mood Issues (read here)
- Why do some older adults show declines in their spatial memory? (read here)
- TAF15 amyloid filaments in frontotemporal lobar degeneration (read here)
- Twice daily electrical stimulation may boost mental processes in Alzheimer’s disease (read here)
- HKBU-led research develops novel drug delivery system for Gouteng compound for Alzheimer’s disease treatment (read here)
- New Alzheimer Europe publication highlights continuing inequalities in access to dementia care and treatment across Europe (read here)
- Study reveals dementia patients may benefit from listening to personalized music (read here)
- Immune Protein May Induce Dementia Unrelated to High Blood Pressure (read here)
- Efficacy and Safety of Cilostazol in Mild Cognitive Impairment (read here)
- Salty immune cells surrounding the brain linked to hypertension-induced dementia (read here)
- Desperate Families Search for Affordable Home Care (read here)
- Housing Instability Tied to Higher Risk for Dementia Diagnosis (read here)
- Longitudinal Sleep Patterns and Cognitive Impairment in Older Adults (read here)
- Efficacy and Safety of Cilostazol in Mild Cognitive Impairment (read here)
- Music compensates for altered gene expression in age-related cognitive disorders (read here)
- Hypertensive disorders of pregnancy and the risk of dementia: a systematic review and meta-analysis of cohort studies (read here)
- Two New p-Tau217 Blood Tests Join a Crowded Field (read here)
- Dementia and Postoperative Delirium in Surgical Hip Fracture Patients: Unveiling Contrasting Risk Factors and Implications (read here)
November, 2023 News
Acadia Pharmaceuticals initiates Phase 2 clinical trial for treatment of Alzheimer’s disease psychosis
Acadia Pharmaceuticals Inc. has announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP), for which there is a large unmet medical need and no FDA-approved medication. Of the more than 6.5 million people in the United States living with Alzheimer’s disease, approximately 30% will experience psychosis, commonly consisting of hallucinations and delusions. The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo. The primary endpoint is change from baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions sub-scales (SAPS-H+D) total score at Week 6. The clinical trial sites will enroll seamlessly from Phase 2 into Phase 3. Each of the planned Phase 3 studies will enroll approximately 378 patients with ADP. Patients who complete the study will have the option of participating in a long-term open-label extension study. ACP-204 works primarily as an inverse agonist at the 5-HT2A receptor. For more information about this study contactmedicalinformation@acadia.com.
CMS issues final rule on ownership of nursing facilities
The Centers for Medicare & Medicaid Services (CMS) has released a final rule, “Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Medicare Providers’ and Suppliers’ Disclosure of Private Equity Companies and Real Estate Investment Trusts,” that will implement portions of section 6101 of the Affordable Care Act, requiring the disclosure of certain ownership, managerial, and other information regarding nursing homes. The final rule also defines the terms “private equity company” and “real estate investment trust,” about which information must be disclosed on the Medicare enrollment application. Section 6101(a) of the Affordable Care Act added section 1124(c) to the Social Security Act, establishing requirements for the disclosure of information about nursing home ownership and oversight. Although nursing homes currently must report certain ownership and management data to CMS and the states as part of the Medicare and Medicaid enrollment processes, some of the information under section 1124(c) of the Act previously has not had to be disclosed (e.g., persons who merely furnish cash management services to a skilled nursing facility that is enrolling in Medicare). According to CMS, this additional data will give CMS and the states a more complete background on the organizations and individuals that own, oversee, and facilitate the operations of nursing homes. For additional details, see the CMS statement.
FDA issues final rule on direct-to-consumer prescription drug ads
The U.S. Food and Drug Administration (FDA) has published the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule.” The final rule establishes standards to implement the statutory requirement that certain direct-to-consumer human prescription drug television and radio ads present the drug’s major side effects and contraindications, known as the “major statement,” in a clear, conspicuous, and neutral manner. The standards under the rule include:
- The information uses consumer-friendly language and terms that are easily understandable.
- The audio information in the major statement is at least as understandable as the audio information in the rest of the ad.
- In ads in TV format, the information is presented concurrently using both audio and text (dual modality); to achieve dual modality
- Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio; and
- The text is displayed for a sufficient duration to allow it to be read easily. (For purposes of this standard, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio.)
- In ads in TV format, the information in text is formatted so the information can be read easily.
- The ad does not include audio or visual elements when the major statement is presented that can interfere with understanding the major statement.
Senate confirms new NIH Director
The Senate has confirmed President Biden’s nominee, Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH) in a bipartisan vote. Earlier this year, the LEAD Coalition joined 114 organizations in a letter to Senate leadership urging Dr. Bertagnolli’s confirmation. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Immediately prior to taking office as NIH Director on November 9, Dr. Bertagnolli served as Director of the National Cancer Institute (NCI). For additional information, read the NIH statement and reporting by STAT.
LEAD Coalition welcomes three new member organizations
The LEAD Coalition — the uniting voice of over 260 member and allied organizations working collaboratively to accelerate transformational progress in care and support to enrich the quality of life of those with dementia and their caregivers, detection and diagnosis, and research leading to prevention, effective treatment, and cures — recently welcomed three new member organizations.
Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients living with Alzheimer’s disease (AD) and related neurodegenerative disorders. ALZ-801 (valiltramiprosate) is an investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD. It is designed to block the formation of neurotoxic soluble beta amyloid oligomers causing cognitive decline in Alzheimer’s patients.
Founded in 1988, the National Association of Chronic Disease Directors (NACDD) is a national, nonprofit, professional association that works to improve public health by strengthening state-based leadership and expertise for chronic disease prevention and control in State, Local, Tribal, and Territorial Health Departments. The Association provides a national forum for chronic disease and health promotion professionals. NACDD’s core membership is composed of the 59 State and Territorial Health Department Chronic Disease Directors and their staff who protect the health of the public through primary and secondary prevention efforts and work “upstream” on root causes of chronic conditions. In addition, NACDD unites 7,000 chronic disease professionals across the United States working in state, tribal, and territorial health departments, nonprofits, academia, and the private industry to promote health and to reduce the burden of chronic disease.
Positrigo is a pioneer in nuclear medical imaging technologies. Headquartered in Zurich, Switzerland, the medical device company was founded in 2018 as a spin-off of ETH Zurich. Positrigo’s technology, development, clinical testing and commercialization has been supported by various private investors, the Swiss government and the European Innovation Council. NeuroLF – the company’s first device – is an ultra-compact brain Positron Emission Tomography (PET) scanner which has applications in the assessment of causes of dementias, such as Alzheimer’s disease and other brain related disorders.
PHCOE on Dementia Caregiving releases new resources
The Public Health Center of Excellence (PHCOE) on Dementia Caregiving has released two new resources. A Guide on Advanced Care Planning Resources: For People Living with Dementia and Their Care Partners contains a range of tools, materials, and information related to advanced care planning, including financial, housing, medical, legal, and palliative/hospice care assistance. The guide is intended to be used primarily by people living with dementia and their care partners to help navigate and provide recommendations for effective care, services, and considerations at various stages of cognitive impairment and dementia. Public health agencies may use this guide to raise awareness and promote the use of best practices by distributing the guide to local community organizations, healthcare systems, aging services providers, and health departments for use by their constituents.
Public Health Strategies in Dementia Caregiving: A Toolkit for Public Health Agencies is designed to provide strategies and interventions that public health agencies can implement to support and elevate the work of family dementia caregivers that are consistent with the Healthy Brain Initiative Road Map. The toolkit may be useful for all public health agencies as they set and pursue their dementia caregiving goals, but especially to public health departments that were awarded funding through the BOLD Infrastructure for Alzheimer’s Act as they implement their Alzheimer’s disease and related dementias (ADRD) strategies.
KFF publishes Medicare Advantage 2024 Spotlight
The Kaiser Family Foundation (KFF) has released the issue brief, “Medicare Advantage 2024 Spotlight: First Look,” detailing the organization’s analysis of Medicare Advantage (MA) plans and Part D prescription drug plans (PDPs) available in 2024. According to the analysis, the typical beneficiary has a choice of 43 MA plans as an alternative to traditional Medicare in 2024. This is the same number as in 2023 but more than twice the number of plans that were offered in 2018. Of the 43 MA plans, 36 plans offer Part D drug coverage, on average. Additionally, individuals with traditional Medicare have a choice of 21 Medicare stand-alone PDPs for 2024. The number of D-SNPs (for dually-eligible beneficiaries) has increased substantially over the past five years, nearly doubling from 465 dual SNPs in 2019 to 851 dual SNPs in 2024. Most Medicare Advantage plans are offering extra benefits, such as vision, dental and hearing as they have in previous years. Most Medicare Advantage plans are not offering Special Supplemental Benefits for the Chronically Ill, which are extra benefits available to a subset of a plan’s enrollees, that are not primarily health related, and are specifically for chronically ill beneficiaries. However, more SNP plans than individual plans generally offer these benefits, particularly food and produce (60.0% in SNPs compared to 13.9% in individual plans).
High biological age may increase the risk of dementia
According to results from a Karolinska Institute study, people who have a higher biological age than their actual chronological age have a significantly increased risk of stroke and dementia, especially vascular dementia. The increased risk persists even if other risk factors — such as genetics, lifestyle and socioeconomics — are taken into account. To measure biological age and the link to disease, the researchers used data from the UK Biobank. The study examined a cohort of 325,000 people who were between 40 and 70 years old at the time of the first measurement. Biological age was calculated using 18 biomarkers, including blood lipids, blood sugar, blood pressure, lung function and body-mass index. The researchers then investigated the relationship between these biomarkers and the risk of developing neurodegenerative diseases within a nine-year period. When compared to chronological age, high biological age was linked to a significantly increased risk of dementia, especially vascular dementia, and ischemic stroke.
Additional Reads
- Neuronanomedicine for Alzheimer’s and Parkinson’s disease: Current progress and a guide to improve clinical translation (read here)
- Screening, Assessment, and Pharmacologic Treatment of Mild Cognitive Impairment and Early Alzheimer’s Disease: The Role for Monoclonal Antibodies (read here)
- Dancing Through Dementia: How Movement Aids Memory and Mood (read here)
- Can Health, Lifestyle Changes Protect Elders from Alzheimer’s? (read here)
- Irritability, Agitation and Anxiety in Alzheimer’s Patients Caused by Brain Inflammation, Pitt Study Says (read here)
- Many Americans with dementia can’t get the hospice care they need (read here)
- Alzheimer’s activist Rebecca Chopp recommends testing early for the disease (read here)
- Older adults’ awareness of modifiable risk and protective factors for dementia and interest in eHealth interventions for brain health: a comparison between the Netherlands and Germany (read here)
- Size of brain area linked with cognitive decline – even in people with no other warning signs of Alzheimer’s disease (read here)
- Lowering a form of brain cholesterol reduces Alzheimer’s-like damage in mice (read here)
- Eating More Whole Grains Is Associated With Less Memory Decline in African Americans (read here)
- Applying An Evidence-Based Approach To Comprehensive Dementia Care Under The New GUIDE Model (read here)
- Understanding Donanemab’s Clinical Relevance for Patients With Alzheimer Disease (read here)
- Research finds sex differences in immune response and metabolism drive Alzheimer’s disease (read here)
- Documentary offers empowered approach to dementia and Alzheimer’s disease (read here)
- Social and Behavior Factors of Alzheimer’s Disease and Related Dementias: A National Study in the U.S (read here)
- Food Insecurity, Memory, and Dementia Among US Adults Aged 50 Years and Older (read here)
- Hearing Loss is Associated with Subtle Changes in the Brain (read here)
- Black Patients Less Likely to Receive Alzheimer’s Care, Blocking Access to New Treatments (read here)
- Early study results show virtual reality can bolster caregivers, LTC seniors relationship (read here)
- A Promising Turning Point For Dementia Care: The GUIDE Model (read here)
- How a mutation in microglia elevates Alzheimer’s risk (read here)
- Lab-grown ‘small blood vessels’ point to potential treatment for major cause of stroke and vascular dementia (read here)
- “May the Force (and Size) Be with You”: Muscle Mass and Function Are Important Risk Factors for Cognitive Decline and Dementia (read here)
- Dissociable Effects of Alzheimer’s Disease-Related Cognitive Dysfunction and Aging on Functional Brain Network Segregation (read here)
- Could newborn neurons reverse Alzheimer’s? (read here)
- Gut inflammation associated with age and Alzheimer’s disease pathology: a human cohort study (read here)
- Adult Children Discuss the Trials of Caring for Their Aging Parents (read here)
- Facing Financial Ruin as Costs Soar for Elder Care (read here)
- As the workforce ages, now is the time to normalize dementia care (read here)
- This Wireless, Handheld, Non-invasive Device Detects Alzheimer’s and Parkinson’s Biomarkers (read here)
- Unlocking Blood-Brain Barrier Boosts Immunotherapy Efficacy, Lowers ARIA (read here)
- Lowering blood pressure significantly reduced dementia risk in people with hypertension (read here)
- AI that reads brain scans shows promise for finding Alzheimer’s genes (read here)
- Dysfunctional muscle mitochondria linked to higher dementia risk (read here)
- Recognizing Advanced Alzheimer’s: Signs, Support, and Care (read here)
- Constricting Life Space and Neurodegenerative Disease in Community-Dwelling Older Men (read here)
- Researchers identify new criteria to detect rapidly progressive dementia (read here)
- Scientists tame biological trigger of deadly Huntington’s disease (read here)
- Treat Before ‘Aβ Bothers Tau,’ Scientists Say at CTAD (read here)
- Alzheimer’s Disease and Weight Loss: Why It Happens and What Can Be Done (read here)
- Pharmacogenomics holds promise for personalized dementia therapies (read here)
- Accelerating development of next-generation drugs for Alzheimer’s and related dementias (read here)
- New Culprit in Amyloid Beta Accumulation and Neurodegeneration (read here)
- PET scans may predict Parkinson’s disease and Lewy body dementia in at-risk individuals (read here)
- This dementia-inclusive choir is a happy place for friends and carers (read here)
- The Arts and Advanced Dementia (read here)
- Alzheimer’s Disease: Genetic Variant Can Significantly Raise Risk (read here)
- Agitation That May Happen with Dementia Due to Alzheimer’s Disease (read here)
- Reducing poverty may reduce risk of developing dementia (read here)
- Positive Data for First and Only Treatment Approved for Agitation in Alzheimer Dementia (read here)
- Alzheimer’s Disease: The Winds of Progress (read here)
- High metabolism is an early sign of Alzheimer’s disease (read here)
- America’s Message to Families With Loved Ones Suffering From Dementia: You’re on Your Own (read here)
- To Recruit for Diverse Alzheimer Trials, Go to the People (read here)
- Border Surprise: Glia Limitans Astrocytes Sit on Brain Surface (read here)
- Researchers find the roots of tau tangles in Alzheimer’s disease (read here)
- Virtual community of long-term care and other providers commits to ‘age-friendly’ care guidelines (read here)
- Sweet spot for HRT may reduce dementia risk by nearly a third, study says (read here)
- Being bilingual slows brain ageing, and can prevent Alzheimer’s (read here)
- Brain health in over 50s deteriorated more rapidly during the pandemic (read here)
- Minimum-Staffing Rules for U.S. Nursing Homes — Opportunities and Challenges (read here)
October, 2023 News
CMS removed NCD for amyloid PET to diagnose Alzheimer’s disease
The Centers for Medicare & Medicaid Services (CMS) has announced that it is removing the national coverage determination (NCD) at § 220.6.20, ending coverage with evidence development (CED) for positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors (MACs). The 2013 amyloid PET NCD had resulted in nationwide non-coverage of amyloid PET for a full decade, with the extraordinarily limited exception of coverage (one scan per lifetime) for individuals participating in CED clinical studies.
CMS revises Civil Money Penalty Reinvestment Program
The Centers for Medicare & Medicaid Services (CMS) has issued updated guidance for the Civil Money Penalty Reinvestment Program (CMPRP) for projects to support the quality of care and life for nursing home residents in long-term care facilities certified by Medicare and Medicaid. Under the program, a portion of civil money penalty (CMP) funds for noncompliance is provided to the State to reinvest in activities that will benefit residents to protect and improve their safety and quality of care. The CMPRP revised policies clarify the allowable uses of CMP funds, with maximum funding limits per nursing home and a clear list of the non-allowable uses of CMP funds.
FDA establishes advisory committee on digital health technologies
The U.S. Food and Drug Administration is establishing a new Digital Health Advisory Committee (DHAC) to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. Digital health also includes issues such as decentralized trials, patient-generated health data, and cybersecurity. The DHAC will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. FDA is accepting nominations for DHAC membership until December 11. The committee should be fully operational in 2024.
NIH revises grant review process to improve focus on scientific merit, reduce reputational bias
The National Institutes of Health (NIH) is taking steps to simplify its process to assess the scientific merit of research grant applications and mitigate elements that have the potential to introduce bias into review. The changes will help reviewers focus on the potential for proposed research to advance scientific knowledge and improve human health. Previously, five criteria were scored individually using a common scale. The simplified review framework reorganizes these criteria into three factors; importance of research along with rigor and feasibility will be scored using a common scale while expertise and resources will be evaluated for sufficiency only and not given a numeric score. The simplified review framework will be implemented for grant applications received on or after Jan. 25, 2025.
NIH has been gathering significant feedback from the extramural community on the grant application review process, and last year NIH proposed revisions to the process through a Simplified Framework for NIH Peer Review Criteria initiative. In forming the simplified framework, NIH gathered input through a 2022 Request for Information, receiving more than 800 responses from individuals and scientific societies. Most responses were supportive of the proposed changes, and underscored the need for communication, guidance and resources well in advance of implementation.These changes contribute to NIH’s decade long effort to address potential bias in grantmaking and enable a level playing field. Additionally, these changes will reduce administrative responsibilities of peer reviewers, shifting them to NIH staff, thereby allowing reviewers to focus on the science. NIH is developing a timeline, policy rollout and trainings to support implementation of these changes. Additionally, NIH will compile feedback and conduct data analysis to evaluate the changes over time, allowing for additional modifications as necessary.
New educational resources on dementia diagnosis and treatment in surgical settings
The American College of Surgeons (ACS) recently released a suite of educational resources focused on the accurate, consistent diagnosis and appropriate treatment of dementia and cognitive impairment to promote patient safety, equitable care, and decreased hospital resource use. Resources include:
- Cognitive Impairment Screening – ACS House of Surgery Podcast: This episode features a multidisciplinary panel of experts discussing the importance of preoperative detection of cognitive impairment and dementia in the geriatric population.
- Patient and Caregiver Brochure: This brochure for patients and caregivers covers what to expect when having surgery and includes shared decision-making and treatment choice options based on conditions and surgical needs of patients.
- ACS Bulletin Article: Cognitive Screening in Older Patients May Help Optimize Outcomes: Among older surgical patients, cognitive impairment prior to surgery is prevalent and substantially increases the risk of costly and serious postoperative complications and further cognitive decline. This neurocognitive dysfunction introduces crucial factors into the surgical decision-making process and perioperative care planning, which has a wide-ranging impact on surgeons, patients, caregivers, and other members of the healthcare team.
- Toolkit: Designed for interdisciplinary teams caring for older adults undergoing surgery, this best-practice toolkit covers why preoperative cognitive assessments are important, how to talk to patients about screening cognition, a detailed overview of some varying validated screening tools currently available, and next steps section for when patients screen positive.
- The Impact of Cognitive Impairment on Surgical Decision-Making and the Care Process: Held at the 2023 ACS Quality & Safety Conference, this session featured a panel of experts discussing varying levels of dementia and the importance of screening for cognition in the preoperative setting, processes that can help a physician and patient move beyond passive informed consent to a more collaborative, patient-centered experience, and the pearls and pitfalls of advanced directives.
GAO examines use of CMS data to identify private equity ownership of nursing homes
The U.S. Government Accountability Office (GAO) recently conducted an analysis examining the complexities of using data from the Centers for Medicare & Medicaid Services (CMS) to identify ownership structures within nursing homes, with a particular focus on private equity ownership. The study highlights complexities in nursing home ownership structures and the limitations of CMS data, emphasizing the difficulty in accurately identifying private equity ownership. The report also discusses the implications of these limitations on transparency and oversight within the nursing home industry. To perform this analysis, GAO adopted a comprehensive approach, including reviewing nursing home ownership data from CMS and other sources, examining relevant documentation and research studies, and conducting interviews with CMS officials. to read one page summary and the full GAO analysis.
ADvancing States launches dementia training course
ADvancing States has launched a training course “Identifying and Understanding the Needs of People Living with Dementia and Their Caregivers,” developed in partnership with the Alzheimer’s Association. The course will further participants’ understanding of Alzheimer’s disease and other forms of dementia, and what differentiates these conditions from typical aging. Participants will learn communication strategies to provide telephone support to someone living with early-stage dementia. The course describes the impact that dementia can have on caregivers in order to prepare community resource professionals for empathetic phone interactions. Participants will strengthen their knowledge of resources to assist individuals and caregivers through learning about the role of the Alzheimer’s Association and the support that it offers to those affected by Alzheimer’s and other dementia. To access this free training course, visit the Consumer Access to Services course category on ADvancing States iQ.
ASTHO publishes best practice guide for falls prevention
the Association of State and Territorial Health Officials (ASTHO), with support from the Centers for Disease Control and Prevention (CDC), has published “Expanding Falls Prevention Through Surveillance, Community-Clinical Linkages, and Strategic Planning and Evaluation,” to address the public health impact of unintentional falls among older adults. The guide is intended to be a comprehensive resource for state health departments in understanding how to align current falls prevention efforts to support community-clinical linkages and offer strategies to assist in implementing new efforts to support these linkages.
Unintentional falls are the leading cause of injury and injury death among older adults in the United States. Each year, about 14 million older adults report falls and five million report fall injuries, leading to over $50 billion in medical costs. Older adult falls contribute to more than 900,000 hospitalizations every year. A fall-related hospitalization increases the likelihood of a long-term nursing home admission, creating either a temporary or permanent loss of independence. In 2021, there were nearly 39,000 fall-related deaths among older adults, averaging more than 100 deaths per day.
Chlorhexidine bathing routine reduces infections in nursing homes
According to a study in the New England Journal of Medicine, nursing homes using a chlorhexidine antiseptic soap bathing routine to clean the skin and nose with over-the-counter antiseptic solutions prevents serious infections and reduces the amount of antibiotic resistant organisms, such as methicillin-resistant Staphylococcus aureus (MRSA)..Annually, three million healthcare-associated infections in U.S. nursing homes cause 150,000 hospital admissions and 350,000 deaths. In the study involving nearly 14,000 residents, researchers found that nursing homes using the “decolonization” bathing routine averaged two residents per month avoiding infections that would have required transfer to the hospital. These nursing homes also reduced significantly hospital transfers due to other causes. Nursing homes that used decolonization significant reduced overall prevalence of multidrug-resistant organisms including MRSA, vancomycin-resistant Enterococci, and other bacteria.
In this 18-month study of 28 California nursing homes, researchers compared 14 facilities that continued usual bathing routines to 14 facilities that used decolonization for all residents. Decolonization included using chlorhexidine and a nasal swab with povidone-iodine (iodophor) to remove pathogens from residents’ skin and nose. These two products have been used in healthcare for over 60 years. Adherence to the decolonization bathing routine did not need to be perfect to prevent hospitalization and spread of resistant organisms: 87 percent of nursing home staff used the chlorhexidine as intended and 67 percent used the nasal swab as intended.
Additional Reads
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- Abrupt drop in blood pressure may be an early sign of dementia (read here)
- No Influence of APOE Status on Donanemab Efficacy (read here)
- Number of dementia cases could be 42% higher than previously estimated by 2040 (read here)
- Eisai Plans to Submit BLA for Subcutaneous Lecanemab After Findings Show Promising Results (read here)
- The beginning of the end for Alzheimer’s Dementia? (read here)
- Why Diagnosing Alzheimer’s Early Is So Important (read here)
- Biogen’s tau-lowering drug slows cognitive decline in early study of Alzheimer’s disease (read here)
- New studies find benefits in very early drug treatment of Alzheimer’s (read here)
- Donanemab slows disease progression, reduces amyloid in early symptomatic Alzheimer’s (read here)
- Facing dementia without a diagnosis is crushing. A new program in Kenya offers help (read here)
- Metformin Cessation and Dementia Incidence (read here)
- Do dementia villages actually work? We just don’t know (read here)
- Physicians Are Dramatically Underdiagnosing Early Cognitive Decline, a Precursor to Alzheimer’s (read here)
- Study Suggests Estrogen to Prevent Alzheimer’s Warrants Renewed Research Interest (read here)
- Validating an MRI Biomarker for Early Onset Alzheimer’s Disease (read here)
- Ensuring adequate dementia care: The beginning of the end of Alzheimer’s? (read here)
- Study on Largest Genetic Risk Factor for Alzheimer’s Points Toward New Drug Target (read here)
- Adding lifestyle coaching to treatment decreases cognitive decline in early Alzheimer’s (read here)
- Non-invasive temporal interference electrical stimulation of the human hippocampus (read here)
- Individuals Can Now Request a Blood Test for Alzheimer’s Disease: Why Some Dementia Experts Are Wary (read here)
- The Sporadic Early‐onset Alzheimer’s Disease Signature Of Atrophy: Preliminary Findings From The Longitudinal Early‐onset Alzheimer’s Disease Study (LEADS) Cohort (read here)
- Doubts abound about a new Alzheimer’s blood test (read here)
- Scientists discover links between Alzheimer’s disease and gut microbiota (read here)
- New model provides window into Alzheimer’s disease development (read here)
- We may finally know how cognitive reserve protects against Alzheimer’s (read here)
- Fluctuating blood pressure: a warning sign for dementia and heart disease (read here)
- Clinical Overview: Lecanemab Offers Hope for Patients With Alzheimer Disease (read here)
- Western researchers reveal link between Alzheimer’s disease and sex hormones (read here)
- Adults With ADHD Are at Increased Risk for Developing Dementia (read here)
- Brain fungal infection produces Alzheimer’s disease-like changes (read here)
- Dementia’s financial and family impact: New study shows outsized toll (read here)
- A New Framework for Dementia Nomenclature (read here)
- Deep learning combining FDG-PET and neurocognitive data accurately predicts MCI conversion to Alzheimer’s dementia 3-year post MCI diagnosis (read here)
- In Alzheimer’s, Tau Oligomers in Synapses Act as ‘Eat Me’ Signal (read here)
- Scientists Investigating Alzheimer’s Drug Faulted in Leaked Report (read here)
- Medicare to cover more brain scans related to Alzheimer’s drugs (read here)
- Taking a deep dive into the Alzheimer’s brain in search of understanding and new targets (read here)
- $151M Grant Will Drive New Era in Alzheimer’s Treatments (read here)
- Blood tests needed for widespread Alzheimer’s diagnosis on the way (read here)
- Can we prevent Alzheimer’s? Scientists say new tests and treatments are “a game changer” (read here)
- Bracing for a cloudy NIA budget forecast (read here)
- Certain navigational mistakes could be early signs of Alzheimer’s disease (read here)
- Dementia risk factors pose more danger for ethnic minorities, finds study (read here)
- Advanced imaging may shed light on mechanisms behind Alzheimer’s disease (read here)
- Understanding the Onset of Sporadic Alzheimer’s Disease (read here)
- It May Not Be So Typical: Distinguishing Frontotemporal Dementia From Behavioral Variant Alzheimer’s Disease (read here)
- Is the Eye the Window to Alzheimer’s? (read here)
- Insight: Down syndrome families’ fight for access to Alzheimer’s trials, treatments (read here)
- Mount Sinai Researchers First to Develop Age Prediction Model on Human Brain Tissue Using Artificial Intelligence (read here)
- Study Published by NYMC Researchers in Nature Communications Biology Unveils Crucial Link Between Diet, Inflammation and Alzheimer’s Disease (read here)
- The gene expression changes behind Alzheimer’s disease (read here)
- Could a Faulty Ubiquitin Trigger Amyloid and Tau Deposits? (read here)
- Stunning Detail: Single-Cell Studies Chart Genomic Architecture of AD (read here)
- Possible tool discovered to diagnose common contributor to vascular dementia (read here)
- New AI Technique Helps Find Alzheimer’s Drug Targets (read here)
- Even Moderate Drinking May Be Bad for Brain Health (read here)
- Are people who have long-haul COVID more at risk for Alzheimer’s? (read here)
- Protein that could help defeat Alzheimer’s and increase productive lifespan (read here)
- Study maps brain wave disruptions affecting memory recall (read here)
- Proton pump inhibitors and dementia: A nationwide population‐based study (read here)
- Scientists discover neurons that act as brain ‘glue’ to recall memories (read here)
- Multivariate GWAS of Alzheimer’s disease CSF biomarker profiles implies GRIN2D in synaptic functioning (read here)
- Graphene oxide reduces the toxicity of Alzheimer’s proteins (read here)
- Antibody Therapy Inspired by Patient Case Reduced Tau Tangles in a Preclinical Model of Alzheimer’s Disease (read here)
- Caregiving Through Dementia: a Loving and Difficult Journey (read here)
- Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial (read here)
- Study indicates possible link between chronic stress and Alzheimer’s disease (read here)
- In Forming Long-Term Memories, Vascular Cells are Crucial (read here)
- Parkinson’s Research Buoyed by Alzheimer’s Advances (read here)
- Effect of Periodontal Disease on Alzheimer’s Disease: A Systematic Review (read here)
- Promoting Equity In Clinical Decision Making: Dismantling Race-Based Medicine (read here)
- Caregiver burden in a home hospital versus traditional hospital: A secondary analysis of a randomized controlled trial (read here)
September, 2023 News
288 LEAD Coalition members and allies urge Congress to pass the CHANGE Act
NIH designates people with disabilities as a population with health disparities
On September 26, Eliseo J. Pérez-Stable, M.D., director of the National Institute on Minority Health and Health Disparities (NIMHD), designated people with disabilities as a population with health disparities for research supported by the National Institutes of Health. The decision was made in consultation with Robert Otto Valdez, Ph.D., the director of the Agency for Healthcare Research and Quality, after careful consideration of a report delivered by an NIMHD advisory council, input from the disability community and a review of the science and evidence. A separate report issued in December 2022 by the Advisory Committee to the (NIH) Director (ACD), informed by the work of the Subgroup on Individuals with Disabilities, explored similar issues faced by people with disabilities. The designation is one of several steps NIH is taking to address health disparities faced by people with disabilities and ensure their representation in NIH research. NIH also issued a notice of funding opportunity calling for research applications focused on novel and innovative approaches and interventions that address the intersecting impact of disability, race and ethnicity, and socioeconomic status on healthcare access and health outcomes. NIH also recently issued a Request for Information (RFI) inviting feedback on a proposed update to the NIH mission statement; see the LEAD Coalition’s Take Action page for details on the Mission Statement RFI).
NIMHD is the lead NIH institute on monitoring minority health and health disparities research. Designated populations experience significant disparities in their rates of illness, morbidity, mortality and survival, driven by social disadvantage, compared to the health status of the general population. A health disparity designation helps to encourage research specific to the health issues and unmet health needs of these populations. Other NIH-designated populations with health disparities include racial and ethnic minority groups, people with lower socioeconomic status, underserved rural communities and sexual and gender minority groups.
NIA launches next EUREKA Challenge
The National Institute on Aging (NIA recently announced raw the Pioneering Research for Early Prediction of Alzheimer’s and Related Dementias EUREKA (PREPARE) challenge prize to improve early detection and address diagnosis gaps among racial and ethnic groups that are underrepresented in most clinical studies and databases. To make progress, the challenge aims to address the need for:
- Data from a wider set of sources and types, including data relevant to low-resourced, underserved communities disproportionately impacted by Alzheimer’s disease and related forms of dementia (AD/ADRD) to better understand and address biases in existing data sources;
- Open, shareable data, stored in trusted repositories to determine “distributional robustness” of predictive algorithms; and
- Algorithms that meet “right to explanation” mandates (i.e., if an AI algorithm impacts people, people have a right to an explanation of how AI conclusions were reached).
For additional details about the PREPARE challenge, eligibility, and application instructions, click here.
FDA updates FAQ and issues guidance on advancing real world evidence
The U.S. Food and Drug Administration (FDA) has updated the FAQ about its Advancing Real-World Evidence (RWE) Program. The Program seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements. The Program fulfills an FDA commitment under the Prescription Drug User Fee Act (PDUFA) VII. FDA also has released guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” For a summary of the new guidance, click here.
ACL awards Center of Excellence to align health and social care
The Administration for Community Living (ACL) Office of Network Advancement (ONA) has announced a new award to USAging for the Center of Excellence (COE) to Align Health and Social Care: Enhancing Community-Based Aging and Disability Organizations to Improve Access to Long-Term Services and Supports. The project period runs through August 31, 2026. First-year funding will support development and enhancement of aging and disability organizations supported by ACL to operate as community care hubs (CCHs). A CCH is a community-focused entity that organizes and supports a network of community-based organizations providing services to address health-related social needs, typically as partners with health care or heath system providers.
Through this award, the COE will collaborate with relevant stakeholders to improve access to long-term services and supports through CCHs as part of a broader No Wrong Door (NWD) System. In this first year, the COE will administer and manage competitive sub-awards to an estimated 20 disability and aging organizations to improve their NWD access functions, with specific emphasis on the core function of care transitions and CCH capacity to coordinate referrals across health care and social services, as well as supporting individuals transitioning from hospital to home. The COE will collaborate with ACL and partners to provide technical assistance to support both new and existing CCHs, with an emphasis on organizations in ACL’s aging and disability networks. The COE also will participate in an evaluation designed by ACL’s Office of Performance and Evaluation to assess the impact of CCHs on the delivery and coordination of services that address health-related social needs.
ACL awards Innovation Lab grant to improve falls prevention
The Administration for Community Living (ACL) Office of Performance and Evaluation has announced the creation of the ACL Innovation Lab through an award to the National Council on Aging. The three-year grant will support a collaborative, multi-partner effort to build knowledge and advance fall prevention efforts across the nation. The Lab will conduct research, demonstrations, and evaluations pertaining to falls prevention among older adults, including older adults with disabilities. The award will expand ACL’s existing falls prevention efforts, advancing and disseminating knowledge and practices that prevent falls and address risk factors. The Lab’s primary goals and activities include:
- Developing a taxonomy for falls prevention research.
- Funding a cohort of sub-awards to community-based entities nationwide to conduct research to understand and measure the extent to which existing interventions reduce falls and risk factors.
- Developing a secure, dynamic system to house the data collected and evidence developed by sub-awardees.
- Serving as a national focal point for technical assistance that supports the delivery and scaling of effective falls prevention interventions across the aging network.
CMS to hold Medicare Drug Price Negotiation Program listening sessions
The Centers for Medicare & Medicaid Services (CMS) plans to host a series of patient-focused virtual listening sessions for the Medicare Drug Price Negotiation Program. The sessions are intended to provide opportunities for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations. CMS will host 10 Listening Sessions this fall, one for each of the 10 selected drugs:
- Eliquis: Monday, October 30, 12:00 – 1:30 PM EST
- Enbrel: Tuesday, October 31, 12:00 – 1:30 PM EST
- Entresto: Wednesday, November 1, 12:00 – 1:30 PM EST
- Farxiga: Thursday, November 2, 12:00 – 1:30 PM EST
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill: Friday, November 3, 12:00 – 1:30 PM EST
- Imbruvica: Monday, November 6, 12:00 – 1:30 PM EST
- Januvia: Tuesday, November 7, 12:00 – 1:30 PM EST
- Jardiance: Wednesday, November 8, 12:00 – 1:30 PM EST
- Stelara: Tuesday, November 14, 12:00 – 1:30 PM EST
- Xarelto: Wednesday, November 15, 2:00 – 3:30 PM EST
The sessions are open to the public and will be live streamed. Registration is not necessary to view the livestream. Registration by October 2 is required to make a public statement at one or more of the virtual listening sessions. Because there are limited speaking opportunities during the sessions, CMS encourages the public to submit written input by the October 2 deadline, if interested, in response to the 2023 CMS information collection request about selected drugs and evidence about alternative treatments. Submissions can include data on the selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical need and impacts on specific populations as well as the patient/caregiver experience.
KFF issue brief examines what share of nursing facilities might meet CMS proposed staffing standards
On September 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule (CMS 3442-P) that would create new requirements for nurse staffing levels in nursing facilities. An earlier report by the National Academy of Sciences, Engineering, and Medicine (NASEM) raised concerns about low nursing staff levels in nursing facilities and the impact on the quality of care for nursing home residents. In response to the CMS proposed rule, Kaiser Family Foundation has published an issue brief analyzing the percentage and characteristics of facilities that would meet the proposed requirements for the minimum number of registered nurse and nurse aide hours. The analysis does not evaluate facilities’ ability to comply with other proposed requirements, including the requirement to always have a registered nurse on duty 24/7 or the ability to meet the new reporting and assessment requirements due to data limitations. The analysis uses Nursing Home Compare data, which include 14,591 nursing facilities (97% of all facilities, serving 1.17 million or 98% of all residents) that reported staffing levels in August, 2023. KKF found that:
- Among all nursing facilities, fewer than 20% currently could meet the required number of hours for registered nurses and nurse aides, meaning that over 80% of facilities would need to hire nursing staff.
- 90% of for-profit facilities would need to hire additional nursing staff compared with 60% of non-profit and government facilities.
- The percentage of nursing facilities that would meet the requirements in the proposed rule varies from all in Alaska (100%) to nearly none in Louisiana (1%).
Interest parties may submit public comments to CMS on the proposed rule by the November 6 deadline. Additional information about the public comment opportunity is available on the LEAD Coalition Take Action web page until the comment deadline.
ADI releases World Alzheimer’s Report 2023
Alzheimer’s Disease International has released World Alzheimer Report 2023, which focuses on reducing the risk of dementia and offers a global insight into the ways in which dementia risk factors are experienced. The report examines modifiable and non-modifiable risk factors as well as the benefits of lifelong risk reduction. The report highlights global disparities in an individual’s ability and means to mitigate their risk of dementia, and includes a call to action for governments to provide population-based systemic changes to promote risk reduction and the importance of dementia research. For additional insight, watch the archived webinar.
Additional Reads
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- Specific interneurons are important in aging-associated cognitive decline, study finds (read here)
- Decoding the complexity of Alzheimer’s disease (read here)
- Sitting all day increases dementia risk — even if you exercise (read here)
- “Anti-tangle” molecule could aid search for new dementia treatments, say scientists (read here)
- Ten-year plan to fill dementia knowledge gaps (read here)
- Exploring the Association Between Opioid Use Disorder and Alzheimer’s Disease and Dementia Among a National Sample of the U.S. Population (read here)
- Researchers Connect Alzheimer’s-Associated Genetic Variants with Brain Cell Function (read here)
- Researchers discover how a gene only some of us have may protect against neurodegeneration (read here)
- Meet the Two New Biomarker Candidates for Lewy Body Diseases (read here)
- Researchers find success with stem cell therapy in mice model of Alzheimer’s disease (read here)
- How do toxic proteins accumulate in Alzheimer’s and other diseases? (read here)
- Hypertension and Stroke as Mediators of Air Pollution Exposure and Incident Dementia (read here)
- New research reveals link between finger tapping and Alzheimer’s (read here)
- When Faced with Amyloidosis, Human Transplants Die by Necroptosis (read here)
- ‘A Profound Change’: New Guidelines Proposed for Diagnosing Alzheimer’s (read here)
- Mechanisms of phototherapy of Alzheimer’s disease during sleep and wakefulness: the role of the meningeal lymphatics (read here)
- Telecare Cuts Costs, Boosts Quality of Life for Dementia Patients (read here)
- Fundamental process behind memory now captured live (read here)
- Living in a disadvantaged neighborhood affects food choices, weight gain and the microstructure of the brain (read here)
- MEG3 activates necroptosis in human neuron xenografts modeling Alzheimer’s disease (read here)
- Evaluation of the Electronic Clinical Dementia Rating for Dementia Screening (read here)
- CSF Proteomic Panel Better Predicts Decline Than Do Classic AD Biomarkers (read here)
- Navigating the complexities of caregiving for dementia in South Asian communities (read here)
- Could a Breakdown in the Brain’s Networks Allow Infections to Contribute to Alzheimer’s Disease? (read here)
- New link between increased astrocytes in the brain and blood in early Alzheimer’s disease (read here)
- Researchers Create a New Window on Leading Genetic Cause of Alzheimer’s (read here)
- Large amounts of sedentary time linked with higher risk of dementia in older adults (read here)
- PLCγ2 Variants Toggle Microglial Plaque Compactors (read here)
- The High-Wire Act of Caregiving and Saving for Retirement (read here)
- Exercise-Induced Hormone Irisin May Reduce Alzheimer’s Disease Plaque and Tangle Pathology in the Brain (read here)
- Using Focused Ultrasound to Treat Alzheimer’s and Parkinson’s (read here)
- Specialized dementia care in nursing homes linked to better outcomes for residents (read here)
- Poor metabolic health could increase your risk of developing dementia later in life (read here)
- Some US airports strive to make flying more inclusive for those with dementia (read here)
- Health Care Costs Associated With Hospice Use For People With Dementia In The US (read here)
- The dementia tax (read here)
- Customize your dementia clinical trial recruitment materials with OutreachPro! (read here)
- ADscreen: A speech processing-based screening system for automatic identification of patients with Alzheimer’s disease and related dementia (read here)
- Hospital-Diagnosed Infections, Autoimmune Diseases, and Subsequent Dementia Incidence (read here)
- The Power of Food for People with Dementia (read here)
- New perspectives on understanding, preventing and treating vascular dementia (read here)
- Social isolation contributes to brain atrophy and cognitive decline in older adults, study suggests (read here)
- Emerging diagnostics and therapeutics for Alzheimer disease (read here)
- Treatments for AD: towards the right target at the right time (read here)
- Alzheimer’s Is a Terrible Disease—Especially If You’re Black (read here)
- UK researchers 1st to show multiple sclerosis drug can be used as Alzheimer’s therapy (read here)
- Unlocking how the new Alzheimer’s drug lecanemab works (read here)
August, 2023 News
CDC opens Health Brain Resource Center and repository of state and local AD/ADRD Plans
The Centers for Disease Control and Prevention (CDC) has opened its Healthy Brain Resource Center (HBRC), an easy-to-navigate website that helps users find credible public information and materials to support implementing the Healthy Brain Initiative (HBI) Road Map actions. CDC’s Alzheimer’s Disease Program also has compiled and centralized all publicly available state and jurisdiction strategic plans on Alzheimer’s disease and related dementias (ADRD). By having these plans easily accessible, states, jurisdictions, and other organizations interested in ADRD can learn what others are doing, which can foster collaboration and support engagement in priorities for action.
CDC announces new 43 BOLD capacity-building and implementation grant awardees
The Centers for Disease Control and Prevention (CDC) has announced 43 “BOLD Public Health Programs to Address Alzheimer’s Disease and Related Dementias” (CDC-RFA-DP23-0010) grant awardees. This funding is supported by the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act, Public Law 115-406. The award date is September 30. Recipients will use a public health approach to Alzheimer’s Disease and related dementias (ADRD) using CDC’s Healthy Brain Initiative State and Local Public Health Partnerships to Address Dementia: The 2023-2027 Road Map, the Road Map for Indian Country (RM Series), as well as future updates, as guides to expand and improve the response to ADRD in their jurisdictions.
Thirteen Component 1 recipients will be funded for two capacity-building years and three implementation years. During the capacity-building phase, recipients will be creating statewide dementia coalitions and developing or updating ADRD strategic plans for their jurisdictions. During the implementation phase, recipients conduct ADRD activities in line with their strategic plan and the Road Map actions. Thirty Component 2 recipients will be funded for five implementation years to conduct ADRD activities in line with their strategic plan and Road Map actions. All 43 recipients will increase awareness and understanding among the general public (including populations experiencing high burden), providers, and other professionals, about ADRD topics corresponding to primary, secondary, and tertiary prevention. Recipients will address the social determinants of health (SDOH) to achieve health equity goals including but not limited to the improvement of community-clinical linkages among health care systems and existing services, public health agencies, and community-based organizations. For the full list of recipients, along with additional project details as they become available, click here.
CMS announces GUIDE comprehensive dementia care model
On July 31, the Centers for Medicare & Medicaid Services (CMS) announced its Guiding an Improved Dementia Experience (GUIDE) Model — a package of care coordination and management, caregiver education and support, and respite services — which aims to improve the quality of life for people living with dementia, reduce strain on unpaid caregivers, and help people remain in their homes and communities. GUIDE will be tested nationwide from 2024-2032 as a voluntary alternative payment model (APM) through the CMS Center for Medicare and Medicaid Innovation (CMMI). Qualified participating health care providers will deliver comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. Under the GUIDE model, people with dementia and their caregivers will have access to a care navigator who will help them access services and supports, including clinical services and non-clinical services such as meals and transportation through community-based organizations. Prior to CMS releasing the application this autumn, interested organizations are encouraged to submit Letters of Intent to CMS by September 15. Providers eligible to be GUIDE participants are Medicare Part B-enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model. If an applicant cannot meet the GUIDE care delivery requirements alone, they may contract with another Medicare provider/supplier to meet the care delivery requirements. For additional information, see the GUIDE Model Fact Sheet , FAQ, press release, and sign up for the August 10 CMS GUIDE webinar.
CMS extends through September 2027 the Medicaid HCBS mandatory spousal impoverishment provisions
On August 15, the Centers for Medicare & Medicaid Services (CMS) released an informational bulletin notifying states that mandatory financial eligibility rules (spousal impoverishment provisions) for married applicants and beneficiaries eligible for home- and community-based services (HCBS) in Medicaid are extended to September 30, 2027. Under the Medicaid spousal impoverishment provisions, a certain amount of the couple’s combined resources is protected for the spouse living in the community. The extension helps married individuals seek coverage of certain long-term services and supports they need to stay healthy.
NIH releases FY 2025 Professional Judgement Budget and 2023 Scientific Progress Report
- Epidemiology/Population Studies
- Disease Mechanisms
- Diagnosis, Assessment, & Disease Monitoring
- Translational Research & Clinical Interventions
- Dementia Care & Impact of Disease
- Research Resources
ACL awards new Lifespan Respite Care Program grants
BOLD PHCOE Dementia Risk Reduction Summit recordings available
The Alzheimer’s Association BOLD Public Health Center of Excellence (PHCOE) on Dementia Risk Reduction recently held its Risk Reduction Summit at the Centers for Disease Control and Prevention (CDC). The Summit convened public health officials, researchers, and academics to identify what public health agencies at the state, local, and tribal levels can do to address dementia risk factors across the prevention spectrum. All sessions were recorded and now are available to view (YouTube). PDF presentations also are available. For additional information about the Summit or the PHCOE’s work, please contact centerofexcellence@alz.org.
Study defines disparities in memory care
NASEM publishes consensus framework on equity in health and medicine innovation
PCORI seeks applications for research on healthy aging
The Patient-Centered Outcomes Research Institute (PCORI) will open a funding opportunity entitled Healthy Aging: Optimizing Physical and Mental Functioning Across the Aging Continuum on September 6. PCORI will solicit applications for comparative clinical effectiveness research studies on different phases of the aging continuum that aim to achieve one or more of the following goals:
- Maintaining function and independence
- Facilitating chronic disease management
- Supporting individuals with significant functional impairment
- Reducing caregiving burden and improving quality of life
For this reissuance, PCORI especially encourages applications focused on improving the health care and health outcomes for older adults with multiple chronic conditions and those with sensory impairments such as loss of vision or hearing, as well as care models for individuals living with Alzheimer’s Disease and Related Dementias (ADRD). Applications of particular interest are those examining interventions that emphasize caregiver needs as well as those focusing on delivery models that integrate primary and specialty care as well as community-based services. PCORI further encourages applications focused on populations benefiting from a health equity approach, including those who are underserved, underrepresented or historically excluded.
Interested researchers should attend applicant webinar on September 13 and send a Letter of Intent by October 3 by 5 pm (ET). A total of $50 million in funding is available, with up to $12 million for each award.
CMS white paper assesses Innovation Center focus on health equity
Historically, Centers for Medicare & Medicaid Services (CMS) Innovation Center models were not designed explicitly to serve underserved populations, and most evaluations have not focused on health equity-related outcomes. In its 2021 strategy refresh, the Innovation Center prioritized health equity in all of its operations. To support the new goals, a retrospective analysis of model evaluations was conducted to determine the reach of Innovation Center models and assess the degree of and impact of health equity incorporation in model designs and evaluations. This analysis, “Assessing Equity to Drive Health Care Improvements: Learnings from the CMS Innovation Center,” identified means for evaluating health equity impacts and revealed gaps.
The review yielded three primary insights:
- The quality of the race/ethnicity variables in Medicare and Medicaid claims data presents a challenge for understanding whether models reach and enroll underserved individuals.
- Model designs have not always considered needs specific to underserved individuals.
- Model designs that do not prioritize the inclusion of underserved individuals may have small sample sizes for these populations that limits the ability to draw conclusions.
This study provides a foundation for assessing equity in prior health care models and for designing and promoting equitable quality improvement and evaluation.
Additional Reads
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- A review of the neurological imaging techniques in dementia diagnosis (read here)
- Deprescribing efforts failing dementia patients, study finds (read here)
- Dementia and Seizures: What’s the Relationship? (read here)
- LGBTQ+ caregivers of people with dementia face unique stresses that lead to poorer physical and mental health (read here)
- A fitness tracker for brain health: How a headband can identify early signs of Alzheimer’s disease in your sleep (read here)
- ‘Molecular road’ to Alzheimer’s leads to new treatment strategy (read here)
- Does microRNA-132 have therapeutic potential against Alzheimer’s disease? (read here)
- Intermittent Fasting Improves Alzheimer’s Pathology (read here)
- Melatonin and its Derivatives Enhance Long-Term Object Recognition Memory (read here)
- “Viral relicts” in the Genome Could Fuel Neurodegeneration (read here)
- Caution: Living Alone Puts People with Cognitive Decline at Risk (read here)
- Several vaccines associated with reduced risk of Alzheimer’s disease in adults 65 and older (read here)
- AI‐based assessments of speech and language impairments in dementia (read here)
- Long-Term Exposure to Air Pollution Increases Dementia Risk (read here)
- Restoring Helper Cell Function to Fight Alzheimer’s (read here)
- Price of elder care soars as demand increases, baby boomers age (read here)
- Disease severity and mortality in Alzheimer’s disease: an analysis using the U.S. National Alzheimer’s Coordinating Center Uniform Data Set (read here)
- Stanford Medicine-led research identifies gene ‘fingerprint’ for brain aging (read here)
- Opportunities For States To Promote Caregiver Integration For Hospitalized Patients (read here)
- Projected Savings to Canadian Provincial Budgets from Reduced Long-Term Care Home Utilization Due to a Disease-Modifying Alzheimer’s Treatment (read here)
- Does One Copy of the Christchurch ApoE Variant Slow Alzheimer’s? (read here)
- Study links changes in brain immune cells to Alzheimer’s (read here)
- Wanted: Fluid Biomarkers for CAA, ARIA (read here)
- Tau-PET: a window into the future of Alzheimer’s patients (read here)
- Stem Cell Therapy Rescues Symptoms of Alzheimer’s Disease (read here)
- Tiny Brains In a Dish Could Finally Uncover The Long-standing Mysteries of Psychedelics (read here)
- Alzheimer’s gene associated with increased fertility in Amazonian women (read here)
- Paying For Dementia Care That Improves Patient Outcomes, Supports Caregivers, And Saves Money (read here)
- Is ARIA an Inflammatory Reaction to Vascular Amyloid? (read here)
- Associations between air pollution and mental health service use in dementia: a retrospective cohort study (read here)
- Unraveling Alzheimer’s Catalysts as Weavers of Amyloid β Fibrils ~Molecular Mechanism of Accelerated Formation of Amyloid β Fibrils on Neuronal Cell Membranes (read here)
- Major US health systems expect to offer Alzheimer’s drug Leqembi in a few months (read here)
- Why consumer tests for risk of Alzheimer’s have potential downsides (read here)
- Researchers Propose a Data-driven Strategy to Stratify Risk of Progression from Mild Cognitive Impairment to Alzheimer’s disease (read here)
- Cohort LEADS Toward Better Understanding of Sporadic Early Onset AD (read here)
- The Healing Power of Art: Exploring its Therapeutic Benefits in Disease Treatment and Prevention (read here)
- Insulin-like hormones critical for brain plasticity (read here)
- Stress in childhood linked to physical and cognitive problems in older age, according to new study (read here)
- Increased Risk of Dementia Diagnosis, Benzodiazepine Exposure in Seniors with Anxiety (read here)
- Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution (read here)
- Former Sen. Max Baucus: Breakthrough Alzheimer’s drugs are out of reach for many in rural states like Montana (read here)
- The State of Artificial Intelligence and Machine Learning for Diagnosing, Differentiating and Predicting Prognosis in Dementia (read here)
- Diet Rich in Ultra-Processed Foods Can Accelerate Dementia Risk (read here)
- Novel vaccine key to reduce Alzheimer’s impact (read here)
- Minds & eyes: Study shows dementia more common in older adults with vision issues (read here)
- New policy research unit to improve dementia prevention, diagnosis and care (read here)
- Dementia care navigation: Building toward a common definition, key principles, and outcomes (read here)
- Estimating presymptomatic episodic memory impairment using simple hand movement tests: A cross‐sectional study of a large sample of older adults (read here)
- New Ultrasound Therapy Could Help Treat Alzheimer’s, Cancer (read here)
- TRIM11 protects against tauopathies and is down-regulated in Alzheimer’s disease (read here)
July, 2023 News
Senate HELP Committee reports out bipartisan pandemic prevention bill
On July 20, the Senate Health, Education, Labor, and Pensions (HELP) Committee, favorably reported out the bipartisan Pandemic and All-Hazards Preparedness and Response Act (PAHPA; S.2333, bill text with adopted amendments from Senator Hickenlooper and Senator Budd) on a 17-3 vote. PAHPA strengthens the nation’s biosecurity and biosafety, addresses the needs of at-risk populations, strengthens public health communications, coordinates research relating to long COVID, supports innovative technologies like wastewater surveillance, and reauthorizes the medical countermeasure priority review voucher program (see the legislation’s section-by-section details). Specifically, the Pandemics and All-hazards Preparedness and Response Act includes provisions to:
- Reauthorize core public health preparedness programs including the Public Health Emergency Preparedness cooperative agreements, the Hospital Preparedness Program, the Epidemiology Laboratory Capacity cooperative agreements, the Biomedical Advanced Research and Development Agency and the Strategic National Stockpile.
- Expand the representation of seniors and people with disabilities who advise the federal government on emergency preparedness.
- Require states to create crisis standards of care that prohibit discrimination of older adults and people with disabilities during disasters and emergencies.
- Promote better public health data-sharing during an outbreak.
- Establish a no-fault reporting system for laboratories to create a safety feedback loop.
- Support research and surge capacity during a pandemic.
- Support ongoing wastewater surveillance efforts.
- Examine the potential vulnerabilities to health security posed by artificial intelligence.
- Ensure that manufacturers communicate circumstances that may result in drug shortages and provide information to FDA in order to avoid potential shortages.
- Reauthorize the medical countermeasure priority review program.
Phase 3 confirmatory study shows donanemab significantly slows cognitive and functional decline early symptomatic Alzheimer’s disease
On July 17, Eli Lilly presented full results (see slides) from the Phase 3 TRAILBLAZER-ALZ 2 study (NCT04437511) showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease (either mild cognitive impairment or mild dementia). The data were shared at the 2023 Alzheimer’s Association International Conference (see the Alzheimer’s Association statement) and simultaneously published in the Journal of the American Medical Association (Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial). Lilly previously announced that donanemab met the primary and all cognitive and functional secondary endpoints in the Phase 3 study. Submission to the U.S. FDA for traditional approval was completed last quarter with regulatory action expected by the end of the year. Submissions to other global regulators are currently underway, and the majority will be completed by year end.
Participants in TRAILBLAZER-ALZ 2 were stratified by their level of tau, a predictive biomarker for disease progression, into either a low-medium tau group (sometimes referred to as intermediate tau) or a high tau group, which represented a later pathological stage of disease progression. All participants were then assessed over 18 months using scales that measure both cognition and function, including the integrated Alzheimer’s Disease Rating Scale (iADRS) and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). As previously reported, among participants with low-medium levels of tau (n=1182), donanemab treatment significantly slowed decline by 35% on iADRS and 36% on CDR-SB. Among all amyloid-positive early symptomatic AD study participants (n=1736), treatment with donanemab significantly slowed decline by 22% on iADRS and 29% on CDR-SB.
PCHETA reintroduced in Senate
Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) recently re-introduced the Palliative Care and Hospice Education and Training Act (PCHETA; S. 2243), bipartisan legislation to bolster the palliative care and hospice workforce and meet the growing need for care by investing in training, education, and research. Palliative and hospice care focus on relieving patients’ suffering from serious illnesses and working to improve their quality of life. Medical research shows that palliative and hospice care have been associated with enhanced quality of life for patients, reduced hospital expenditures and lengths of stay, and longer patient survival time. PCHETA would help ensure the necessary workforce to treat patients and improve the quality of life for millions of Americans facing serious illness by focusing on three key areas:
- Workforce Training – Supports the training of interdisciplinary health professionals, including physicians, nurses, social workers, physician assistants, chaplains, and others in palliative care; supports the training and retraining of faculty; and provides students with clinical training in appropriate sites of care.
- Education and Awareness – Shares research and information with patients, families, and health professionals about the benefits of palliative care and the services that are available to support patients with serious or life-threatening illnesses.
- Enhanced Research – Directs the Department of Health and Human Services (HHS) to use existing authorities and funds to expand palliative care research to advance clinical practice and improve care delivery for patients with a serious or life-threatening illness.
For additional information, read the PCHETA one-pager and the Palliative Care At-a-Glance factsheet.
RAISE Family Caregiving Advisory Council to start second term
The RAISE Family Caregiving Advisory Council — established by the Recognize, Assist, Include, Support, and Engage (RAISE) Family Caregivers Act — is charged with providing recommendations on effective models of family caregiving and support to family caregivers as well as improving coordination across federal government programs. On June 27, from 2:00 to 4:30 p.m. ET, the Administration for Community Living (ACL) will host a virtual joint meeting (public meeting access will begin at approximately 1:55 p.m. ET) to kick-off the new RAISE Family Caregiving Advisory Council and the Advisory Council to Support Grandparents Raising Grandchildren (SGRG). During the joint meeting, ACL will introduce and swear-in new council members for three-year terms. Additionally, federal leaders and partners will deliver presentations about the way forward for the work of the councils, and preview the next joint advisory council meeting (September 19). All information for the July 27 meeting, including an agenda, will be posted on the RAISE and SGRG webpages in advance of the meeting. Contact RAISE.mail@acl.hhs.gov with any questions.
FDA gives traditional approval to Leqembi, CMS offers broader coverage
On July 6, the U.S. Food and Drug Administration (FDA) converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. For details, read the full FDA statement and the full FDA-approved label, which contained a boxed warning. Please also read the full statement from Eisai and Biogen, which jointly developed Leqembi.
Immediately following FDA’s decision, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that it was broadening coverage for Leqembi. A CMS-facilitated registry is open for clinicians to access here. According to CMS
To receive Medicare coverage, people will need to: 1) be enrolled in Medicare, 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain, and 3) have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. Clinicians participating in the registry will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.
For additional information, read the full CMS statement along with the provider (download here) and consumer fact sheets (download here), and watch the short video demonstrating how health providers should enroll patients in the CMS registry.
The LEAD Coalition extends its gratitude to the FDA for its rigorous scientific examination of the evidence along with its careful consideration of stakeholder input, particularly regarding the necessity of addressing the high unmet need for treatments to slow the progression of Alzheimer’s disease. The LEAD Coalition commends CMS for listening and responding to the unified voice of the dementia advocacy community — including people facing Alzheimer’s disease, scientists and health care providers, LEAD Coalition member and allied organizations, bipartisan Members of Congress and state attorneys general, and others — by moving a great deal closer toward coverage-to-label over the past two years. The LEAD Coalition remains committed to working with CMS and other payers to lower and remove barriers to access for all FDA-approved treatments to prevent, slow, stop, or otherwise treat Alzheimer’s disease and other causes of dementia.
Treat and Reduce Obesity Act reintroduced
Senators Tom Carper (D-DE) and Bill Cassidy (R-LA) and Representatives Raul Ruiz (D-CA) and Brad Wenstrup (R-OH) have reintroduced the Treat and Reduce Obesity Act (TROA; bill text). According to the Centers for Disease Control and Prevention, diseases associated with obesity are the leading causes of preventable death in the U.S. The legislation would work to prevent these diseases through expanded coverage of new health care specialists and chronic weight management medications for Medicare beneficiaries. The bill also would work to mitigate the obesity epidemic by providing regular screenings.
Researchers publish first-ever county-level prevalence estimates for Alzheimer’s disease dementia
Rush University researchers have published the first-ever Alzheimer’s disease dementia prevalence estimates for each of the United States’ 3,142 counties. The study utilized cognitive data from the Chicago Health and Aging Project, a population-based study, and combined it with the National Center for Health Statistics 2020 bridged-race population estimates to determine the prevalence of Alzheimer’s disease in adults age 65 or older. The highest rates of prevalence were shown to occur in the East and Southeast US in states such as Maryland (12.9%), New York (12.7%), and Mississippi (12.5%). For counties with a population of 10,000 or more individuals age 65 or older, they estimate the highest Alzheimer’s prevalence rates were:
- Miami-Dade County, Fla. (16.6%)
Baltimore City, Md. (16.6%)
Bronx County, N.Y. (16.6%)
Prince George’s County, Md. (16.1%)
Hinds County, Miss. (15.5%)
Orleans Parish, La. (15.4%)
Dougherty County, Ga. (15.3%)
Orangeburg County, S.C. (15.2%)
Imperial County, Calif. (15.0%)
El Paso County, Texas (15.0%)
A combination of specific demographic characteristics may explain the higher prevalence in these counties, including older average age and higher percentages of Black and Hispanic residents. For example, among residents age 65 years and older of the Bronx County in New York, 14% were 85 and older (compared to a national average of 12% of people 65 and older), 30.1% were African Americans and 46.9% were Hispanic Americans (compared to national averages of 9.4% and 8.8%, respectively). The state- and county-specific estimates could help public health officials to understand the burden of disease (e.g., demand for caregiver counseling and institutional care) and develop strategies for identifying and caring for people with Alzheimer’s disease dementia. For additional details, see this interactive county-level map.
AARP’s GCBH issues recommendations for promoting brain health globally
AARP and the Global Council on Brain Health (GCBH) have released a report, “Building Better Brain Health for All People: GCBH Recommendations on Removing Barriers and Improving Opportunities Around the World,” which explores challenges to brain health faced by different communities around the world and offers recommendations to address such challenges. Within every country, public policies, political systems, economic conditions, social norms, and environmental factors influence health and wellness for better or worse. Discrimination based on age, race, ethnicity, gender and gender identity/roles, sexual orientation, national origin, caste, disabilities (visible as well as invisible), and genetic forms of neurological diseases contributes to poor physical and mental health in many societies. Barriers rooted in government policy, health care, institutional values, professional practice, and culture itself all may stand in the way of optimal brain health. To address these factors, the GCBH took a multifaceted approach, featuring nearly 40 recommendations, grounded in the latest scientific research and informed by the lived experience of individuals with cognitive loss. Innovations in policy, research, technology, community engagement, infrastructure, environmental design, and family supports are discussed in the report as parts of the answer.
Coalition launches action plans to improve nursing home quality
The national Moving Forward Nursing Home Quality Coalition recently released nine detailed action plans to improve the quality of life for residents and quality of work for staff in nursing homes. Each plan outlines specific steps to advance nursing home quality improvement:
- Creating care planning and measurement tools for residents’ goals, preferences & priorities
- Piloting best practices to strengthen nursing home resident councils
- Increasing CNA compensation through state quality incentive payment programs
- Developing a Certified Nursing Assistant (CNA) career pathway model using an established apprenticeship program framework to increase interest in the profession
- Creating a targeted recertification survey to improve overall state survey agency capacity
- Developing enhanced state surveyor trainings on person-centered care
- Increasing nursing home ownership data transparency
- Developing a health information technology guide to help nursing home operators navigate new regulations and digital capabilities
- Incentivizing converting traditional nursing homes with less privacy to smaller households with private rooms
Comprised of more than 120 individuals and organizations focused on nursing home reform, the Coalition launched in September 2022 to act on the National Academies of Sciences, Engineering, and Medicine report, The National Imperative to Improve Nursing Home Quality. The Coalition is funded by The John A. Hartford Foundation, and draws on leadership from LeadingAge, the Institute for Healthcare Improvement, other national organizations and advisors.
Additional Reads
- As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up (read here)
- Dementia becomes an emergency 1.4 million times a year (read here)
- Dementia Linked With Depression in Early and Middle Life (read here)
- Sleep Architecture, Obstructive Sleep Apnea, and Cognitive Function in Adults (read here)
- Oral Tau Inhibitor Continues to Show Promise in Alzheimer’s (read here)
- Mason research on supportive decision making could help people living with dementia (read here)
- Living in disadvantaged neighborhoods linked to higher dementia risk, study finds (read here)
- Detecting Alzheimer’s Disease: Older Adults’ Experiences with Cognitive Screening & Blood Biomarker Testing (read here)
- Intergenerational Trauma Among Elders (read here)
- Bodybuilding Supplement May Help Stave off Alzheimer’s (read here)
- These proteins could predict dementia risk decades before symptoms, new study suggests (read here)
- Lewy body disease can be detected before symptoms (read here)
- A New Way Of Diagnosing Alzheimer’s Disease Is On The Horizon (read here)
- Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial (read here)
- Promoting Healthy Aging: Public Health as a Leader for Reducing Dementia Risk (read here)
- New study shows anti-inflammatory drugs as a promising target for Alzheimer’s disease (read here)
- CRISPR/Gene Editing Technology Creates New Treatment Possibilities for Alzheimer’s Disease (read here)
- Lifestyle Enrichment in Later Life and Its Association With Dementia Risk (read here)
- Artificial intelligence tool that counts brain lesions in seconds (read here)
- A Novel Biosensor for Detecting Neurodegenerative Disease Proteins (read here)
- Biomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials (read here)
- Lecanemab to be Tested in Preclinical Alzheimer Disease (read here)
- Dementia Treatment: An Unmet Need (read here)
- The link between hearing loss and dementia (read here)
- Artificial Intelligence Is Everywhere You Look in Dementia Research (read here)
- This certification, developed with the Alzheimer’s Association, recognizes assisted living communities that use best practices for residents with dementia. (read here)
- Fast-spiking parvalbumin-positive interneurons in brain physiology and Alzheimer’s disease (read here)
- We finally have new Alzheimer’s drugs. How do we decide who gets them? (read here)
- A new era for Alzheimer’s treatment begins (read here)
- Taking good care of your teeth may be good for your brain, study suggests (read here)
- Fluctuating levels of cholesterol and triglycerides linked to increased risk of dementia (read here)
- Proteomics of brain, CSF, and plasma identifies molecular signatures for distinguishing sporadic and genetic Alzheimer’s disease (read here)
- Study suggests resistance training can prevent or delay Alzheimer’s disease (read here)
- Mortality and Discharge Location of Intensive Care Patients With Alzheimer Disease and Related Dementia (read here)
- Dementia is not the end of learning (read here)
- How a Swedish start-up reignited the search for an Alzheimer’s drug (read here)
- Repurposing Artificial Intelligence Tools for Disease Modeling: Case Study of Face Recognition Deficits in Neurodegenerative Diseases. (read here)
June, 2023 News
LEAD Coalition renews call for Congress to boost FY 2024 dementia funding
Healthy Brain Initiative releases new HBI Roadmap
On June 29, the fourth edition of the Healthy Brain Initiative (HBI) Road Map was released (see: full document and executive summary). “Healthy Brain Initiative: State and Local Road Map for Public Health, 2023-2027” provides public health officials nationwide with a set of strategies to promote brain health and improve the quality of life for people living with dementia and their caregivers. LEAD Coalition executive director Ian Kremer, along with representative of numerous LEAD Coalition member and allied organizations, served on the Leadership Committee to help develop this new edition of the HBI Road Map. The Alzheimer’s Association and the Centers for Disease Control and Prevention (CDC) jointly have led efforts to develop the evolving Healthy Brain Initiative Road Map Series for over 15 years.
- Strengthening partnerships and policies
- Measuring, evaluating, and utilizing data
- Building a diverse and skilled workforce
- Engaging and educating the public
Data and examples are included throughout to help state and local health departments achieve outcomes both individually and collectively. This Road Map advances equity by fully integrating brain health and caregiving into state and local public health practice and addressing social determinants of health that impact brain health across the life course. The Road Map provides public health practitioners with opportunities to reach diverse communities and reduce health disparities. For additional information, please attend the LEAD Coalition’s August 12 meeting, which will feature a guest presentation by the CDC and Alzheimer’s Association.
Roche’s tTau and Abeta42 Alzheimer’s assays receive FDA clearance
New report addresses healthy aging indicators
An analysis, “Indicators of Healthy Aging: A Guide to Explore Healthy Aging Data through Community Health Improvement,” conducted by the National Association of County and City Health Officials (NACCHO), found that most Community Health Improvement Plans (CHIPs) include priorities that, while not specifically addressing older adults, could be adapted for healthy aging programs. These priorities include chronic diseases, including heart disease, diabetes, stroke, and cancer, as well as substance use, depression, and other mental health conditions. To develop and strengthen age-friendly public health systems, a more comprehensive set of healthy aging indicators is needed to help health departments and community partners at the local, state, tribal, and territorial levels measure and identify population-level health disparities and inequities. Additionally, Community Health Improvement (CHI) partners need a robust, unified source of secondary data that aligns with healthy aging indicators to inform strategic and action planning.
This guide, developed by Trust for America’s Health and the National Association of County and City Health Officials (NACCHO) and with funding from The John A. Hartford Foundation, is designed to augment NACCHO’s Mobilizing for Action through Planning and Partnerships (MAPP) framework. MAPP is the most widely used CHI framework among governmental public health departments and, increasingly, community-based organizations, nonprofit hospital systems, and community health centers that lead or engage in CHI processes. This also serves as a resource for health departments seeking to attain Age-Friendly Public Health Systems (AFPHS) recognition.
Unanimous FDA advisory committee finds clinical benefit of lecanemab in treating Alzheimers disease
The Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) met on June 9 (FDA–2023–N–1114) to discuss supplemental biologics license application (sBLA) 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of early Alzheimer’s disease. This product was approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) for the treatment of Alzheimer’s disease. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The PCNS advisory committee discussed the confirmatory study, BAN2401–G000–301 (see: New England Journal of Medicine publication of Clarity AD study results), conducted to fulfill post-marketing requirement 4384–1 detailed in the January 6, 2023, approval letter. On the sole voting question, the PCNS advisory committee unanimously found that the Phase 3 Clarity AD study verified lecanemab’s clinical benefit.
For additional information, watch the recorded meeting webcast, review meeting background materials posted by the FDA, read the written public comments, and read the Eisai press statement. The PDUFA target action date for this sBLA is July 6.
LEAD Coalition urges CMS to adopt geriatrics quality measures
Over 240 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Centers for Medicare and Medicaid Services (CMS) expressing strong support for inclusion of the Geriatrics Hospital Measure and the Geriatrics Surgical Measure in the CMS Hospital Inpatient Quality Reporting (IQR) Program (proposed rule CMS-1785-P). Developed by the American College of Surgeons (ACS), the Institute for Healthcare Improvement (IHI), and the American College of Emergency Physicians (ACEP), these measures are designed to help build a better, safer, more age-friendly environment for geriatric hospital patients and will help patients and caregivers know where to get high-quality care that is in line with their values. These measures are a critical piece in optimizing care for older patients by using a holistic approach to create a quality program that better serves the needs of Medicare beneficiaries, especially those living with dementia. Read the full LEAD Coalition letter.
Expert panel calls for urgent policy changes to address inequitable access to Alzheimer’s drugs
An expert working group convened by the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and LuMind IDSC Foundation, has issued an advisory and consensus statement on criteria for access for adults with Down Syndrome (DS) to Alzheimer’s disease therapeutics (read the full report). The advisory follows a painstaking review of equity challenges faced by adults with DS with accessing the new class of anti-amyloid drug for mild cognitive impairment and early Alzheimer’s dementia. Adults with DS have an estimated lifetime risk of up to 90% for Alzheimer’s disease, which contributes to over 70% of their deaths. Adults with DS will face multiple years delayed access to these disease modifying treatments compared to other at-risk populations, because of exclusionary state prescribing authorization criteria (see table). Without urgency in altering these criteria, a generation of aging adults with DS potentially will be deprived of access to new treatments.
To shorten the time for access and to avoid delay in treatment, the working group recommends access through two actions: states and other payers should adopt the proposed DS-focused equivalency criteria as soon as possible, and Phase 4 clinical trials in adults with DS should be undertaken with similar urgency so that clinicians gain relevant information on the safety of this class of drugs for these atypical patients. The working group recommends a series of wording changes to reflect equivalencies in the prescribing criteria, offers substantiation for such changes, and calls upon relevant organizations to provide education to prescribers, and for professional associations to issue protocols for guiding prescribers in the use of this class of Alzheimer’s disease drugs.
Bipartisan legislation seeks to improve diversity in all NIH-funded trials
U.S. Senators Bob Menendez (D-N.J.) and Susan Collins (R-Maine), along with Representatives Robin Kelly (D-Ill.-02) and Brian Fitzpatrick (R-Pa.-01), recently introduced bipartisan, bicameral legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. The NIH Clinical Trial Diversity Act (S.1701/H.R.3503) builds upon the NIH’s current policies to enhance the inclusion of women, racially and ethnically diverse individuals and people of all ages in all NIH-funded trials. The NIH Clinical Trial Diversity Act would:
- Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan;
- Ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow ups, phone participation, weekend hours) to increase participation of underrepresented populations;
- Launch a public awareness campaign across federal agencies related to research participation opportunities.
President appoints Dr. Mandy Cohen as CDC Director
President Biden is appointing Dr. Mandy Cohen, an internal medicine physician, as Director of the Centers for Disease Control and Prevention (CDC). Under current law (which will change in 2025), the position does not require Senate confirmation. Dr. Cohen currently is Executive Vice President at Aledade and CEO of Aledade Care Solution, which helps independent primary care practices, health centers, and clinics deliver better care to their patients and thrive in value-based care. Previously, Dr. Cohen had served as Secretary of North Carolina’s Department of Health and Human Services. She also was Chief Operating Officer and Chief of Staff of the Centers for Medicare and Medicaid Services (CMS), and served as Acting-Director of the Center for Consumer Information and Insurance Oversight (CCIIO). Dr. Cohen was involved in many aspects of the Affordable Care Act policy development and implementation, including the expansion of coverage, insurance protections, and new provider payment models. A graduate of Cornell University, Dr. Cohen received her medical degree from Yale School of Medicine and a Master’s in Public Health from the Harvard School of Public Health. She trained in internal medicine at Massachusetts General Hospital. For analysis, click here.
LEAD Coalition joins wider health advocacy community in urging confirmation of NIH Director nominee
The LEAD Coalition joined 114 organizations in a letter to Senate leadership urging swift confirmation of President Biden’s nominee, Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH). Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Dr. Bertagnolli currently is Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director.
Issue brief proposes HCBS equity framework
In recent decades, long-term care has shifted from institutional settings to home and community-integrated settings. While access to home and community-based services (HCBS) has been increasing, systemic inequalities due to racism, sexism, ageism, classism, and other factors have led to large disparities in HCBS for diverse communities. Justice in Aging has published an issue brief, “An Equity Framework for Evaluating and Improving Medicaid Home and Community Based Services,” which evaluates ways the current organization of HCBS can contribute to inequities. The issue brief examines program design, provider availability, awareness of HCBS, implicit bias in services, and provision of HCBS. For each one of these domains, the issue brief provides case studies to help explain why the current policies lead to inequities. Additionally, the issue brief outline specific policies that should be reviewed in order to improve overall equity in HCBS programs.
Additional Reads
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- International Research Consortium Urges Scientists to Re-Think What Causes Alzheimer’s and Other Dementias (read here)
- Higher levels of lean muscle may protect against Alzheimer’s disease (read here)
- AI tool could speed up dementia diagnosis (read here)
- Menopausal hormone therapy and dementia: nationwide, nested case-control study (read here)
He Has Serious Dementia. Courts Are Still Waiting to Try Him for Murder. (read here)
Shorter Telomeres Point to Increased Alzheimer’s Risk (read here) - Understanding the value of secondary research data (read here)
- Changes in Human Microbiome Precede Alzheimer’s Cognitive Declines (read here)
- Blood condition linked to protection against Alzheimer’s (read here)
- Researchers show the importance of the liver-brain axis in Alzheimer’s disease (read here)
- Galectin-3 activates spinal microglia to induce inflammatory nociception in wild type but not in mice modelling Alzheimer’s disease (read here)
- Federal Data for Conducting Patient-centered Outcomes Research on Economic Outcomes (read here)
- A Closer Look at Hearing Loss, Dementia, and Stigma (read here)
- Abnormalities in neurodevelopment could lay the foundations for Alzheimer’s disease (read here)
- Ultra small molecule as a new target for Alzheimer’s disease? (read here)
- You’ll Soon Be Able to Get a Blood Test for Alzheimer’s (read here)
- VA researcher helping to change the future of Alzheimer’s Disease (read here)
- How Hospice Eligibility Criteria Can Adversely Affect Dementia Patients (read here)
- Altered gut bacteria may be early sign of Alzheimer’s disease (read here)
- Fluorogenic probe to detect enzyme linked to early stage of Alzheimer’s (read here)
- Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force (read here)
- AI helps show how the brain’s fluids flow (read here)
- Significant correlation found between vitreous human biomarkers and Alzheimer’s disease (read here)
- Brain waves may predict cognitive impairment in Parkinson’s disease (read here)
- Excessive alcohol consumption may accelerate Alzheimer’s disease progression (read here)
- UC Irvine neuroscientists develop ‘meta-cell’ to move Alzheimer’s fight forward (read here)
- Confronting aging: How LGBTQ+ seniors can tackle their special caregiving challenges (read here)
- Not covering emerging Alzheimer’s drugs could cost Medicare billions: study (read here)
- Dysesthesia and Depression in Undiagnosed Alzheimer’s Disease (read here)
- ArhGAP11A mediates amyloid-β generation and neuropathology in an Alzheimer’s disease-like mouse model (read here)
- Drawing, making music and writing poetry can support healing and bring more humanity to health care in US hospitals (read here)
- Supreme Court clears way for family of Medicaid recipient to sue state-owned nursing home (read here)
- Genetic protection from early-onset familial Alzheimer’s disease (read here)
- Researchers to Explore Potential of New Treatment Against Vascular Dementia (read here)
- Revealing How Blood Triggers Brain Disease (read here)
- Scientists Achieve Groundbreaking First by Applying Artificial Intelligence for Early Risk Forecasting of Alzheimer’s Disease (read here)
- A chance observation finds potential hearing biomarker for Alzheimer’s disease (read here)
- Improvement of retinal function in Alzheimer disease-associated retinopathy by dietary lysophosphatidylcholine-EPA/DHA (read here)
- Dementia Care Is Widespread In US Nursing Homes; Facilities With The Most Dementia Patients May Offer Better Care (read here)
- Improving the health and well-being of sexual and gender minority older adults (read here)
- The role of peripheral inflammatory insults in Alzheimer’s disease: a review and research roadmap (read here)
- Poorly insulated nerve cells promote Alzheimer’s disease in old age (read here)
- Alzheimer’s Disease Plasma Biomarker and Pathogenesis Contribute to Postoperative Delirium-like Behavior in Rodents (read here)
- Unweaving the microscopic threads of Alzheimer’s tapestry: single-cell dissection of vascular changes across six brain regions (read here)
- Being socially active in mid-late life linked to 30-50% lower dementia risk (read here)
- A Novel Blood Serum Assay to Diagnose Neurodegenerative Diseases (read here)
- Expanding Access to Alzheimer’s Care & Treatment (watch here)
May, 2023 News
President nominates Dr. Monica Bertagnolli as NIH Director
President Biden is nominating Dr. Monica Bertagnolli to serve as Director of the National Institutes of Health (NIH). Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Dr. Bertagnolli currently is Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director. Previously, she served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. Dr. Bertagnolli is a member of the National Academy of Medicine, a past president and chair of the board of directors of the American Society of Clinical Oncology, and has served on the board of directors of the American Cancer Society and the Prevent Cancer Foundation. For analysis, click here.
FDA approves first treatment for agitation symptoms associated with dementia due to Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.
According to the FDA:
The recommended starting dosage for the treatment of agitation associated with dementia due to Alzheimer’s disease is 0.5 mg taken once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily. The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.
The most common side effects among patients with agitation associated with dementia due to Alzheimer’s disease include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (both somnolence and insomnia). Rexulti will retain the Boxed Warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The sNDA submission, from sponsors Otsuka and Lundbeck, was based on data generated from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with agitation associated with dementia due to Alzheimer’s disease. See the sponsors’ full press release here. Please read Full Prescribing Information, including Boxed Warning, and Medication Guide.
CMS updates nursing home visitation guidance for COVID-19
CMS releases 2023 SSI and spousal impoverishment standards
NIA launches updated AD/ADRD Research Implementation Milestones database
NIA has released an enhanced database for tracking of Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) Research Implementation Milestones. These milestones represent a research framework detailing specific steps and success criteria towards achieving the goal of the National Plan to Address Alzheimer’s Disease. Spanning basic, translational, clinical, and health services research, the 204 current milestones were developed based on recommendations from over 350 leading academic and industry experts, innovators and public advocates participating at strategic research planning summits. Users can browse the milestones by Research Areas and further refine by more targeted Research Implementation Areas. For each milestone, users will find success criteria and the projected timeline, along with updated information on progress and achievements, including funding initiatives, research programs and resources, and highlights.
NAPA advisory council examines pathways to new clinical treatments and comprehensive dementia care
New report addresses nursing home oversight
Phase 3 study top line results show donanemab significantly slows cognitive and functional decline
For additional information, see this AlzForum backgrounder on donanemab development, along with news coverage here and here.
Bipartisan group of 26 state attorneys general call on Medicare to cover new Alzheimer’s treatments
Led by Attorneys General Gentner Drummond (R-OK) and Keith Ellison (D-MN), a bipartisan group representing nearly half the states and territories have written to U.S. Health & Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging that “CMS provide full and unrestricted Medicare coverage for FDA-approved Alzheimer’s treatments consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries.” (Read the full letter.) The letter from these attorneys general comes amid mounting bipartisan efforts in the U.S. House and Senate to press CMS to reconsider its national coverage determination (NCD) for FDA-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N).
Additional Reads
- Understanding cognitive decline among elderly with Dementia using the “Heart-to-Brain Connection” (read here)
- Research reveals clues to why immune cells seem to cause brain damage (read here)
- Agitation in Alzheimer Dementia: Progress for an Age-Old Problem (read here)
- Human microglia show unique transcriptional changes in Alzheimer’s disease (read here)
- Does “Good” Cholesterol Increase Your Risk of Alzheimer’s? (read here)
- New information on the development of Alzheimer’s disease – Study reveals a possible cause of inflammation (read here)
- New UCI-led research shows people who live to be 90+ with superior thinking skills are resilient to Alzheimer’s pathology in their brains (read here)
- A lifetime of racism makes Alzheimer’s more prevalent in Black Americans (read here)
- UMD Study Finds Brain Connectivity, Memory Improves in Older Adults After Walking (read here)
- Exercise seems to protect against major brain hemorrhage (read here)
- Recurrent Brain Trauma May Increase Alzheimer’s Risk (read here)
- Association of BCG Vaccine Treatment With Death and Dementia in Patients With Non–Muscle-Invasive Bladder Cancer (read here)
- Time for Dementia: Quantitative evaluation of a dementia education programme for healthcare students (read here)
- Social participation and risk of developing dementia (read here)
- Study: Blood Vessel Damage Could Be an Alzheimer’s Driver (read here)
- 40 Hz vibrations reduce Alzheimer’s pathology, symptoms in mouse models (read here)
- Towards a future where Alzheimer’s disease pathology is stopped before the onset of dementia (read here)
- Study of mouse neurons uncovers novel therapeutic role of removing a genetic variant in the treatment of Alzheimer’s disease (read here)
- Equity across the life course matters for brain health (read here)
- Hi-Res Spatial Proteomics Uncovers Aspects of Alzheimer’s Disease Pathology (read here)
- Dementia study shows how toxic proteins spread (read here)
- Effects of physical exercise on physical function in older adults in residential care: a systematic review and network meta-analysis of randomised controlled trials (read here)
- Inhaling menthol improves cognitive function in Alzheimer’s disease (read here)
- The Mother Who Changed: A Story of Dementia (read here)
- NIH researchers identify large genetic changes that contribute to dementia risk (read here)
- A special omega-3 fatty acid lipid will change how we look at the developing and ageing brain, Duke-NUS researchers find (read here)
- Rochelle Walensky exits as CDC chief (read here)
- Association between chronic pain and risk of incident dementia: findings from a prospective cohort (read here)
- Passing the sniff test: Can we train our brain to boost smell and memory? (read here)
- Regular internet use may be linked to lower dementia risk in older adults, study says (read here)
- Deep sleep may mitigate Alzheimer’s memory loss, Berkeley research shows (read here)
- Dementia and self-harm: why it’s crucial to support patients in first year after diagnosis (read here)
- Prioritising dementia at the G7 (read here)
- Air Pollution May Increase Risk of Dementia, Complicated by Genetics (read here)
- Stress increases Alzheimer’s risk in female mice but not males (read here)
- Medicare’s ‘Coverage With Evidence Development’: A Barrier To Patient Access And Innovation (read here)
- Upregulation of extracellular proteins in a mouse model of Alzheimer’s disease (read here)
- Sleep deprivation exacerbates microglial reactivity and Aβ deposition in a TREM2-dependent manner in mice (read here)
- The structural and social determinants of Alzheimer’s disease related dementias (read here)
April, 2023 News
FDA advisory committee concludes that brexpiprazole for Alzheimer’s dementia agitation has a positive benefit-risk profile
On April 14, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee held a joint meeting to discuss supplemental new drug application (sNDA) 205422 s009, efficacy supplement for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceuticals and Lundbeck, for the proposed treatment of agitation associated with Alzheimer’s dementia (AAD). The joint advisory committee voted 9-1 that “the Applicant provided sufficient data to allow identification of a population in whom the benefits of treating agitation associated with Alzheimer’s dementia with brexpiprazole outweigh its risks” (view meeting materials and the archived meeting webcast). FDA has assigned the sNDA priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10.
Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (reported in approximately 45 percent of patients with Alzheimer’s dementia) and has a large impact on quality of life for the people living with AAD, family members, and caregivers. Agitation covers a large group of behaviors, and it is an excessive manifestation of “normal” human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting. Brexpiprazole, an antipsychotic medication approved in 2015 by the FDA as adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood. The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 (NCT01862640) demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213 (NCT03548584), treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
NIH seeks proposals for real-world data platform to advance dementia research
The National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) have issued a request for applications to develop the Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (RWDP). The NIA will fund a 6-year, up to US$300 million project to develop the RWDP, which will represent 70–90% of the US population (including up to 80% of people living with dementia). The RWDP will help researchers access and analyze health data in a secure cloud computing environment, and recruit from a more diverse pool of individuals. The RWDP also will support collaboration among health care and community health providers to develop and facilitate innovative methods for scalable digital, decentralized, pragmatic, and clinical trials. For additional perspective, read the NIA blog and click here.
Lecanemab OLE shows benefits even after treatment discontinuation
Recently published research has demonstrated that Alzheimer’s patients who take LEQEMBI™ (lecanemab-irmb) retain treatment benefits even after discontinuing the medication. The open label extension (OLE) study included 350 patients with mild to moderate Alzheimer’s disease who had taken LEQEMBI™ for a minimum of six months. The patients were divided into two groups; one group continued taking the drug, and the other group stopped. After six months, the discontinuation group showed no significant decline in cognitive function compared to the continuation group. Further research is needed to confirm these findings and to determine the optimal duration of treatment.
NAPA Dementia Nomenclature Initiative webpage launched
CMS issues 2024 Medicare Advantage and Part D Final Rule
CMS Medicare-Medicaid Coordination Office submits report to Congress
President issues executive order on caregiving
Non-drug Alzheimer’s interventions are effective and cost-effective
While new drugs to treat Alzheimer’s disease tend to receive the most public attention, many well-researched ways to care for people with dementia don’t involve medication. A new study by Brown University researchers compared the cost-effectiveness of four non-drug interventions to the usual care received by people with dementia and found that the care interventions resulted in a better quality of life and saved money. The study’s computer simulation model showed that the care interventions saved between $2,800 and $13,000 in societal costs, depending on the type of intervention, and all reduced nursing home admissions and improved quality of life compared to usual care. In addition to finding that the interventions were cost-effective from a societal perspective, the researchers found the interventions involved little to no additional cost for health care payers. Based on the study findings, the authors concluded that health insurance policies should find ways to incentivize providers and health systems to implement nonpharmacological interventions.
CVS Health to launch home-based care program for older adults
CVS Health has announced plans to improve home-based care for older adults who have been discharged from an acute care setting. The new post-acute care transition program will assign a caregiver to participants’ homes and provide them other necessary resources, such as reconciling medications with their primary care provider, ensuring that the home is age-friendly, offering home visits and helping arranging food and transportation services. For additional details, click here.
FasterCures report develops tool for more equitable clinical trials
Important safeguards have been implemented to protect research participants such as the National Research Act and the Belmont Report, but there remains a need for equitable participation and benefit for diverse populations in clinical research. A new FasterCures report, Mapping the Journey: Building a Mutual Understanding for Health Equity in Clinical Research, provides a tool for stakeholders involved in clinical research to establish a common language and basis for exchange and understand the differences among different types of trial sites. The report also details practical recommendations for achieving health equity at different types of trial sites and a visual illustration of how a patient might experience a typical clinical trial. FasterCures’ aim with this tool and its ongoing work to achieve health equity is to promote a more accessible, equitable research enterprise and drive meaningful multi-stakeholder engagement.
Additional Reads
- First ‘gene silencing’ drug for Alzheimer’s disease shows promise (read here)
- Demographic diversity of genetic databases used in Alzheimer’s disease research (read here)
- In Medicare Drug Price Negotiations, Avoid Metrics Steeped In Stigma (read here)
- Common Infections Linked to Poorer Cognitive Performance in Middle-Aged and Older Adults (read here)
- Depression and anxiety in people with cognitive impairment and dementia during the COVID-19 pandemic: Analysis of the English Longitudinal Study of Ageing (read here)
- Dementia-Related Medication Disparities Persist for Racial, Ethnic Minority Patients (read here)
- How Some Common Drugs Can Increase the Risk of Dementia (read here)
- The associations of socioeconomic status with incident dementia and Alzheimer’s disease are modified by leucocyte telomere length: a population-based cohort study (read here)
- How Donanemab Compares With Aducanumab in Amyloid Clearance (read here)
- Sleeping pill reduces levels of Alzheimer’s proteins (read here)
- Online tool found to be effective at assessing dementia risk (read here)
- Genetic testing for Alzheimer’s is on the rise. But what happens when the results are dire? (read here)
- The Home Care Workforce Has Not Kept Pace With Growth In Home And Community-Based Services (read here)
- The Office of New Drugs’ Efforts to Expand Regulatory Science Research (read here)
- New project to measure Alzheimer’s and Parkinson’s via the ear (read here)
- Astrocyte Dysfunction Causes Cognitive Decline (read here)
- Blood Tests May Help Physicians in Low-Resource Environments Diagnose Alzheimer Disease (read here)
- Blood-based biomarkers for Alzheimer’s disease could greatly simplify diagnosis and reduce costs (read here)
- What Happens After Amyloid Plaque Removal? Who Benefits Most? (read here)
- What Does Plaque Clearance Mean for the Long Haul? (read here)
- A new peptide may hold potential as an Alzheimer’s treatment (read here)
- A PREP inhibitor may help stop the progression of frontotemporal dementia (read here)
- AI can spot early signs of Alzheimer’s in speech patterns, study shows (read here)
- Screening for Delirium: What Clinicians Should Know (read here)
- People Living With Early Alzheimer’s Need President Biden’s Help (read here)
- Activation of hypothalamic-enhanced adult-born neurons restores cognitive and affective function in Alzheimer’s disease (read here)
- Half of carers for people with dementia struggling to make ends meet, study finds (read here)
- Scientists Enhance New Neurons to Restore Memory, Elevate Mood in Alzheimer’s Disease Research Model (read here)
- Air pollution may increase risk for dementia (read here)
- Phototherapy improves cognitive function in dementia: A systematic review and meta-analysis (read here)
- Conquering Alzheimer’s: a look at the therapies of the future (read here)
- Understanding factors influencing residential respite service use by carers of people living with dementia using Andersen’s behavioural model of health services use: A qualitative study (read here)
- Early menopause ‘may make women more likely to develop dementia’ (read here)
- How Can We Support Religious and Spiritual Practices of Older Adults With Mild Cognitive Impairment and #Dementia? (read here)
March, 2023 News
Breaking News: ADRD Therapeutics Work Group publishes Appropriate Use Recommendations for LEQEMBI™
On March 27, the Alzheimer’s Disease and Related Disorders Therapeutics Work Group (ADRD TWG) published its Appropriate Use Recommendations (AUR) for LEQEMBI™ (lecanemab-irmb). The abstract states:
Lecanemab (Leqembi®) is approved in the United States for the treatment of Alzheimer’s disease (AD) to be initiated in early AD (mild cognitive impairment [MCI] due to AD or mild AD dementia) with confirmed brain amyloid pathology. Appropriate Use Recommendations (AURs) are intended to help guide the introduction of new therapies into real-world clinical practice. Community dwelling patients with AD differ from those participating in clinical trials. Administration of lecanemab at clinical trial sites by individuals experienced with monoclonal antibody therapy also differs from the community clinic-based administration of lecanemab. These AURs use clinical trial data as well as research and care information regarding AD to help clinicians administer lecanemab with optimal safety and opportunity for effectiveness. Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Monitoring guidelines for these events are detailed in this AUR. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal. Microhemorrhages and rare macrohemorrhages may occur in patients receiving lecanemab. Anticoagulation increases the risk of hemorrhage, and the AUR recommends that patients requiring anticoagulants not receive lecanemab until more data regarding this interaction are available. Patients who are apolipoprotein E ε4 (APOE4) gene carriers, especially APOE4 homozygotes, are at higher risk for ARIA, and the AUR recommends APOE genotyping to better inform risk discussions with patients who are lecanemab candidates. Clinician and institutional preparedness are mandatory for use of lecanemab, and protocols for management of serious events should be developed and implemented. Communication between clinicians and therapy candidates or those on therapy is a key element of good clinical practice for the use of lecanemab. Patients and their care partners must understand the potential benefits, the potential harms, and the monitoring requirements for treatment with this agent. Culture-specific communication and building of trust between clinicians and patients are the foundation for successful use of lecanemab.
Administration releases FY 2024 budget proposal
Most administrations’ annual budget proposals are considered effectively “dead on arrival” by Congress, since Congress exerts control through the House and Senate Appropriations Committees. Especially in periods of divided government, this maxim tends to hold true. So while the FY 2024 Budget Proposal and the departmental Budget in Brief documents are important markers of what the Administration hopes its allies in Congress will support, they are unlikely to prove meaningful predictors of the funding levels that will be signed into law at the end of the FY 2024 congressional appropriations process.
Nonetheless, it is disappointing and troubling that the documents released on March 9 and March 13 fall far short of meeting urgent needs of the dementia community. For example, the proposal would increase overall NIH funding by only $920 million (far below the average annual increases in recent years) and shockingly would provide a paltry $16 million increase to the National Institute of Neurological Disorders and Stroke (NINDS) and provide no increase at all to the National Institute on Aging (NIA) — the two NIH institutes that are central to federal research on Alzheimer’s, FTD, LBD, VCID, and mix forms of dementia. Dementia research essentially would be flat-funded and, in fact, eroded by the effects of medical research inflation. This flies in the face of NIH’s own congressionally mandated, rigorous assessment of need articulated in the FY 2024 Professional Judgment Budget for Alzheimer’s Disease and Related Dementias. And while there are some laudable proposed increases in social safety net programs such as those at the Administration for Community Living, it is concerning that the Administration has proposed flat-funding for the Alzheimer’s Disease Program, Prevention of Elder Abuse and Neglect, and the Traumatic Brain Injury Program. For additional details, see the National Council On Aging (NCOA) table summarizing the Administration’s proposed 2024 funding for aging services programs.
LEAD Coalition member and allied organizations should remain optimistic in working with Congress and the Administration to take this starting point and refine it in the coming months to produce actual funding levels that better meet the urgent needs of the dementia community. Together, this stakeholder community can and must accelerate equity-centered and person-centered progress in risk reduction, detection and diagnosis, support to protect and promote quality of life for people with dementia and their care partners, and the pharmacologic and non-pharmacologic science to prevent, slow, stop and eventually end all forms of dementia.
Senators press HHS Secretary on CMS non-coverage of new Alzheimer’s treatments
CDC report examines racial and ethnic differences in subjective cognitive decline
VHA will provide veterans with broad coverage for LEQEMBI™
In a welcome break from the policy adopted by CMS, the U.S. Veterans’ Health Administration (VHA) is providing coverage for LEQEMBI™ (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease (AD). VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI™ to veterans who fit the VHA’s criteria and the U.S. Food and Drug Administration’s (FDA) current label. As Time Magazine reported, “The VA added Leqembi, which received accelerated approval from the Food and Drug Administration in January, to its list of nonformulary drugs. Patients who want to take the drug would have to request it and receive prior approval and meet stringent inclusion criteria, according to the VA website.”
LEQEMBI™: FDA priority review granted, July 6 PDUFA date set
The U.S. Food and Drug Administration (FDA) has accepted Eisai‘s supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI™ to a traditional approval. The LEQEMBI™ application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application, but has not publicly announced the date of the meeting. The sBLA is based on the findings from Eisai’s recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI™ met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
LEQEMBI™ was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI™ reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI™‘s clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. For additional details, see the full Eisai statement.
Roche and Lilly collaborating for early diagnosis of Alzheimer’s disease
Roche recently announced (see Reuters coverage) a new collaboration with Eli Lilly to support development of Roche’s Elecsys Amyloid Plasma Panel (EAPP). The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease. In July, Roche announced that the U.S. Food and Drug Administration granted the EAPP Breakthrough Device Designation. The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau181 occur in early stages of Alzheimer’s, while the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline. A two-year clinical trial is expected to involve several hundred study participants with early signs of dementia, and trial data may be available for an FDA regulatory filing as soon as 2025.
In December 2022, Roche also received FDA 510(k) clearance for its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays, which identify Alzheimer’s pathology in its early symptomatic stage.
Alzheimer’s Association publishes annual Facts and Figures report and special report on clinical conversations
On March 15, the Alzheimer’s Association released its 2023 Alzheimer’s Disease Facts and Figures report, providing an in-depth look at the latest national statistics on Alzheimer’s incidence, prevalence, mortality, costs of care, and impact on caregivers. The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression, and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available. For additional background, see the Alzheimer’s Association press release.
Dementia risk reduction infographic culturally tailored for AIAN communities
The International Association for Indigenous Aging (IA²) has adapted The Lancet Risk Factors for Dementia infographic and created a version, “Help Reduce Your Risks of Dementia,” culturally tailored toward American Indian and Alaska Native (AIAN) communities. The process of creating this infographic included talking circles with tribal community members, Dementia Friends & Champions, the University of Nevada, Reno Dementia Engagement, Education and Research (DEER) Program, IA²’s Brain Health Leadership team, and internal IA² staff members. This infographic is intended to be used within the Dementia Friends for American Indian and Alaska Native Information Session workbook.
NIH names new director for Tribal Health Research Office
Earlier this month, Lawrence Tabak, DDS, PhD, in performing the duties of the NIH director, announced that Karina Walters, PhD, MSW, will serve as the next director of the NIH Tribal Health Research Office (THRO). An enrolled member of the Choctaw Nation of Oklahoma, “Dr. Walters’ wealth of experience and deep commitment to engaging tribal leadership in health research efforts makes her ideally suited for the position,” Tabak said. “Her commitment to community-based participatory research is evident in her demonstrated ability to sustain collaborations with diverse Native communities and conduct successful randomized clinical trials in tribal communities,” he added. Walters succeeds David Wilson, PhD, who is on detail to the White House Council on Native American Affairs, and she will begin her new role as the THRO Director on April 24. For more information about Dr. Walters, click here.
NAC releases guide for patient advocacy groups to better support diverse family caregivers
The National Alliance for Caregiving (NAC) has released a new publication, Supporting Diverse Family Caregivers: A Guide for Patient Advocacy Groups, developed through research with professional patient advocacy group representatives and diverse family caregivers. The report addresses the impact of culture and identity on the way that family caregivers provide care, and introduces ways in which patient advocacy groups can support their caregiving experience through culturally responsive resources and supports. The number of diverse family caregivers in the United States is growing yearly, and their aggregate number will soon surpass non-Hispanic white, non-LGBTQ+ caregivers. According to Caregiving in the U.S. 2020, of the 53 million family caregivers in the United States, 17% identify as Hispanic/Latino, 14% identify as African American, 8% identify as LGBTQ+, and 5% identify as Asian American or Pacific Islander. The Centers for Disease Control and Prevention identifies one in every four American Indian or Alaska Native adults as family caregivers.
Additional Reads
- Alzheimer’s: New Study Supports Amyloid Hypothesis But Suggests Alternative Treatment (read here)
- Machine learning models rank predictive risks for Alzheimer’s disease (read here)
- In the whitewashed world of Alzheimer’s research, one scientist is on a quest to understand the diversity of brains (read here)
- Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds (read here)
- Getting to the root of Alzheimer’s disease (read here)
- Researchers propose a novel biomarker for early diagnosis of Alzheimer’s disease (read here)
- Individualized brain fingerprints can help to uncover early signs of Alzheimer’s disease (read here)
- Your Speech May Reveal Early Signs of Alzheimer’s (read here)
- Comparative Effectiveness and Safety of Oral Anticoagulants by Dementia Status in Older Patients With Atrial Fibrillation (read here)
- Food Insecurity and Cognitive Trajectories in Community-Dwelling Medicare Beneficiaries 65 Years and Older (read here)
- Gene therapy approach to boost ‘cold shock protein’ in the brain without cooling protects mice against neurodegenerative disease (read here)
- Why Alzheimer’s and Dementia Cause Mood Swings, and What to Do About Them (read here)
- Helping Older Adults Manage Alzheimer’s and Other Dementias (watch here)
- Are Hospitals Ready for Alzheimer’s Treatment Approval? (read here)
- Researchers identify new genes that modulate the toxicity of the protein β-amyloid, responsible for causing Alzheimer’s disease (read here)
- New Insights into Atypical Alzheimer’s Disease: From Clinical Phenotype to Biomarkers (read here)
- Blood Pressure Control May Help Mitigate Dementia Risk From Hypertension (read here)
- Promise of exosomal proteins as biomarkers in Alzheimer’s disease (watch here)
- Readmission Rates and Episode Costs for Alzheimer Disease (read here)
- Webinar: Alzheimer’s Treatment and Access (watch here)
- Masking a Splicing Site Compensates for TDP-43 Dysfunction (read here)
- Dementia, incontinence and the loss of dignity in acute hospitals (read here)
- Risk of death for people with dementia increases after a hurricane exposure (read here)
- Diabetes and Toothlessness Together Worsen Cognitive Decline (read here)
- Solving the Alzheimer’s Disease Puzzle: One Piece at a Time (read here)
- Lifetime discrimination linked to 40% higher risk of dementia, study finds (read here)
- Education and Dementia Incidence by Ethnicity and Nativity in Older Asian American Individuals (read here)
- Could Calming Overactive Ryanodine Receptor Restore Autophagy? (read here)
- Alzheimer’s Gene MS4A4A Governs the State of Microglia (read here)
- New Research Finds Antibody Detects Alzheimer’s Signals at Earliest Stages (read here)
- Do you already have Alzheimer’s? That’s what scientists at KU are asking young people (read here)
- Early diagnosis of Alzheimer’s disease (read here)
- Trouble falling asleep at bedtime or in the middle of the night? It could impact your risk for developing dementia (read here)
- No Country for Alzheimer’s Patients (read here)
- Those Declining Dementia Rates? It’s Not the Plaques and Tangles (read here)
- Black People Less Likely to Receive Dementia-Related Medications (read here)
- The Alzheimer’s Crisis in Indian Country (read here)
- Detecting mild cognitive impairment and dementia in older adults using naturalistic driving data and interaction-based classification from influence score (read here)
- Prevalence, Timing, and Network Localization of Emergent Visual Creativity in Frontotemporal Dementia (read here)
- Researchers identify three intestinal bacteria found in dementia with Lewy bodies (read here)
- Degrading modified proteins could treat Alzheimer’s, other ‘undruggable’ diseases (read here)
- Alzheimer’s and falls can be predicted using radar (read here)
- New Insights: Eye Damage in Alzheimer’s Disease Patients (read here)
- Why evenings can be harder on people with dementia—and how to cope (read here)
- Alzheimer’s Study Links Cholesterol And Toxic Protein Clusters (read here)
- Osteopontin may play key role in Alzheimer’s disease (read here)
- Distressing dreams in childhood and risk of cognitive impairment or Parkinson’s disease in adulthood: a national birth cohort study (read here)
- Vitamin D supplementation and incident dementia: Effects of sex, APOE, and baseline cognitive status (read here)
- Lilly Provides Update on A4 Study of Solanezumab for Preclinical Alzheimer’s Disease (read here)
- NIA statement on study results suggesting solanezumab does not reduce cognitive decline in people at risk for developing Alzheimer’s (read here)
- How Does Hospice Care Work? (read here)
- Study identifies four distinct pain trajectories in nursing home residents (read here)
- New AARP Report Finds Family Caregivers Provide $600 Billion in Unpaid Care Across the U.S. (read here)
- Senior care is crushingly expensive. Boomers aren’t ready. (read here)
- New report finds artificial intelligence fuels ageism in aged care (read here)
- DNA Treatment Could Delay Paralysis That Strikes Nearly All Patients with ALS (read here)
February, 2023 News
Breaking News: Director of FDA Office of Neuroscience announces retirement
Billy Dunn, M.D. is retiring from the U.S. Food and Drug Administration (FDA), where he has led the Office of Neuroscience (ON) in the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND). According to reporting in BioPharma Dive, Teresa Buracchio, M.D., an FDA veteran and currently the acting deputy director of the Office of Neuroscience, will take Dunn’s place on an acting basis.” The Office of Neuroscience consists of five review divisions: The Division of Neurology I, the Division of Neurology II, the Division of Psychiatry, the Division of Anesthesiology, Addiction Medicine, Pain Medicine, and the Division of Pharm/Tox for Neuroscience (DPT-N). The Immediate office oversees the development, review, and regulation of applications as well as issues related to toxicology for drug and biologic products reviewed in these divisions.
Dr. Dunn has served at FDA for over 17 years. Prior to joining FDA, Dr. Dunn served as a clinician and clinical researcher at the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). Dr. Dunn has served with distinction as a thoughtful leader and innovator, a determined regulator, and a powerful voice for addressing the high unmet needs of often marginalized people facing debilitating and life-threatening health conditions. The LEAD Coalition is deeply grateful for Dr. Dunn’s vision, leadership, and abiding commitment to improving quality of life for all who experience neurological disorders.
Check back here for updates on this breaking news.
FDA expects to complete reviews of brexpiprazole for Alzheimer’s dementia agitation by May 10
The U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (reported in approximately 45 percent of patients with Alzheimer’s dementia) and has a large impact on quality of life for the people living with AAD, family members, and caregivers. Agitation covers a large group of behaviors, and it is an excessive manifestation of “normal” human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting. Brexpiprazole (Rexulti), an antipsychotic medication approved in 2015 by the FDA as adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood.
FDA has assigned the sNDA priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10. The FDA also anticipates holding a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application, but a meeting date has not been set. According to brexpiprazole’s sponsors, Otsuka Pharmaceuticals and Lundbeck, the sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 (NCT01862640) demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213 (NCT03548584), treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
CMS rejects request to reconsider its denial of coverage for FDA-approved Alzheimer’s disease treatments
On February 22, the Centers for Medicare & Medicaid Services (CMS) rejected (see: full CMS statement) a formal request to reconsider its national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N). As noted in the subsequent Alzheimer’s Association statement, CMS covers all FDA-approved drugs except for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. The American Academy of Neurology (AAN) also had formally requested (see AAN letter) that CMS initiate an expedited NCD reconsideration focused on lecanemab (LEQEMBI™) and based on the phase III data from the CLARITY AD trial published in the New England Journal of Medicine, which showed clinical meaningful benefits including slowing of cognitive dysfunction and a decrease in the decline of activities of daily living. AAN wrote, in part, “Throughout the National Coverage Analysis (NCA) and NCD processes, the AAN repeatedly raised concerns regarding the potential unintended consequences of applying this NCD to the entire class of mAbs for the treatment of Alzheimer’s disease. The AAN is concerned that absent a reconsideration of the NCD, patients who could benefit from lecanemab will be denied access, due to restrictions found in the NCD, leading to irreversible disease progression that could have been slowed with treatment.”
Video and materials now available from recent NAPA Advisory Council meeting
The Advisory Council on Alzheimer’s Research, Care, and Services held a virtual meeting on January 30 and 31. The Advisory Council received presentations on issues related to clinical practice and plans for advanced care planning, and reviewed the impact of new drug approvals and focus on risk reduction and social determinants of health. The National Institute of Neurological Disorders and Stroke (NINDS) presented on gaps and opportunities from the 2022 ADRD Summit, and other federal agencies will provided updates. Full meeting materials now are available, including video of all presentations, public comments, and Advisory Council discussions.
Report on CMS expanded use of Coverage with Evidence Development
The Alliance for Aging Research has published a new report, Façade of Evidence: How Medicare’s Coverage with Evidence Development Paradigm Rations Care and Exacerbates Inequity, which provides an overview of Coverage with Evidence Development (CED), CED’s deficiencies and harmful consequences, and how recent application of CED by the Centers for Medicare and Medicaid Services (CMS) set a dangerous precedent for future Medicare coverage. (An executive summary is available here.) According to the report, CMS increasingly is employing CED to restrict access to drugs, biologics, diagnostics, and medical devices approved by the FDA.
White paper examines urgency for Alzheimer’s policy solutions including innovation, treatment access, and caregiving
A new Alliance for Patient Access white paper, “Overburdened by Alzheimer’s: The Need for Care Innovation and Access,” highlights the disease’s burden and explores policies that could improve patient care. While no cure exists, treatment can slow Alzheimer’s disease progression and relieve patients’ symptoms. The paper identifies several policy solutions to help patients access innovative treatments and effective care:
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- Better coverage. Health plans can improve coverage for screenings, like PET scans and blood biomarker tests, to improve patients’ opportunities to benefit from a timely and accurate diagnosis.
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- Ongoing research. Funds can be invested for more research into disease-modifying therapies, and insurers can ensure such treatments are accessible to patients as they become available.
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- Caregiver support. Policymakers can collaborate to better support and resource caregivers.
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- Long-term care solutions. Policy solutions can make both at-home and residential care more accessible and affordable.
Hope for an Alzheimer’s cure remains. But in the meantime, the paper concludes, the nation can’t afford simply to wait.
Fact sheet explains how to protect dually eligible older adults when Medicaid public health emergency flexibilities end
Starting this Spring, millions of older adults who are dually eligible for Medicare and Medicaid will face redeterminations of their Medicaid eligibility, a process that had been suspended during the COVID-19 Public Health Emergency (PHE). Emergency flexibilities in delivery of Medicaid services also will begin to expire. This process will present significant challenges for states and for dually eligible for individuals who, compared to Medicare-only enrollees, have higher rates of disability and require more assistance with activities of daily living, experience higher rates of poverty leading to housing instability, and often need communication accommodations due to disability or limited English proficiency. A new Justice in Aging fact sheet, “Unwinding Medicaid Continuous Coverage Protections: Implications and Advocacy for Individuals Dually Eligible for Medicare and Medicaid,” provides information about the “unwinding” process and identifies steps that advocates can take with their states and partners to address the specific challenges facing dual eligible individuals during this transition.
In a related development, a new Kaiser Family Foundation issue brief, “Understanding the Role of Medicaid Managed Care Plans in Unwinding Pandemic-Era Continuous Enrollment: Perspectives from Safety-Net Plans,” shares how states can partner with Medicaid managed care organizations (MCOs) to prepare beneficiaries for the unwinding process. MCOs deliver care to more than two thirds of Medicaid beneficiaries.
Study finds correlation between care quality and online ratings for assisted living communities
A study recently published in the Journal of the American Geriatrics Society found that residents who live in assisted living communities with high online ratings spent more time at home—and less time in hospitals, nursing homes and other institutional settings—compared with those who live in assisted living communities that had no or low ratings. The study, which included 59,831 Medicare beneficiaries in 12,143 assisted living communities, was based on Google searches conducted on assisted living communities between 2013 and 2017 and linked to 2018–2019 Medicare data. Study authors observed that the absence of state or federal mandatory reporting requirements for assisted living communities, may leave customers to make decisions based on price and amenities rather than on vetted and comparative data regarding quality.
NTG issues advisory on over-medication of persons with intellectual disability
The National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and the Health Matters Program at the University of Illinois Chicago have issued a new advisory, “Over-Medication and Older Adults with Intellectual Disability: Risks for Brain Health,” which cautions users and families about several issues that arise from over-prescription and over-medication. The advisory offers suggestions for actions that primary care practitioners may undertake to review medications and their impact, as well as what families may do to become better informed and request medication reviews. The National Institute on Aging (NIA) and other organizations have noted that too often there is an accumulation of medications taken by older adults, and some of these medications may be no longer necessary or result in adverse effects. Studies show that many adults with intellectual disability are on numerous medications over their lifetime. Among older adults, some of these medications are still being taken even if unnecessary, others taken may cause behavioral problems or adverse health effects. Some taken for long periods may lead to cognitive problems and possibly dementia. The advisory notes a critical distinction between the use of ‘appropriate polypharmacy,’ which involves the prescribing of multiple medications that are clinically necessary and appropriate for the patient, and ‘inappropriate polypharmacy,’ which involves being prescribed many medications which if taken at the same time can be harmful if taken for too long, in an questionable dosage, and without considering drug interactions.
Additional Reads
- Predictors of cognitive functioning trajectories among older Americans: A new investigation covering 20 years of age- and non-age-related cognitive change (read here)
- Apathy as a Predictor of Conversion from Mild Cognitive Impairment to Alzheimer’s Disease: A Texas Alzheimer’s Research and Care Consortium (TARCC) Cohort-Based Analysis (read here)
- Machine Learning Selection of Most Predictive Brain Proteins Suggests Role of Sugar Metabolism in Alzheimer’s Disease (read here)
- Integrative in situ mapping of single-cell transcriptional states and tissue histopathology in a mouse model of Alzheimer’s disease (read here)
- When Perivascular Macrophages Spew SPP1, Microglia Eat Synapses (read here)
- Effect of long-term caloric restriction on DNA methylation measures of biological aging in healthy adults from the CALERIE trial (read here)
- Short-Term and Long-Term Sensitization Differentially Alters the Composition of an Anterograde Transport Complex in Aplysia (read here)
- Obesity-Associated Neurodegeneration Pattern Mimics Alzheimer’s Disease in an Observational Cohort Study (read here)
- Proton Pump Inhibitor Use and Risk of Dementia in Older Adults: A Systematic Review (read here)
- Costs During the Last Five Years of Life for Patients with Clinical and Pathological Confirmed Diagnosis of Lewy Body Dementia and Alzheimer’s Disease (read here)
- Dementia care programs help, if caregivers can find them (read here)
- No Easy Answers on Clinical Meaningfulness of Alzheimer’s Treatments (read here)
- Payment For Comprehensive Dementia Care: Five Key Recommendations (read here)
- Three New Prescription Drug Innovation Models Latest Action on Drug Pricing (read here)
- Risk of Discharge to Lower-Quality Nursing Homes Among Hospitalized Older Adults With Alzheimer Disease and Related Dementias (read here)
- Rethinking how we train caregivers for people with dementia (read here)
- More Pain, More Burdens: Researchers Find Link between Chronic Pain and Dementia (read here)
- Could Alzheimer’s be caused by an infection? (read here)
- Food insecurity may increase cognitive decline in older adults (read here)
- Research suggests link between low-quality education, dementia (read here)
- New research aims to understand why women more likely to develop Alzheimer’s disease (read here)
- Multi-country dementia study shows women’s greater risk may be linked to disadvantage (read here)
- Scientists find genetic Alzheimer’s risk factor tied to African ancestry (read here)
- Trans people more likely to have long-term conditions like dementia and autism, major study finds (read here)
- Senators call on Medicare to offer broad coverage of Alzheimer’s treatments as public pressure grows (read here)
- Study Suggests Fructose Could Drive Alzheimer’s Disease (read here)
- Updated: FDA adds warning of ‘larger areas of bleeding’ in brain to Biogen’s Aduhelm label (read here)
- Watch Your Step! Balance Ability Predicts Cognitive Impairment (read here)
- The ‘Tipping Point’ Toward Alzheimer’s (read here)
- Rethinking The Future Of Dementia Care (read here)
- Understanding the Link Between Personal Finances and Early Alzheimer’s (read here)
- Spending time in nature may protect against the risk of dementia (read here)
- California Dangles Bonuses for Nursing Homes That Add Staff (read here)
- New brain atlases and digital tools will make brain research more efficient (read here)
TAKE ACTION | NEWS | LEGISLATION
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January, 2024 News
Congress extends appropriations CR
Congress has passed, and the President has signed, a new appropriations continuing resolution (CR) covering Agriculture-FDA, Energy-Water, Military Construction-VA, and Transportation-HUD until March 1, and the remaining eight appropriations bills (including Labor-HHS and Commerce, Justice, Science) until March 8. While congressional leaders have agreed on a $1.66 trillion spending cap for Fiscal Year 2024, they continue negotiating how the funds will be distributed among federal agencies and programs. Earlier this month, the LEAD Coalition joined with nearly 1,100 organizations on a Coalition for Health Funding letter urging Congress to reject any full-year CR that would result in cuts to non-defense discretionary (NDD) programs and instead adopt the bipartisan Senate funding framework for the Fiscal Year 2024 spending agreement.
For additional details and analysis, read articles from The Hill, Roll Call, and the Washington Post.
FDA and CMS issue joint statement on oversight of laboratory developed tests
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement reiterating mutual support of the FDA’s oversight of laboratory developed tests (LDTs), including the analytical and clinical validity of these tests. LDTs help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure these tests work and that patients along with health care providers are able to have warranted confidence that laboratory tests work. Therefore, last October, the FDA issued a notice of proposed rulemaking (Docket No. FDA-2023-N-2177) to help ensure the safety and effectiveness of LDTs by phasing out the FDA’s current approach to LDTs. If finalized, LDTs generally would fall under the same enforcement approach as other tests. CMS supports the FDA’s proposal.
CMS details American Rescue Plan state spending plans for HCBS
The Centers for Medicare & Medicaid Services (CMS) has released state spending plan summaries for section 9817 of the American Rescue Plan Act of 2021 (ARP). The spending plan summaries illustrate how states expect to spend $36.8 billion on activities to enhance, expand, or strengthen home and community-based services (HCBS) under Medicaid. Activities focus on workforce recruitment, retention, and training, quality improvement, reducing or eliminating waiting lists, expansions of the use of technology, opportunities to support caregivers, and ways to address social determinants of health and promote equity.
Three new members join USPSTF
The Agency for Healthcare Research and Quality (AHRQ) has appointed three new members to the U.S. Preventive Services Task Force (USPSTF) who will serve four-year terms, beginning this month. Dr. Sei Lee is a professor of medicine in the Division of Geriatrics at the University of California, San Francisco, and the Senior Scholar for the San Francisco Veterans Affairs Quality Scholars fellowship. Dr. Lee also chairs the American Geriatrics Society Quality and Performance Measurement Committee. He is a geriatrician and palliative care physician and has cared for patients in the clinic, hospital, and nursing home settings. Dr. Tonette Krousel-Wood is a professor and the Jack Aron endowed chair in primary care medicine in the Tulane School of Medicine Department of Medicine. She is the founding director of the Tulane Center for Health Outcomes, Implementation, and Community Engaged Science (CHOICES). She serves in several leadership roles at Tulane, including as the associate provost for the health sciences, senior associate dean of faculty in the School of Medicine, and associate dean for public health and medical education. Dr. Sarah Wiehe is the Jean and Jerry Bepko professor of pediatrics and associate dean of community and translational research at Indiana University School of Medicine. She is a research scientist at the Regenstrief Institute and adjunct professor of epidemiology at Fairbanks School of Public Health at Indiana University. Dr. Wiehe co-directs the Indiana Clinical and Translational Sciences Institute and leads its community engagement program. Full biographies for the new members and all USPSTF members are available here. AHRQ is accepting nominations until the March 15 deadline for members to begin service in 2025.
LEAD Coalition welcomes new member organization
The LEAD Coalition recently welcomed TauRx as its newest member organization. TauRx was founded in 2002 in Singapore, with primary research facilities and operation based in Aberdeen, UK. The company has dedicated the past two decades to developing treatments and diagnostics for Alzheimer’s and other neurodegenerative diseases due to tau protein aggregation pathology. TauRx will contribute to addressing this unmet need with data from the completed Phase 3 LUCIDITY trial and pursuit of regulatory approvals in line with its overall plans to make hydromethylthionine mesylate (HMTM) available to patients and pursue clinical development in other related neurodegenerative diseases.
ADvancing States publishes report on adult protective services
ADvancing States has published findings from the 2022 national survey of Adult Protective Services (APS) Programs in the report Adult Protective Services in 2022: Responding to Evolving Needs in a Changing Environment. ADvancing States conducted this survey to assess the current state of APS programs and identify trends related to topics such as caseload, staff retention, and client assessment. Additionally, there was a special focus placed on clients experiencing self-neglect. This report describes programmatic elements of APS, focuses on the people that the programs serve, identifies needed services, and explores opportunities to expand APS’ relationship with Medicaid.
NCAL issues review of state assisted living regulations
The National Center for Assisted Living (NCAL) recently issued its annual Assisted Living State Regulatory Review, which summarizes key selected state requirements for assisted living licensure or certification. The review provides information for every state and the District of Columbia on topics such as which state agency licenses assisted living, recent legislative and regulatory updates affecting assisted living, scope of care, limitations of services, staffing, and training. The report also includes requirements for communities that offer housing and person-centered supportive and/or health care services to older adults and people with disabilities, but may use a different term than assisted living.
High-quality nursing home dementia care is not only a matter of adding staff
Additional staffing alone will not be sufficient to bridge the quality-of-care and health outcome disparities among nursing home facilities with varying percentages of residents with dementia, according to a first-of-its-kind study led by the University of California, Irvine. Specialized training, an easy-to-navigate environment and staff stability are also critical to meeting the unique challenges presented by this population. The findings, recently published online in the journal Health Services Research, indicate that increased staffing generally improves outcomes for all patients but that at any given level of staffing, discrepancies between high- and low-dementia facilities remain. The impact on care differed by percentage of residents with dementia and various outcomes, ranging from daily activities such as independently bathing, dressing and eating to the number of emergency room visits and incidents of pressure sores. Researchers conducted regression analyses on a national sample of nursing homes between 2017 and 2019, drawing on a variety of datasets, including Medicare claims and the Centers for Medicare and Medicaid Services’ Payroll Based Journal. Independent variables included staff hours per resident-day and dementia population percentage, controlling for other resident and facility characteristics. Separate linear models were utilized to predict six long-term facility-level outcomes.
For Dementia Prevention, Sleep Quality in Midlife Matters More
A new study reveals that quality of sleep, not quantity, may play a part in the development of dementia decades before symptoms start. Unlike previous research that has primarily focused on sleep disturbance and cognitive impairment in late life, the 526 participants at the start of this study had an average age of 40. The researchers used a wrist activity monitor to record bedtime “sleep fragmentation,” which took into account the amount of time participants were immobile and the amount of time they were moving. After tracking the participants’ sleep habits and evaluating their cognitive performance years later, the researchers found no association between cognition and sleep duration, in analyzing both self-reports and data from the wrist activity monitors. In contrast, those with higher levels of fragmented sleep were found to be up to three times as likely to score below average in cognitive testing as those with lower levels of fragmented sleep, when adjusted for factors like education, depression, body mass index, diabetes and hypertension. The participants were part of CARDIA (Coronary Artery Risk Development In young Adults), a National Institutes of Health study. Over half were female; 56% were white and the remainder were Black. Their sleep habits were assessed over a three day-period on two occasions, approximately one year apart, and cognitive testing took place about 11 years later.
Additional Reads
- Association Between Sleep Quantity and Quality in Early Adulthood With Cognitive Function in Midlife (read here)
- A type of dementia that hits the brain of men and women differently (read here)
- Enhancing foveal avascular zone analysis for Alzheimer’s diagnosis with AI segmentation and machine learning using multiple radiomic features (read here)
- Thinning of brain region may signal dementia risk 5-10 years before symptoms (read here)
- Could Bizarre Visual Symptoms Be a Telltale Sign of Alzheimer’s? (read here)
- ‘It was really scary’: In the battle against dementia, support for caregivers is crucial (read here)
- Research into the nature of memory reveals how cells that store information are stabilized over time (read here)
- New cause of neuron death in Alzheimer’s discovered (read here)
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Definition of a Threshold for the Plasma Aβ42/Aβ40 Ratio Measured by Single-Molecule Array to Predict the Amyloid Status of Individuals without Dementia (read here)
- Alzheimer proteopathic tau seeds are biochemically a forme fruste of mature paired helical filaments (read here)
- New links between late-onset Alzheimer’s disease and the immune system (read here)
- Research evaluates how retina could yield early Alzheimer’s disease diagnosis (read here)
- Police Pilot New Tactics for People With Dementia as Advocates Urge Compassion (read here)
- Dementia risk factors differ among ethnicities (read here)
- Synthetic memories: Piecing together the past with AI (read here)
- Research reveals new hope for obesity-induced heart disease (read here)
- The Accelerated Approval Regulatory Pathway With the USA FDA Commissioner Robert Califf (read here)
- Senate to examine walkaway deaths in assisted-living facilities (read here)
- Monitoring synaptic pathology in Alzheimer’s disease through fluid and PET imaging biomarkers: a comprehensive review and future perspectives (read here)
- Exploring the Role of Brexpiprazole in Alzheimer Dementia Agitation (read here)
- Statins and risks of dementia among patients with heart failure: a population-based retrospective cohort study in Hong Kong (read here)
- TREM2 variants that cause early dementia and increase Alzheimer’s disease risk affect gene splicing (read here)
- A Brief Update on Alzheimer’s Diagnosis and Treatment (read here)
- Association of long-term exposure to various ambient air pollutants, lifestyle, and genetic predisposition with incident cognitive impairment and dementia (read here)
- Combining two techniques could spot Alzheimer’s disease sooner (read here)
- Neurosurgeon works to slow Alzheimer’s progression, treat addiction with cutting-edge technology (read here)
- Evidence grows of air pollution link with dementia and stroke risk (read here)
- Dementia-friendly tourism is on the rise—here’s why it’s so important (read here)
- Flagging Dementia Patients for Better Hospital Care (read here)
- Different biological variants discovered in Alzheimer’s disease (read here)
- Blood tests can help diagnose Alzheimer’s — if they’re accurate enough. Not all are (read here)
- Generative Artificial Intelligence Models Effectively Highlight Social Determinants of Health in Doctors’ Notes (read here)
- Naomi Feil, Who Transformed Dementia Care, Dies at 91 (read here)
- Buck Scientists Identify How Dietary Restriction Slows Brain Aging & Increases Lifespan (read here)
- Is the Montreal cognitive assessment culturally valid in a diverse geriatric primary care setting? Lessons from the Bronx (read here)
- Study: Amyloid-β protein affects cognitive decline after small-sized cerebral infarction (read here)
- Cerebrospinal fluid proteomics in patients with Alzheimer’s disease reveals five molecular subtypes with distinct genetic risk profiles (read here)
- A common marker of neurological diseases may play role in healthy brains (read here)
- “Exhausted” immune cells may drive Alzheimer’s (read here)
- Brain areas lipidomics in female transgenic mouse model of Alzheimer’s disease(read here)
- Molecular Biomarkers to Diagnose Vascular Cognitive Impairment and Dementia (read here)
- Is It a Quirky Behavior or Alzheimer’s? (read here)
- How Do You Explain Dementia to a Child? (read here)
- Neural stem cell homeostasis is affected in cortical organoids carrying a mutation in Angiogenin (read here)
- Upping the Ante for Predicting the Success of Alzheimer Disease Treatments (read here)
- Similar Risk Factors Found for Young- and Late-Onset Dementia (read here)
- Alzheimer’s Disease: The Past, Present, and Future of a Globally Progressive Disease (read here)
- Hearing loss increases the risk of dementia (read here)
- Hearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults (read here)
- My Parents’ Dementia Felt Like the End of Joy. Then Came the Robots. (read here)
- Cryptic splicing of stathmin‑2 and UNC13A mRNAs is a pathological hallmark of TDP‑43‑associated Alzheimer’s disease (read here)
- Ultrasound Blood–Brain Barrier Opening and Aducanumab in Alzheimer’s Disease (read here)
- Football linked to damage of white matter in brain, a marker of dementia (read here)
- NIA at 50: Celebrating aging research advances and career opportunities (read here)
- Clinical staging of behavioral and psychological symptoms of dementia (read here)
- Association Between Sleep Quantity and Quality in Early Adulthood With Cognitive Function in Midlife (read here)
- Balancing Autonomy And Public Safety: A Call For Medical And Regulatory Oversight Of Drivers With Cognitive Decline (read here)
- Atypical instantaneous spatio-temporal patterns of neural dynamics in Alzheimer’s disease (read here)
- Native PLGA nanoparticles attenuate Aβ-seed induced tau aggregation under in vitro conditions: potential implication in Alzheimer’s disease pathology (read here)
- Alzheimer Agent Lomecel-B Meets Primary End Point in Phase 2a CLEAR MIND Study (read here)
- Deep Brain Stimulation May Benefit Patients With Alzheimer Disease, But More Research Is Needed (read here)
- Novel Alzheimer’s Trials Evaluate Senolytics, Semaglutide, CRISPR, and More (read here)
- Androgen deprivation therapy for prostate cancer and neurocognitive disorders: a systematic review and meta-analysis (read here)
- An ensemble learning model for continuous cognition assessment based on resting-state EEG (read here)
- Heterogeneous factors influence social cognition across diverse settings in brain health and age-related diseases (read here)
- Association between surgery and rate of incident dementia in older adults: A population‐based retrospective cohort study (read here)
- scMD facilitates cell type deconvolution using single-cell DNA methylation references (read here)
- Tripartite motif-containing protein 11 (TRIM11): a novel weapon against Alzheimer’s disease (read here)
- Alzheimer’s: ‘Cultivating hope is an act of resilience’ (read here)
December, 2023 News
HHS releases National Alzheimer’s Plan 2023 Update
U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra has released HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition. The plan is developed with input from agencies across HHS and other federal departments as well as recommendations from the Advisory Council, whose members include healthcare providers, researchers, caregivers, individuals living with dementia, state representatives, and advocates. For additional information, see the HHS statement.
FDA publishes three new guidances on real world evidence and data
The U.S. Food and Drug Administration (FDA) has published a series of guidances to help advance real world evidence (RWE) and real world data (RWD) and recently published three additional guidances in this series:
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, which updates and clarifies how the FDA evaluates RWD to determine if it is sufficient to be used in regulatory decision making for medical devices and provides expanded recommendations for sponsors collecting RWD. (Federal Register Docket No. FDA-2023-D-4395)
- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, which provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. (Federal Register Docket No. FDA-2021-D-1146)
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data, which addresses considerations for the use of data standards currently supported by the FDA in applicable drug submissions containing study data derived from RWD sources. (Federal Register Docket No. FDA-2021-D-0548)
Supporting a robust data infrastructure, developing new methods and analytical tools, and integrating RWE with traditional clinical trial evidence will require collaboration across the clinical care, research and technology sectors, in addition to direct involvement of patients. To help in this context, the FDA is supporting research or demonstration projects that seek to improve the quality of RWD and RWE. Strengthening systems for generating and gathering new and better data and analyzing those data is vital to provide reliable evidence to inform and improve the many decisions made by consumers, patients, families, clinicians and regulators. The FDA already is capable of reviewing submissions that include or rely entirely on RWD. Enabling advanced data analytics, including RWD, also is incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. Ongoing agency initiatives will continue to promote awareness of, and consistency in, reviewing submissions with RWD.
FDA issues final guidance for rare disease drugs and biologics
The U.S. Food and Drug Administration (FDA) has issued final guidance to assist sponsors of drugs and biological products for treatment of rare diseases in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development. This guidance, entitled “Rare Diseases: Considerations for the Development of Drugs and Biological Products,” finalizes the draft guidance entitled “Rare Diseases: Common Issues in Drug Development” issued on February 1, 2019. This final guidance addresses important aspects of drug and biological product development to support the proposed clinical investigation(s), including nonclinical pharmacology/toxicology; trial design and endpoint considerations to ensure quality and interpretability of data; standard of evidence to establish safety and effectiveness; and drug manufacturing considerations during drug development. Changes made from the draft to the final guidance took into consideration comments received. Major changes include the removal of the natural history section (because this is addressed in a separate guidance), additional considerations regarding nonclinical studies, information on the use of external controls and early randomization, a section discussing safety considerations, information on changes to drug substance or manufacturing process, and sections discussing participation of patients/patient groups in drug development programs and pediatric considerations in rare disease drug development. For additional details, see the Federal Register notice (Docket No. FDA-2015-D-2818).
CMS issues information bulletin on HCBS worker registries
The Centers for Medicare & Medicaid Services (CMS) has released an information bulletin outlining how states can use worker registries for Medicaid-funded home and community-based services (HCBS) to ensure beneficiaries have awareness of, and access to, qualified workers to deliver these critical services. The guidance focuses on building and maintaining worker registries — worker management platforms that make qualified health workers easier to find — so more individuals receiving Medicaid-covered services can get care in a setting of their choice. The guidance also notes that significant federal funding is available through the American Rescue Plan (ARP) to help states build these registries. CMS also released data on how enhanced funding for HCBS, provided through the ARP, has been invested to strengthen access to HCBS nationwide. The funding includes investments to help retain, expand, and train the direct care workforce, as well as investments to support family caregivers and reduce or eliminate waitlists for community-based care.
Report recommends action to address the direct care workforce shortage
The Bipartisan Policy Center has unveiled a report, Addressing the Direct Care Workforce Shortage: A Bipartisan Call to Action, highlighting the critical shortage of direct care workers in the United States and underscoring the urgent need for federal policy reforms to address this escalating crisis. Addressing these challenges is critical to not only ensuring a robust direct care workforce, but also to promoting gender and racial equity, as the current workforce is comprised disproportionately of women (86%), people of color (60%), and immigrants (25%). This moment also presents an important opportunity for federal policymakers to improve care access and quality while making progress in fully integrating individuals with disabilities into the community, as required by the Supreme Court in Olmstead v. L.C., 527 U.S. 581 (1999).
This report includes bipartisan legislative and administrative federal policy solutions to (1) promote retention of direct care workers through reforms that encourage more supportive work environments, including assisting unpaid caregivers who incur significant financial burdens while relieving pressure on the paid workforce; (2) increase the number of workers through domestic and immigration policy reforms; and (3) improve standardized data collection and publicly available data on the direct care workforce to measure the effects of these efforts and inform evidence-based policymaking.
Serotonin loss may contribute to cognitive decline in early stages of Alzheimer’s disease
Comparing PET scans of more than 90 adults with and without mild cognitive impairment (MCI), researchers found that relatively lower levels of serotonin in parts of the brain of those with MCI may play a role in memory problems including Alzheimer’s disease. The findings, published in the Journal of Alzheimer’s Disease, support growing evidence that measurable changes in the brain happen in people with mild memory problems long before an Alzheimer’s diagnosis and may offer novel targets for treatments to slow or stop disease progression. The investigators cautioned that their study showed a correlation between lower serotonin transporter levels and memory problems in MCI and was not designed to show causation or the role of serotonin in the progression from MCI to AD. To answer these questions, further research is needed to study over time healthy controls and individuals with MCI to demonstrate the role of serotonin in disease progression.
Additional Reads
- Alzheimer’s Microglial Risk Gene INPP5D Revs Up Inflammasome (read here)
- The healthcare system continues to discriminate against Alzheimer’s patients (read here)
- Dementia has allowed my mum to live in the present. If she can forget, then maybe so can I (read here)
- Daily learning test can detect Alzheimer’s disease-related changes in memory among cognitively normal older adults (read here)
- Negative Wealth Shock and Cognitive Decline and Dementia in US Adults (read here)
- Alcohol misuse and loneliness ‘increase risk of early-onset dementia’ (read here)
- Plaques Kick Neocortical Neurons into Overdrive, Entangling Tau (read here)
- Risk of young-onset dementia could be reduced through targeting health and lifestyle factors (read here)
- Bolstering our sense of smell may reduce the risk of dementia (read here)
- How these six simple acts could reduce your risk of Alzheimer’s (read here)
- New Atlas Charts Mouse Brain in Exquisite Detail (read here)
- Predicting Alzheimer’s Dementia in Oldest of the Old (read here)
- Midlife blood test may predict cognitive decline, Alzheimer’s in later life (read here)
- ‘Slide-tags’ Method Sharpens Spatial Transcriptomics (read here)
- Home-Delivered Meals and Nursing Home Placement Among People With Dementia (read here)
- Digital training programme improves quality of life for care residents with dementia – even during the Covid-19 pandemic (read here)
- Finding that statins could slow dementia stimulates further research (read here)
- New treatment reverses Alzheimer’s disease signs, improves memory function in preclinical study (read here)
- “They Will Come at Me”: New Study Investigates Fear of Retaliation in America’s Nursing Homes (read here)
- Common drug for cardiac failure jams a debated blood test for Alzheimer’s disease (read here)
- Audiovisual gamma stimulation for the treatment of neurodegeneration (read here)
- Taking out the cellular trash (read here)
- What You Can Do Now to Prevent Memory Loss (read here)
- Alzheimer’s Discovery Reveals Dire Effect of Toxic Tau Protein (read here)
- How one designer is helping dementia patients unlock forgotten memories (read here)
- APOE Christchurch Variant Tames Tangles and Gliosis in Mice (read here)
- Serum proinsulin levels as peripheral blood biomarkers in patients with cognitive impairment (read here)
- Dozens of assisted-living residents died after wandering away unnoticed (read here)
- The iceberg of dementia risk: empirical and conceptual arguments in favor of structural interventions for brain health (read here)
- Cerebral organoids with chromosome 21 trisomy secrete Alzheimer’s disease-related soluble aggregates detectable by single-molecule-fluorescence and super-resolution microscopy (read here)
- Trends in Incident Dementia Diagnosis Before and After Risk Adjustment (read here)
- Polygenic Scores Point to Microglia, Astrocytes in Alzheimer’s Pathogenesis (read here)
- Cerebral organoids with chromosome 21 trisomy secrete Alzheimer’s disease-related soluble aggregates detectable by single-molecule-fluorescence and super-resolution microscopy (read here)
- Human-derived air–liquid interface cultures decipher Alzheimer’s disease–SARS-CoV-2 crosstalk in the olfactory mucosa (read here)
- Infection with stomach bacteria may increase risk of Alzheimer’s disease (read here)
- Stigma and language barriers complicate treating Hispanics with Alzheimer’s disease (read here)
- Immunotherapies for Alzheimer’s disease (read here)
- How Holiday Rituals Can Comfort Grieving Family Caregivers (read here)
- How to Donate Your Brain to Science: For Dementia Families, It’s a Complex Process (read here)
- Saliva: A means to detect pain in people with dementia (read here)
- CSIRO tools used to discover two new genetic variants for Alzheimer’s disease (read here)
- A new study that links specific personality traits to dementia risk could open the door for new approaches to prevention and treatment. (read here)
- Are T Cells to Blame for Cognitive Impairment Caused by Hypertension? (read here)
- Oligodendrocytes and neurons contribute to amyloid-β deposition in Alzheimer’s disease (read here)
- How CRISPR gene editing could help treat Alzheimer’s (read here)
- Clues to preventing Alzheimer’s come from patient who, despite genetics, evaded disease (read here)
- Using deep long-read RNAseq in Alzheimer’s disease brain to assess medical relevance of RNA isoform diversity (read here)
- Nanoparticle-delivered RNA reduces neuroinflammation in lab tests (read here)
- Study Reveals a Protein Called Snail May Play a Role in Healing Brain Injury (read here)
- Alzheimer’s in one sibling raises risk of shortened lifespan in others (read here)
- Dysfunctional muscle mitochondria linked to higher dementia risk (read here)
- Studies have ramifications for Alzheimer’s drug development, immunotherapies (read here)
- Could visiting a museum be the secret to a healthy life? (read here)
- Study Shows How Sex Differences Play a Role in Alzheimer’s (read here)
- Changes in the Diagnostic Process of Alzheimer Disease: A New Era of Blood-Based Approaches (read here)
- Researchers Determine Structural Basis for ApoE-Aβ Interactions (read here)
- Preparing for a new chapter: disease modifying treatments for early Alzheimer’s disease (read here)
- Study Suggests Serotonin Loss May Contribute to Cognitive Decline in the Early Stages of Alzheimer’s Disease (read here)
- Could fasting reset the body’s clock and protect the brain against Alzheimer’s? (read here)
- More people with dementia opting to age in place over senior living (read here)
- Light Therapy Shines in Treating Alzheimer’s Sleep and Mood Issues (read here)
- Why do some older adults show declines in their spatial memory? (read here)
- TAF15 amyloid filaments in frontotemporal lobar degeneration (read here)
- Twice daily electrical stimulation may boost mental processes in Alzheimer’s disease (read here)
- HKBU-led research develops novel drug delivery system for Gouteng compound for Alzheimer’s disease treatment (read here)
- New Alzheimer Europe publication highlights continuing inequalities in access to dementia care and treatment across Europe (read here)
- Study reveals dementia patients may benefit from listening to personalized music (read here)
- Immune Protein May Induce Dementia Unrelated to High Blood Pressure (read here)
- Efficacy and Safety of Cilostazol in Mild Cognitive Impairment (read here)
- Salty immune cells surrounding the brain linked to hypertension-induced dementia (read here)
- Desperate Families Search for Affordable Home Care (read here)
- Housing Instability Tied to Higher Risk for Dementia Diagnosis (read here)
- Longitudinal Sleep Patterns and Cognitive Impairment in Older Adults (read here)
- Efficacy and Safety of Cilostazol in Mild Cognitive Impairment (read here)
- Music compensates for altered gene expression in age-related cognitive disorders (read here)
- Hypertensive disorders of pregnancy and the risk of dementia: a systematic review and meta-analysis of cohort studies (read here)
- Two New p-Tau217 Blood Tests Join a Crowded Field (read here)
- Dementia and Postoperative Delirium in Surgical Hip Fracture Patients: Unveiling Contrasting Risk Factors and Implications (read here)
November, 2023 News
Acadia Pharmaceuticals initiates Phase 2 clinical trial for treatment of Alzheimer’s disease psychosis
Acadia Pharmaceuticals Inc. has announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP), for which there is a large unmet medical need and no FDA-approved medication. Of the more than 6.5 million people in the United States living with Alzheimer’s disease, approximately 30% will experience psychosis, commonly consisting of hallucinations and delusions. The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo. The primary endpoint is change from baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions sub-scales (SAPS-H+D) total score at Week 6. The clinical trial sites will enroll seamlessly from Phase 2 into Phase 3. Each of the planned Phase 3 studies will enroll approximately 378 patients with ADP. Patients who complete the study will have the option of participating in a long-term open-label extension study. ACP-204 works primarily as an inverse agonist at the 5-HT2A receptor. For more information about this study contactmedicalinformation@acadia.com.
CMS issues final rule on ownership of nursing facilities
The Centers for Medicare & Medicaid Services (CMS) has released a final rule, “Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Medicare Providers’ and Suppliers’ Disclosure of Private Equity Companies and Real Estate Investment Trusts,” that will implement portions of section 6101 of the Affordable Care Act, requiring the disclosure of certain ownership, managerial, and other information regarding nursing homes. The final rule also defines the terms “private equity company” and “real estate investment trust,” about which information must be disclosed on the Medicare enrollment application. Section 6101(a) of the Affordable Care Act added section 1124(c) to the Social Security Act, establishing requirements for the disclosure of information about nursing home ownership and oversight. Although nursing homes currently must report certain ownership and management data to CMS and the states as part of the Medicare and Medicaid enrollment processes, some of the information under section 1124(c) of the Act previously has not had to be disclosed (e.g., persons who merely furnish cash management services to a skilled nursing facility that is enrolling in Medicare). According to CMS, this additional data will give CMS and the states a more complete background on the organizations and individuals that own, oversee, and facilitate the operations of nursing homes. For additional details, see the CMS statement.
FDA issues final rule on direct-to-consumer prescription drug ads
The U.S. Food and Drug Administration (FDA) has published the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule.” The final rule establishes standards to implement the statutory requirement that certain direct-to-consumer human prescription drug television and radio ads present the drug’s major side effects and contraindications, known as the “major statement,” in a clear, conspicuous, and neutral manner. The standards under the rule include:
- The information uses consumer-friendly language and terms that are easily understandable.
- The audio information in the major statement is at least as understandable as the audio information in the rest of the ad.
- In ads in TV format, the information is presented concurrently using both audio and text (dual modality); to achieve dual modality
- Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio; and
- The text is displayed for a sufficient duration to allow it to be read easily. (For purposes of this standard, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio.)
- In ads in TV format, the information in text is formatted so the information can be read easily.
- The ad does not include audio or visual elements when the major statement is presented that can interfere with understanding the major statement.
Senate confirms new NIH Director
The Senate has confirmed President Biden’s nominee, Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH) in a bipartisan vote. Earlier this year, the LEAD Coalition joined 114 organizations in a letter to Senate leadership urging Dr. Bertagnolli’s confirmation. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Immediately prior to taking office as NIH Director on November 9, Dr. Bertagnolli served as Director of the National Cancer Institute (NCI). For additional information, read the NIH statement and reporting by STAT.
LEAD Coalition welcomes three new member organizations
The LEAD Coalition — the uniting voice of over 260 member and allied organizations working collaboratively to accelerate transformational progress in care and support to enrich the quality of life of those with dementia and their caregivers, detection and diagnosis, and research leading to prevention, effective treatment, and cures — recently welcomed three new member organizations.
Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients living with Alzheimer’s disease (AD) and related neurodegenerative disorders. ALZ-801 (valiltramiprosate) is an investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD. It is designed to block the formation of neurotoxic soluble beta amyloid oligomers causing cognitive decline in Alzheimer’s patients.
Founded in 1988, the National Association of Chronic Disease Directors (NACDD) is a national, nonprofit, professional association that works to improve public health by strengthening state-based leadership and expertise for chronic disease prevention and control in State, Local, Tribal, and Territorial Health Departments. The Association provides a national forum for chronic disease and health promotion professionals. NACDD’s core membership is composed of the 59 State and Territorial Health Department Chronic Disease Directors and their staff who protect the health of the public through primary and secondary prevention efforts and work “upstream” on root causes of chronic conditions. In addition, NACDD unites 7,000 chronic disease professionals across the United States working in state, tribal, and territorial health departments, nonprofits, academia, and the private industry to promote health and to reduce the burden of chronic disease.
Positrigo is a pioneer in nuclear medical imaging technologies. Headquartered in Zurich, Switzerland, the medical device company was founded in 2018 as a spin-off of ETH Zurich. Positrigo’s technology, development, clinical testing and commercialization has been supported by various private investors, the Swiss government and the European Innovation Council. NeuroLF – the company’s first device – is an ultra-compact brain Positron Emission Tomography (PET) scanner which has applications in the assessment of causes of dementias, such as Alzheimer’s disease and other brain related disorders.
PHCOE on Dementia Caregiving releases new resources
The Public Health Center of Excellence (PHCOE) on Dementia Caregiving has released two new resources. A Guide on Advanced Care Planning Resources: For People Living with Dementia and Their Care Partners contains a range of tools, materials, and information related to advanced care planning, including financial, housing, medical, legal, and palliative/hospice care assistance. The guide is intended to be used primarily by people living with dementia and their care partners to help navigate and provide recommendations for effective care, services, and considerations at various stages of cognitive impairment and dementia. Public health agencies may use this guide to raise awareness and promote the use of best practices by distributing the guide to local community organizations, healthcare systems, aging services providers, and health departments for use by their constituents.
Public Health Strategies in Dementia Caregiving: A Toolkit for Public Health Agencies is designed to provide strategies and interventions that public health agencies can implement to support and elevate the work of family dementia caregivers that are consistent with the Healthy Brain Initiative Road Map. The toolkit may be useful for all public health agencies as they set and pursue their dementia caregiving goals, but especially to public health departments that were awarded funding through the BOLD Infrastructure for Alzheimer’s Act as they implement their Alzheimer’s disease and related dementias (ADRD) strategies.
KFF publishes Medicare Advantage 2024 Spotlight
The Kaiser Family Foundation (KFF) has released the issue brief, “Medicare Advantage 2024 Spotlight: First Look,” detailing the organization’s analysis of Medicare Advantage (MA) plans and Part D prescription drug plans (PDPs) available in 2024. According to the analysis, the typical beneficiary has a choice of 43 MA plans as an alternative to traditional Medicare in 2024. This is the same number as in 2023 but more than twice the number of plans that were offered in 2018. Of the 43 MA plans, 36 plans offer Part D drug coverage, on average. Additionally, individuals with traditional Medicare have a choice of 21 Medicare stand-alone PDPs for 2024. The number of D-SNPs (for dually-eligible beneficiaries) has increased substantially over the past five years, nearly doubling from 465 dual SNPs in 2019 to 851 dual SNPs in 2024. Most Medicare Advantage plans are offering extra benefits, such as vision, dental and hearing as they have in previous years. Most Medicare Advantage plans are not offering Special Supplemental Benefits for the Chronically Ill, which are extra benefits available to a subset of a plan’s enrollees, that are not primarily health related, and are specifically for chronically ill beneficiaries. However, more SNP plans than individual plans generally offer these benefits, particularly food and produce (60.0% in SNPs compared to 13.9% in individual plans).
High biological age may increase the risk of dementia
According to results from a Karolinska Institute study, people who have a higher biological age than their actual chronological age have a significantly increased risk of stroke and dementia, especially vascular dementia. The increased risk persists even if other risk factors — such as genetics, lifestyle and socioeconomics — are taken into account. To measure biological age and the link to disease, the researchers used data from the UK Biobank. The study examined a cohort of 325,000 people who were between 40 and 70 years old at the time of the first measurement. Biological age was calculated using 18 biomarkers, including blood lipids, blood sugar, blood pressure, lung function and body-mass index. The researchers then investigated the relationship between these biomarkers and the risk of developing neurodegenerative diseases within a nine-year period. When compared to chronological age, high biological age was linked to a significantly increased risk of dementia, especially vascular dementia, and ischemic stroke.
Additional Reads
- Neuronanomedicine for Alzheimer’s and Parkinson’s disease: Current progress and a guide to improve clinical translation (read here)
- Screening, Assessment, and Pharmacologic Treatment of Mild Cognitive Impairment and Early Alzheimer’s Disease: The Role for Monoclonal Antibodies (read here)
- Dancing Through Dementia: How Movement Aids Memory and Mood (read here)
- Can Health, Lifestyle Changes Protect Elders from Alzheimer’s? (read here)
- Irritability, Agitation and Anxiety in Alzheimer’s Patients Caused by Brain Inflammation, Pitt Study Says (read here)
- Many Americans with dementia can’t get the hospice care they need (read here)
- Alzheimer’s activist Rebecca Chopp recommends testing early for the disease (read here)
- Older adults’ awareness of modifiable risk and protective factors for dementia and interest in eHealth interventions for brain health: a comparison between the Netherlands and Germany (read here)
- Size of brain area linked with cognitive decline – even in people with no other warning signs of Alzheimer’s disease (read here)
- Lowering a form of brain cholesterol reduces Alzheimer’s-like damage in mice (read here)
- Eating More Whole Grains Is Associated With Less Memory Decline in African Americans (read here)
- Applying An Evidence-Based Approach To Comprehensive Dementia Care Under The New GUIDE Model (read here)
- Understanding Donanemab’s Clinical Relevance for Patients With Alzheimer Disease (read here)
- Research finds sex differences in immune response and metabolism drive Alzheimer’s disease (read here)
- Documentary offers empowered approach to dementia and Alzheimer’s disease (read here)
- Social and Behavior Factors of Alzheimer’s Disease and Related Dementias: A National Study in the U.S (read here)
- Food Insecurity, Memory, and Dementia Among US Adults Aged 50 Years and Older (read here)
- Hearing Loss is Associated with Subtle Changes in the Brain (read here)
- Black Patients Less Likely to Receive Alzheimer’s Care, Blocking Access to New Treatments (read here)
- Early study results show virtual reality can bolster caregivers, LTC seniors relationship (read here)
- A Promising Turning Point For Dementia Care: The GUIDE Model (read here)
- How a mutation in microglia elevates Alzheimer’s risk (read here)
- Lab-grown ‘small blood vessels’ point to potential treatment for major cause of stroke and vascular dementia (read here)
- “May the Force (and Size) Be with You”: Muscle Mass and Function Are Important Risk Factors for Cognitive Decline and Dementia (read here)
- Dissociable Effects of Alzheimer’s Disease-Related Cognitive Dysfunction and Aging on Functional Brain Network Segregation (read here)
- Could newborn neurons reverse Alzheimer’s? (read here)
- Gut inflammation associated with age and Alzheimer’s disease pathology: a human cohort study (read here)
- Adult Children Discuss the Trials of Caring for Their Aging Parents (read here)
- Facing Financial Ruin as Costs Soar for Elder Care (read here)
- As the workforce ages, now is the time to normalize dementia care (read here)
- This Wireless, Handheld, Non-invasive Device Detects Alzheimer’s and Parkinson’s Biomarkers (read here)
- Unlocking Blood-Brain Barrier Boosts Immunotherapy Efficacy, Lowers ARIA (read here)
- Lowering blood pressure significantly reduced dementia risk in people with hypertension (read here)
- AI that reads brain scans shows promise for finding Alzheimer’s genes (read here)
- Dysfunctional muscle mitochondria linked to higher dementia risk (read here)
- Recognizing Advanced Alzheimer’s: Signs, Support, and Care (read here)
- Constricting Life Space and Neurodegenerative Disease in Community-Dwelling Older Men (read here)
- Researchers identify new criteria to detect rapidly progressive dementia (read here)
- Scientists tame biological trigger of deadly Huntington’s disease (read here)
- Treat Before ‘Aβ Bothers Tau,’ Scientists Say at CTAD (read here)
- Alzheimer’s Disease and Weight Loss: Why It Happens and What Can Be Done (read here)
- Pharmacogenomics holds promise for personalized dementia therapies (read here)
- Accelerating development of next-generation drugs for Alzheimer’s and related dementias (read here)
- New Culprit in Amyloid Beta Accumulation and Neurodegeneration (read here)
- PET scans may predict Parkinson’s disease and Lewy body dementia in at-risk individuals (read here)
- This dementia-inclusive choir is a happy place for friends and carers (read here)
- The Arts and Advanced Dementia (read here)
- Alzheimer’s Disease: Genetic Variant Can Significantly Raise Risk (read here)
- Agitation That May Happen with Dementia Due to Alzheimer’s Disease (read here)
- Reducing poverty may reduce risk of developing dementia (read here)
- Positive Data for First and Only Treatment Approved for Agitation in Alzheimer Dementia (read here)
- Alzheimer’s Disease: The Winds of Progress (read here)
- High metabolism is an early sign of Alzheimer’s disease (read here)
- America’s Message to Families With Loved Ones Suffering From Dementia: You’re on Your Own (read here)
- To Recruit for Diverse Alzheimer Trials, Go to the People (read here)
- Border Surprise: Glia Limitans Astrocytes Sit on Brain Surface (read here)
- Researchers find the roots of tau tangles in Alzheimer’s disease (read here)
- Virtual community of long-term care and other providers commits to ‘age-friendly’ care guidelines (read here)
- Sweet spot for HRT may reduce dementia risk by nearly a third, study says (read here)
- Being bilingual slows brain ageing, and can prevent Alzheimer’s (read here)
- Brain health in over 50s deteriorated more rapidly during the pandemic (read here)
- Minimum-Staffing Rules for U.S. Nursing Homes — Opportunities and Challenges (read here)
October, 2023 News
CMS removed NCD for amyloid PET to diagnose Alzheimer’s disease
The Centers for Medicare & Medicaid Services (CMS) has announced that it is removing the national coverage determination (NCD) at § 220.6.20, ending coverage with evidence development (CED) for positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors (MACs). The 2013 amyloid PET NCD had resulted in nationwide non-coverage of amyloid PET for a full decade, with the extraordinarily limited exception of coverage (one scan per lifetime) for individuals participating in CED clinical studies.
CMS revises Civil Money Penalty Reinvestment Program
The Centers for Medicare & Medicaid Services (CMS) has issued updated guidance for the Civil Money Penalty Reinvestment Program (CMPRP) for projects to support the quality of care and life for nursing home residents in long-term care facilities certified by Medicare and Medicaid. Under the program, a portion of civil money penalty (CMP) funds for noncompliance is provided to the State to reinvest in activities that will benefit residents to protect and improve their safety and quality of care. The CMPRP revised policies clarify the allowable uses of CMP funds, with maximum funding limits per nursing home and a clear list of the non-allowable uses of CMP funds.
FDA establishes advisory committee on digital health technologies
The U.S. Food and Drug Administration is establishing a new Digital Health Advisory Committee (DHAC) to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. Digital health also includes issues such as decentralized trials, patient-generated health data, and cybersecurity. The DHAC will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. FDA is accepting nominations for DHAC membership until December 11. The committee should be fully operational in 2024.
NIH revises grant review process to improve focus on scientific merit, reduce reputational bias
The National Institutes of Health (NIH) is taking steps to simplify its process to assess the scientific merit of research grant applications and mitigate elements that have the potential to introduce bias into review. The changes will help reviewers focus on the potential for proposed research to advance scientific knowledge and improve human health. Previously, five criteria were scored individually using a common scale. The simplified review framework reorganizes these criteria into three factors; importance of research along with rigor and feasibility will be scored using a common scale while expertise and resources will be evaluated for sufficiency only and not given a numeric score. The simplified review framework will be implemented for grant applications received on or after Jan. 25, 2025.
NIH has been gathering significant feedback from the extramural community on the grant application review process, and last year NIH proposed revisions to the process through a Simplified Framework for NIH Peer Review Criteria initiative. In forming the simplified framework, NIH gathered input through a 2022 Request for Information, receiving more than 800 responses from individuals and scientific societies. Most responses were supportive of the proposed changes, and underscored the need for communication, guidance and resources well in advance of implementation.These changes contribute to NIH’s decade long effort to address potential bias in grantmaking and enable a level playing field. Additionally, these changes will reduce administrative responsibilities of peer reviewers, shifting them to NIH staff, thereby allowing reviewers to focus on the science. NIH is developing a timeline, policy rollout and trainings to support implementation of these changes. Additionally, NIH will compile feedback and conduct data analysis to evaluate the changes over time, allowing for additional modifications as necessary.
New educational resources on dementia diagnosis and treatment in surgical settings
The American College of Surgeons (ACS) recently released a suite of educational resources focused on the accurate, consistent diagnosis and appropriate treatment of dementia and cognitive impairment to promote patient safety, equitable care, and decreased hospital resource use. Resources include:
- Cognitive Impairment Screening – ACS House of Surgery Podcast: This episode features a multidisciplinary panel of experts discussing the importance of preoperative detection of cognitive impairment and dementia in the geriatric population.
- Patient and Caregiver Brochure: This brochure for patients and caregivers covers what to expect when having surgery and includes shared decision-making and treatment choice options based on conditions and surgical needs of patients.
- ACS Bulletin Article: Cognitive Screening in Older Patients May Help Optimize Outcomes: Among older surgical patients, cognitive impairment prior to surgery is prevalent and substantially increases the risk of costly and serious postoperative complications and further cognitive decline. This neurocognitive dysfunction introduces crucial factors into the surgical decision-making process and perioperative care planning, which has a wide-ranging impact on surgeons, patients, caregivers, and other members of the healthcare team.
- Toolkit: Designed for interdisciplinary teams caring for older adults undergoing surgery, this best-practice toolkit covers why preoperative cognitive assessments are important, how to talk to patients about screening cognition, a detailed overview of some varying validated screening tools currently available, and next steps section for when patients screen positive.
- The Impact of Cognitive Impairment on Surgical Decision-Making and the Care Process: Held at the 2023 ACS Quality & Safety Conference, this session featured a panel of experts discussing varying levels of dementia and the importance of screening for cognition in the preoperative setting, processes that can help a physician and patient move beyond passive informed consent to a more collaborative, patient-centered experience, and the pearls and pitfalls of advanced directives.
GAO examines use of CMS data to identify private equity ownership of nursing homes
The U.S. Government Accountability Office (GAO) recently conducted an analysis examining the complexities of using data from the Centers for Medicare & Medicaid Services (CMS) to identify ownership structures within nursing homes, with a particular focus on private equity ownership. The study highlights complexities in nursing home ownership structures and the limitations of CMS data, emphasizing the difficulty in accurately identifying private equity ownership. The report also discusses the implications of these limitations on transparency and oversight within the nursing home industry. To perform this analysis, GAO adopted a comprehensive approach, including reviewing nursing home ownership data from CMS and other sources, examining relevant documentation and research studies, and conducting interviews with CMS officials. to read one page summary and the full GAO analysis.
ADvancing States launches dementia training course
ADvancing States has launched a training course “Identifying and Understanding the Needs of People Living with Dementia and Their Caregivers,” developed in partnership with the Alzheimer’s Association. The course will further participants’ understanding of Alzheimer’s disease and other forms of dementia, and what differentiates these conditions from typical aging. Participants will learn communication strategies to provide telephone support to someone living with early-stage dementia. The course describes the impact that dementia can have on caregivers in order to prepare community resource professionals for empathetic phone interactions. Participants will strengthen their knowledge of resources to assist individuals and caregivers through learning about the role of the Alzheimer’s Association and the support that it offers to those affected by Alzheimer’s and other dementia. To access this free training course, visit the Consumer Access to Services course category on ADvancing States iQ.
ASTHO publishes best practice guide for falls prevention
the Association of State and Territorial Health Officials (ASTHO), with support from the Centers for Disease Control and Prevention (CDC), has published “Expanding Falls Prevention Through Surveillance, Community-Clinical Linkages, and Strategic Planning and Evaluation,” to address the public health impact of unintentional falls among older adults. The guide is intended to be a comprehensive resource for state health departments in understanding how to align current falls prevention efforts to support community-clinical linkages and offer strategies to assist in implementing new efforts to support these linkages.
Unintentional falls are the leading cause of injury and injury death among older adults in the United States. Each year, about 14 million older adults report falls and five million report fall injuries, leading to over $50 billion in medical costs. Older adult falls contribute to more than 900,000 hospitalizations every year. A fall-related hospitalization increases the likelihood of a long-term nursing home admission, creating either a temporary or permanent loss of independence. In 2021, there were nearly 39,000 fall-related deaths among older adults, averaging more than 100 deaths per day.
Chlorhexidine bathing routine reduces infections in nursing homes
According to a study in the New England Journal of Medicine, nursing homes using a chlorhexidine antiseptic soap bathing routine to clean the skin and nose with over-the-counter antiseptic solutions prevents serious infections and reduces the amount of antibiotic resistant organisms, such as methicillin-resistant Staphylococcus aureus (MRSA)..Annually, three million healthcare-associated infections in U.S. nursing homes cause 150,000 hospital admissions and 350,000 deaths. In the study involving nearly 14,000 residents, researchers found that nursing homes using the “decolonization” bathing routine averaged two residents per month avoiding infections that would have required transfer to the hospital. These nursing homes also reduced significantly hospital transfers due to other causes. Nursing homes that used decolonization significant reduced overall prevalence of multidrug-resistant organisms including MRSA, vancomycin-resistant Enterococci, and other bacteria.
In this 18-month study of 28 California nursing homes, researchers compared 14 facilities that continued usual bathing routines to 14 facilities that used decolonization for all residents. Decolonization included using chlorhexidine and a nasal swab with povidone-iodine (iodophor) to remove pathogens from residents’ skin and nose. These two products have been used in healthcare for over 60 years. Adherence to the decolonization bathing routine did not need to be perfect to prevent hospitalization and spread of resistant organisms: 87 percent of nursing home staff used the chlorhexidine as intended and 67 percent used the nasal swab as intended.
Additional Reads
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- Abrupt drop in blood pressure may be an early sign of dementia (read here)
- No Influence of APOE Status on Donanemab Efficacy (read here)
- Number of dementia cases could be 42% higher than previously estimated by 2040 (read here)
- Eisai Plans to Submit BLA for Subcutaneous Lecanemab After Findings Show Promising Results (read here)
- The beginning of the end for Alzheimer’s Dementia? (read here)
- Why Diagnosing Alzheimer’s Early Is So Important (read here)
- Biogen’s tau-lowering drug slows cognitive decline in early study of Alzheimer’s disease (read here)
- New studies find benefits in very early drug treatment of Alzheimer’s (read here)
- Donanemab slows disease progression, reduces amyloid in early symptomatic Alzheimer’s (read here)
- Facing dementia without a diagnosis is crushing. A new program in Kenya offers help (read here)
- Metformin Cessation and Dementia Incidence (read here)
- Do dementia villages actually work? We just don’t know (read here)
- Physicians Are Dramatically Underdiagnosing Early Cognitive Decline, a Precursor to Alzheimer’s (read here)
- Study Suggests Estrogen to Prevent Alzheimer’s Warrants Renewed Research Interest (read here)
- Validating an MRI Biomarker for Early Onset Alzheimer’s Disease (read here)
- Ensuring adequate dementia care: The beginning of the end of Alzheimer’s? (read here)
- Study on Largest Genetic Risk Factor for Alzheimer’s Points Toward New Drug Target (read here)
- Adding lifestyle coaching to treatment decreases cognitive decline in early Alzheimer’s (read here)
- Non-invasive temporal interference electrical stimulation of the human hippocampus (read here)
- Individuals Can Now Request a Blood Test for Alzheimer’s Disease: Why Some Dementia Experts Are Wary (read here)
- The Sporadic Early‐onset Alzheimer’s Disease Signature Of Atrophy: Preliminary Findings From The Longitudinal Early‐onset Alzheimer’s Disease Study (LEADS) Cohort (read here)
- Doubts abound about a new Alzheimer’s blood test (read here)
- Scientists discover links between Alzheimer’s disease and gut microbiota (read here)
- New model provides window into Alzheimer’s disease development (read here)
- We may finally know how cognitive reserve protects against Alzheimer’s (read here)
- Fluctuating blood pressure: a warning sign for dementia and heart disease (read here)
- Clinical Overview: Lecanemab Offers Hope for Patients With Alzheimer Disease (read here)
- Western researchers reveal link between Alzheimer’s disease and sex hormones (read here)
- Adults With ADHD Are at Increased Risk for Developing Dementia (read here)
- Brain fungal infection produces Alzheimer’s disease-like changes (read here)
- Dementia’s financial and family impact: New study shows outsized toll (read here)
- A New Framework for Dementia Nomenclature (read here)
- Deep learning combining FDG-PET and neurocognitive data accurately predicts MCI conversion to Alzheimer’s dementia 3-year post MCI diagnosis (read here)
- In Alzheimer’s, Tau Oligomers in Synapses Act as ‘Eat Me’ Signal (read here)
- Scientists Investigating Alzheimer’s Drug Faulted in Leaked Report (read here)
- Medicare to cover more brain scans related to Alzheimer’s drugs (read here)
- Taking a deep dive into the Alzheimer’s brain in search of understanding and new targets (read here)
- $151M Grant Will Drive New Era in Alzheimer’s Treatments (read here)
- Blood tests needed for widespread Alzheimer’s diagnosis on the way (read here)
- Can we prevent Alzheimer’s? Scientists say new tests and treatments are “a game changer” (read here)
- Bracing for a cloudy NIA budget forecast (read here)
- Certain navigational mistakes could be early signs of Alzheimer’s disease (read here)
- Dementia risk factors pose more danger for ethnic minorities, finds study (read here)
- Advanced imaging may shed light on mechanisms behind Alzheimer’s disease (read here)
- Understanding the Onset of Sporadic Alzheimer’s Disease (read here)
- It May Not Be So Typical: Distinguishing Frontotemporal Dementia From Behavioral Variant Alzheimer’s Disease (read here)
- Is the Eye the Window to Alzheimer’s? (read here)
- Insight: Down syndrome families’ fight for access to Alzheimer’s trials, treatments (read here)
- Mount Sinai Researchers First to Develop Age Prediction Model on Human Brain Tissue Using Artificial Intelligence (read here)
- Study Published by NYMC Researchers in Nature Communications Biology Unveils Crucial Link Between Diet, Inflammation and Alzheimer’s Disease (read here)
- The gene expression changes behind Alzheimer’s disease (read here)
- Could a Faulty Ubiquitin Trigger Amyloid and Tau Deposits? (read here)
- Stunning Detail: Single-Cell Studies Chart Genomic Architecture of AD (read here)
- Possible tool discovered to diagnose common contributor to vascular dementia (read here)
- New AI Technique Helps Find Alzheimer’s Drug Targets (read here)
- Even Moderate Drinking May Be Bad for Brain Health (read here)
- Are people who have long-haul COVID more at risk for Alzheimer’s? (read here)
- Protein that could help defeat Alzheimer’s and increase productive lifespan (read here)
- Study maps brain wave disruptions affecting memory recall (read here)
- Proton pump inhibitors and dementia: A nationwide population‐based study (read here)
- Scientists discover neurons that act as brain ‘glue’ to recall memories (read here)
- Multivariate GWAS of Alzheimer’s disease CSF biomarker profiles implies GRIN2D in synaptic functioning (read here)
- Graphene oxide reduces the toxicity of Alzheimer’s proteins (read here)
- Antibody Therapy Inspired by Patient Case Reduced Tau Tangles in a Preclinical Model of Alzheimer’s Disease (read here)
- Caregiving Through Dementia: a Loving and Difficult Journey (read here)
- Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial (read here)
- Study indicates possible link between chronic stress and Alzheimer’s disease (read here)
- In Forming Long-Term Memories, Vascular Cells are Crucial (read here)
- Parkinson’s Research Buoyed by Alzheimer’s Advances (read here)
- Effect of Periodontal Disease on Alzheimer’s Disease: A Systematic Review (read here)
- Promoting Equity In Clinical Decision Making: Dismantling Race-Based Medicine (read here)
- Caregiver burden in a home hospital versus traditional hospital: A secondary analysis of a randomized controlled trial (read here)
September, 2023 News
288 LEAD Coalition members and allies urge Congress to pass the CHANGE Act
NIH designates people with disabilities as a population with health disparities
On September 26, Eliseo J. Pérez-Stable, M.D., director of the National Institute on Minority Health and Health Disparities (NIMHD), designated people with disabilities as a population with health disparities for research supported by the National Institutes of Health. The decision was made in consultation with Robert Otto Valdez, Ph.D., the director of the Agency for Healthcare Research and Quality, after careful consideration of a report delivered by an NIMHD advisory council, input from the disability community and a review of the science and evidence. A separate report issued in December 2022 by the Advisory Committee to the (NIH) Director (ACD), informed by the work of the Subgroup on Individuals with Disabilities, explored similar issues faced by people with disabilities. The designation is one of several steps NIH is taking to address health disparities faced by people with disabilities and ensure their representation in NIH research. NIH also issued a notice of funding opportunity calling for research applications focused on novel and innovative approaches and interventions that address the intersecting impact of disability, race and ethnicity, and socioeconomic status on healthcare access and health outcomes. NIH also recently issued a Request for Information (RFI) inviting feedback on a proposed update to the NIH mission statement; see the LEAD Coalition’s Take Action page for details on the Mission Statement RFI).
NIMHD is the lead NIH institute on monitoring minority health and health disparities research. Designated populations experience significant disparities in their rates of illness, morbidity, mortality and survival, driven by social disadvantage, compared to the health status of the general population. A health disparity designation helps to encourage research specific to the health issues and unmet health needs of these populations. Other NIH-designated populations with health disparities include racial and ethnic minority groups, people with lower socioeconomic status, underserved rural communities and sexual and gender minority groups.
NIA launches next EUREKA Challenge
The National Institute on Aging (NIA recently announced raw the Pioneering Research for Early Prediction of Alzheimer’s and Related Dementias EUREKA (PREPARE) challenge prize to improve early detection and address diagnosis gaps among racial and ethnic groups that are underrepresented in most clinical studies and databases. To make progress, the challenge aims to address the need for:
- Data from a wider set of sources and types, including data relevant to low-resourced, underserved communities disproportionately impacted by Alzheimer’s disease and related forms of dementia (AD/ADRD) to better understand and address biases in existing data sources;
- Open, shareable data, stored in trusted repositories to determine “distributional robustness” of predictive algorithms; and
- Algorithms that meet “right to explanation” mandates (i.e., if an AI algorithm impacts people, people have a right to an explanation of how AI conclusions were reached).
For additional details about the PREPARE challenge, eligibility, and application instructions, click here.
FDA updates FAQ and issues guidance on advancing real world evidence
The U.S. Food and Drug Administration (FDA) has updated the FAQ about its Advancing Real-World Evidence (RWE) Program. The Program seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements. The Program fulfills an FDA commitment under the Prescription Drug User Fee Act (PDUFA) VII. FDA also has released guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” For a summary of the new guidance, click here.
ACL awards Center of Excellence to align health and social care
The Administration for Community Living (ACL) Office of Network Advancement (ONA) has announced a new award to USAging for the Center of Excellence (COE) to Align Health and Social Care: Enhancing Community-Based Aging and Disability Organizations to Improve Access to Long-Term Services and Supports. The project period runs through August 31, 2026. First-year funding will support development and enhancement of aging and disability organizations supported by ACL to operate as community care hubs (CCHs). A CCH is a community-focused entity that organizes and supports a network of community-based organizations providing services to address health-related social needs, typically as partners with health care or heath system providers.
Through this award, the COE will collaborate with relevant stakeholders to improve access to long-term services and supports through CCHs as part of a broader No Wrong Door (NWD) System. In this first year, the COE will administer and manage competitive sub-awards to an estimated 20 disability and aging organizations to improve their NWD access functions, with specific emphasis on the core function of care transitions and CCH capacity to coordinate referrals across health care and social services, as well as supporting individuals transitioning from hospital to home. The COE will collaborate with ACL and partners to provide technical assistance to support both new and existing CCHs, with an emphasis on organizations in ACL’s aging and disability networks. The COE also will participate in an evaluation designed by ACL’s Office of Performance and Evaluation to assess the impact of CCHs on the delivery and coordination of services that address health-related social needs.
ACL awards Innovation Lab grant to improve falls prevention
The Administration for Community Living (ACL) Office of Performance and Evaluation has announced the creation of the ACL Innovation Lab through an award to the National Council on Aging. The three-year grant will support a collaborative, multi-partner effort to build knowledge and advance fall prevention efforts across the nation. The Lab will conduct research, demonstrations, and evaluations pertaining to falls prevention among older adults, including older adults with disabilities. The award will expand ACL’s existing falls prevention efforts, advancing and disseminating knowledge and practices that prevent falls and address risk factors. The Lab’s primary goals and activities include:
- Developing a taxonomy for falls prevention research.
- Funding a cohort of sub-awards to community-based entities nationwide to conduct research to understand and measure the extent to which existing interventions reduce falls and risk factors.
- Developing a secure, dynamic system to house the data collected and evidence developed by sub-awardees.
- Serving as a national focal point for technical assistance that supports the delivery and scaling of effective falls prevention interventions across the aging network.
CMS to hold Medicare Drug Price Negotiation Program listening sessions
The Centers for Medicare & Medicaid Services (CMS) plans to host a series of patient-focused virtual listening sessions for the Medicare Drug Price Negotiation Program. The sessions are intended to provide opportunities for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations. CMS will host 10 Listening Sessions this fall, one for each of the 10 selected drugs:
- Eliquis: Monday, October 30, 12:00 – 1:30 PM EST
- Enbrel: Tuesday, October 31, 12:00 – 1:30 PM EST
- Entresto: Wednesday, November 1, 12:00 – 1:30 PM EST
- Farxiga: Thursday, November 2, 12:00 – 1:30 PM EST
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill: Friday, November 3, 12:00 – 1:30 PM EST
- Imbruvica: Monday, November 6, 12:00 – 1:30 PM EST
- Januvia: Tuesday, November 7, 12:00 – 1:30 PM EST
- Jardiance: Wednesday, November 8, 12:00 – 1:30 PM EST
- Stelara: Tuesday, November 14, 12:00 – 1:30 PM EST
- Xarelto: Wednesday, November 15, 2:00 – 3:30 PM EST
The sessions are open to the public and will be live streamed. Registration is not necessary to view the livestream. Registration by October 2 is required to make a public statement at one or more of the virtual listening sessions. Because there are limited speaking opportunities during the sessions, CMS encourages the public to submit written input by the October 2 deadline, if interested, in response to the 2023 CMS information collection request about selected drugs and evidence about alternative treatments. Submissions can include data on the selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical need and impacts on specific populations as well as the patient/caregiver experience.
KFF issue brief examines what share of nursing facilities might meet CMS proposed staffing standards
On September 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule (CMS 3442-P) that would create new requirements for nurse staffing levels in nursing facilities. An earlier report by the National Academy of Sciences, Engineering, and Medicine (NASEM) raised concerns about low nursing staff levels in nursing facilities and the impact on the quality of care for nursing home residents. In response to the CMS proposed rule, Kaiser Family Foundation has published an issue brief analyzing the percentage and characteristics of facilities that would meet the proposed requirements for the minimum number of registered nurse and nurse aide hours. The analysis does not evaluate facilities’ ability to comply with other proposed requirements, including the requirement to always have a registered nurse on duty 24/7 or the ability to meet the new reporting and assessment requirements due to data limitations. The analysis uses Nursing Home Compare data, which include 14,591 nursing facilities (97% of all facilities, serving 1.17 million or 98% of all residents) that reported staffing levels in August, 2023. KKF found that:
- Among all nursing facilities, fewer than 20% currently could meet the required number of hours for registered nurses and nurse aides, meaning that over 80% of facilities would need to hire nursing staff.
- 90% of for-profit facilities would need to hire additional nursing staff compared with 60% of non-profit and government facilities.
- The percentage of nursing facilities that would meet the requirements in the proposed rule varies from all in Alaska (100%) to nearly none in Louisiana (1%).
Interest parties may submit public comments to CMS on the proposed rule by the November 6 deadline. Additional information about the public comment opportunity is available on the LEAD Coalition Take Action web page until the comment deadline.
ADI releases World Alzheimer’s Report 2023
Alzheimer’s Disease International has released World Alzheimer Report 2023, which focuses on reducing the risk of dementia and offers a global insight into the ways in which dementia risk factors are experienced. The report examines modifiable and non-modifiable risk factors as well as the benefits of lifelong risk reduction. The report highlights global disparities in an individual’s ability and means to mitigate their risk of dementia, and includes a call to action for governments to provide population-based systemic changes to promote risk reduction and the importance of dementia research. For additional insight, watch the archived webinar.
Additional Reads
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- Specific interneurons are important in aging-associated cognitive decline, study finds (read here)
- Decoding the complexity of Alzheimer’s disease (read here)
- Sitting all day increases dementia risk — even if you exercise (read here)
- “Anti-tangle” molecule could aid search for new dementia treatments, say scientists (read here)
- Ten-year plan to fill dementia knowledge gaps (read here)
- Exploring the Association Between Opioid Use Disorder and Alzheimer’s Disease and Dementia Among a National Sample of the U.S. Population (read here)
- Researchers Connect Alzheimer’s-Associated Genetic Variants with Brain Cell Function (read here)
- Researchers discover how a gene only some of us have may protect against neurodegeneration (read here)
- Meet the Two New Biomarker Candidates for Lewy Body Diseases (read here)
- Researchers find success with stem cell therapy in mice model of Alzheimer’s disease (read here)
- How do toxic proteins accumulate in Alzheimer’s and other diseases? (read here)
- Hypertension and Stroke as Mediators of Air Pollution Exposure and Incident Dementia (read here)
- New research reveals link between finger tapping and Alzheimer’s (read here)
- When Faced with Amyloidosis, Human Transplants Die by Necroptosis (read here)
- ‘A Profound Change’: New Guidelines Proposed for Diagnosing Alzheimer’s (read here)
- Mechanisms of phototherapy of Alzheimer’s disease during sleep and wakefulness: the role of the meningeal lymphatics (read here)
- Telecare Cuts Costs, Boosts Quality of Life for Dementia Patients (read here)
- Fundamental process behind memory now captured live (read here)
- Living in a disadvantaged neighborhood affects food choices, weight gain and the microstructure of the brain (read here)
- MEG3 activates necroptosis in human neuron xenografts modeling Alzheimer’s disease (read here)
- Evaluation of the Electronic Clinical Dementia Rating for Dementia Screening (read here)
- CSF Proteomic Panel Better Predicts Decline Than Do Classic AD Biomarkers (read here)
- Navigating the complexities of caregiving for dementia in South Asian communities (read here)
- Could a Breakdown in the Brain’s Networks Allow Infections to Contribute to Alzheimer’s Disease? (read here)
- New link between increased astrocytes in the brain and blood in early Alzheimer’s disease (read here)
- Researchers Create a New Window on Leading Genetic Cause of Alzheimer’s (read here)
- Large amounts of sedentary time linked with higher risk of dementia in older adults (read here)
- PLCγ2 Variants Toggle Microglial Plaque Compactors (read here)
- The High-Wire Act of Caregiving and Saving for Retirement (read here)
- Exercise-Induced Hormone Irisin May Reduce Alzheimer’s Disease Plaque and Tangle Pathology in the Brain (read here)
- Using Focused Ultrasound to Treat Alzheimer’s and Parkinson’s (read here)
- Specialized dementia care in nursing homes linked to better outcomes for residents (read here)
- Poor metabolic health could increase your risk of developing dementia later in life (read here)
- Some US airports strive to make flying more inclusive for those with dementia (read here)
- Health Care Costs Associated With Hospice Use For People With Dementia In The US (read here)
- The dementia tax (read here)
- Customize your dementia clinical trial recruitment materials with OutreachPro! (read here)
- ADscreen: A speech processing-based screening system for automatic identification of patients with Alzheimer’s disease and related dementia (read here)
- Hospital-Diagnosed Infections, Autoimmune Diseases, and Subsequent Dementia Incidence (read here)
- The Power of Food for People with Dementia (read here)
- New perspectives on understanding, preventing and treating vascular dementia (read here)
- Social isolation contributes to brain atrophy and cognitive decline in older adults, study suggests (read here)
- Emerging diagnostics and therapeutics for Alzheimer disease (read here)
- Treatments for AD: towards the right target at the right time (read here)
- Alzheimer’s Is a Terrible Disease—Especially If You’re Black (read here)
- UK researchers 1st to show multiple sclerosis drug can be used as Alzheimer’s therapy (read here)
- Unlocking how the new Alzheimer’s drug lecanemab works (read here)
August, 2023 News
CDC opens Health Brain Resource Center and repository of state and local AD/ADRD Plans
The Centers for Disease Control and Prevention (CDC) has opened its Healthy Brain Resource Center (HBRC), an easy-to-navigate website that helps users find credible public information and materials to support implementing the Healthy Brain Initiative (HBI) Road Map actions. CDC’s Alzheimer’s Disease Program also has compiled and centralized all publicly available state and jurisdiction strategic plans on Alzheimer’s disease and related dementias (ADRD). By having these plans easily accessible, states, jurisdictions, and other organizations interested in ADRD can learn what others are doing, which can foster collaboration and support engagement in priorities for action.
CDC announces new 43 BOLD capacity-building and implementation grant awardees
The Centers for Disease Control and Prevention (CDC) has announced 43 “BOLD Public Health Programs to Address Alzheimer’s Disease and Related Dementias” (CDC-RFA-DP23-0010) grant awardees. This funding is supported by the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act, Public Law 115-406. The award date is September 30. Recipients will use a public health approach to Alzheimer’s Disease and related dementias (ADRD) using CDC’s Healthy Brain Initiative State and Local Public Health Partnerships to Address Dementia: The 2023-2027 Road Map, the Road Map for Indian Country (RM Series), as well as future updates, as guides to expand and improve the response to ADRD in their jurisdictions.
Thirteen Component 1 recipients will be funded for two capacity-building years and three implementation years. During the capacity-building phase, recipients will be creating statewide dementia coalitions and developing or updating ADRD strategic plans for their jurisdictions. During the implementation phase, recipients conduct ADRD activities in line with their strategic plan and the Road Map actions. Thirty Component 2 recipients will be funded for five implementation years to conduct ADRD activities in line with their strategic plan and Road Map actions. All 43 recipients will increase awareness and understanding among the general public (including populations experiencing high burden), providers, and other professionals, about ADRD topics corresponding to primary, secondary, and tertiary prevention. Recipients will address the social determinants of health (SDOH) to achieve health equity goals including but not limited to the improvement of community-clinical linkages among health care systems and existing services, public health agencies, and community-based organizations. For the full list of recipients, along with additional project details as they become available, click here.
CMS announces GUIDE comprehensive dementia care model
On July 31, the Centers for Medicare & Medicaid Services (CMS) announced its Guiding an Improved Dementia Experience (GUIDE) Model — a package of care coordination and management, caregiver education and support, and respite services — which aims to improve the quality of life for people living with dementia, reduce strain on unpaid caregivers, and help people remain in their homes and communities. GUIDE will be tested nationwide from 2024-2032 as a voluntary alternative payment model (APM) through the CMS Center for Medicare and Medicaid Innovation (CMMI). Qualified participating health care providers will deliver comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. Under the GUIDE model, people with dementia and their caregivers will have access to a care navigator who will help them access services and supports, including clinical services and non-clinical services such as meals and transportation through community-based organizations. Prior to CMS releasing the application this autumn, interested organizations are encouraged to submit Letters of Intent to CMS by September 15. Providers eligible to be GUIDE participants are Medicare Part B-enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model. If an applicant cannot meet the GUIDE care delivery requirements alone, they may contract with another Medicare provider/supplier to meet the care delivery requirements. For additional information, see the GUIDE Model Fact Sheet , FAQ, press release, and sign up for the August 10 CMS GUIDE webinar.
CMS extends through September 2027 the Medicaid HCBS mandatory spousal impoverishment provisions
On August 15, the Centers for Medicare & Medicaid Services (CMS) released an informational bulletin notifying states that mandatory financial eligibility rules (spousal impoverishment provisions) for married applicants and beneficiaries eligible for home- and community-based services (HCBS) in Medicaid are extended to September 30, 2027. Under the Medicaid spousal impoverishment provisions, a certain amount of the couple’s combined resources is protected for the spouse living in the community. The extension helps married individuals seek coverage of certain long-term services and supports they need to stay healthy.
NIH releases FY 2025 Professional Judgement Budget and 2023 Scientific Progress Report
- Epidemiology/Population Studies
- Disease Mechanisms
- Diagnosis, Assessment, & Disease Monitoring
- Translational Research & Clinical Interventions
- Dementia Care & Impact of Disease
- Research Resources
ACL awards new Lifespan Respite Care Program grants
BOLD PHCOE Dementia Risk Reduction Summit recordings available
The Alzheimer’s Association BOLD Public Health Center of Excellence (PHCOE) on Dementia Risk Reduction recently held its Risk Reduction Summit at the Centers for Disease Control and Prevention (CDC). The Summit convened public health officials, researchers, and academics to identify what public health agencies at the state, local, and tribal levels can do to address dementia risk factors across the prevention spectrum. All sessions were recorded and now are available to view (YouTube). PDF presentations also are available. For additional information about the Summit or the PHCOE’s work, please contact centerofexcellence@alz.org.
Study defines disparities in memory care
NASEM publishes consensus framework on equity in health and medicine innovation
PCORI seeks applications for research on healthy aging
The Patient-Centered Outcomes Research Institute (PCORI) will open a funding opportunity entitled Healthy Aging: Optimizing Physical and Mental Functioning Across the Aging Continuum on September 6. PCORI will solicit applications for comparative clinical effectiveness research studies on different phases of the aging continuum that aim to achieve one or more of the following goals:
- Maintaining function and independence
- Facilitating chronic disease management
- Supporting individuals with significant functional impairment
- Reducing caregiving burden and improving quality of life
For this reissuance, PCORI especially encourages applications focused on improving the health care and health outcomes for older adults with multiple chronic conditions and those with sensory impairments such as loss of vision or hearing, as well as care models for individuals living with Alzheimer’s Disease and Related Dementias (ADRD). Applications of particular interest are those examining interventions that emphasize caregiver needs as well as those focusing on delivery models that integrate primary and specialty care as well as community-based services. PCORI further encourages applications focused on populations benefiting from a health equity approach, including those who are underserved, underrepresented or historically excluded.
Interested researchers should attend applicant webinar on September 13 and send a Letter of Intent by October 3 by 5 pm (ET). A total of $50 million in funding is available, with up to $12 million for each award.
CMS white paper assesses Innovation Center focus on health equity
Historically, Centers for Medicare & Medicaid Services (CMS) Innovation Center models were not designed explicitly to serve underserved populations, and most evaluations have not focused on health equity-related outcomes. In its 2021 strategy refresh, the Innovation Center prioritized health equity in all of its operations. To support the new goals, a retrospective analysis of model evaluations was conducted to determine the reach of Innovation Center models and assess the degree of and impact of health equity incorporation in model designs and evaluations. This analysis, “Assessing Equity to Drive Health Care Improvements: Learnings from the CMS Innovation Center,” identified means for evaluating health equity impacts and revealed gaps.
The review yielded three primary insights:
- The quality of the race/ethnicity variables in Medicare and Medicaid claims data presents a challenge for understanding whether models reach and enroll underserved individuals.
- Model designs have not always considered needs specific to underserved individuals.
- Model designs that do not prioritize the inclusion of underserved individuals may have small sample sizes for these populations that limits the ability to draw conclusions.
This study provides a foundation for assessing equity in prior health care models and for designing and promoting equitable quality improvement and evaluation.
Additional Reads
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- A review of the neurological imaging techniques in dementia diagnosis (read here)
- Deprescribing efforts failing dementia patients, study finds (read here)
- Dementia and Seizures: What’s the Relationship? (read here)
- LGBTQ+ caregivers of people with dementia face unique stresses that lead to poorer physical and mental health (read here)
- A fitness tracker for brain health: How a headband can identify early signs of Alzheimer’s disease in your sleep (read here)
- ‘Molecular road’ to Alzheimer’s leads to new treatment strategy (read here)
- Does microRNA-132 have therapeutic potential against Alzheimer’s disease? (read here)
- Intermittent Fasting Improves Alzheimer’s Pathology (read here)
- Melatonin and its Derivatives Enhance Long-Term Object Recognition Memory (read here)
- “Viral relicts” in the Genome Could Fuel Neurodegeneration (read here)
- Caution: Living Alone Puts People with Cognitive Decline at Risk (read here)
- Several vaccines associated with reduced risk of Alzheimer’s disease in adults 65 and older (read here)
- AI‐based assessments of speech and language impairments in dementia (read here)
- Long-Term Exposure to Air Pollution Increases Dementia Risk (read here)
- Restoring Helper Cell Function to Fight Alzheimer’s (read here)
- Price of elder care soars as demand increases, baby boomers age (read here)
- Disease severity and mortality in Alzheimer’s disease: an analysis using the U.S. National Alzheimer’s Coordinating Center Uniform Data Set (read here)
- Stanford Medicine-led research identifies gene ‘fingerprint’ for brain aging (read here)
- Opportunities For States To Promote Caregiver Integration For Hospitalized Patients (read here)
- Projected Savings to Canadian Provincial Budgets from Reduced Long-Term Care Home Utilization Due to a Disease-Modifying Alzheimer’s Treatment (read here)
- Does One Copy of the Christchurch ApoE Variant Slow Alzheimer’s? (read here)
- Study links changes in brain immune cells to Alzheimer’s (read here)
- Wanted: Fluid Biomarkers for CAA, ARIA (read here)
- Tau-PET: a window into the future of Alzheimer’s patients (read here)
- Stem Cell Therapy Rescues Symptoms of Alzheimer’s Disease (read here)
- Tiny Brains In a Dish Could Finally Uncover The Long-standing Mysteries of Psychedelics (read here)
- Alzheimer’s gene associated with increased fertility in Amazonian women (read here)
- Paying For Dementia Care That Improves Patient Outcomes, Supports Caregivers, And Saves Money (read here)
- Is ARIA an Inflammatory Reaction to Vascular Amyloid? (read here)
- Associations between air pollution and mental health service use in dementia: a retrospective cohort study (read here)
- Unraveling Alzheimer’s Catalysts as Weavers of Amyloid β Fibrils ~Molecular Mechanism of Accelerated Formation of Amyloid β Fibrils on Neuronal Cell Membranes (read here)
- Major US health systems expect to offer Alzheimer’s drug Leqembi in a few months (read here)
- Why consumer tests for risk of Alzheimer’s have potential downsides (read here)
- Researchers Propose a Data-driven Strategy to Stratify Risk of Progression from Mild Cognitive Impairment to Alzheimer’s disease (read here)
- Cohort LEADS Toward Better Understanding of Sporadic Early Onset AD (read here)
- The Healing Power of Art: Exploring its Therapeutic Benefits in Disease Treatment and Prevention (read here)
- Insulin-like hormones critical for brain plasticity (read here)
- Stress in childhood linked to physical and cognitive problems in older age, according to new study (read here)
- Increased Risk of Dementia Diagnosis, Benzodiazepine Exposure in Seniors with Anxiety (read here)
- Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution (read here)
- Former Sen. Max Baucus: Breakthrough Alzheimer’s drugs are out of reach for many in rural states like Montana (read here)
- The State of Artificial Intelligence and Machine Learning for Diagnosing, Differentiating and Predicting Prognosis in Dementia (read here)
- Diet Rich in Ultra-Processed Foods Can Accelerate Dementia Risk (read here)
- Novel vaccine key to reduce Alzheimer’s impact (read here)
- Minds & eyes: Study shows dementia more common in older adults with vision issues (read here)
- New policy research unit to improve dementia prevention, diagnosis and care (read here)
- Dementia care navigation: Building toward a common definition, key principles, and outcomes (read here)
- Estimating presymptomatic episodic memory impairment using simple hand movement tests: A cross‐sectional study of a large sample of older adults (read here)
- New Ultrasound Therapy Could Help Treat Alzheimer’s, Cancer (read here)
- TRIM11 protects against tauopathies and is down-regulated in Alzheimer’s disease (read here)
July, 2023 News
Senate HELP Committee reports out bipartisan pandemic prevention bill
On July 20, the Senate Health, Education, Labor, and Pensions (HELP) Committee, favorably reported out the bipartisan Pandemic and All-Hazards Preparedness and Response Act (PAHPA; S.2333, bill text with adopted amendments from Senator Hickenlooper and Senator Budd) on a 17-3 vote. PAHPA strengthens the nation’s biosecurity and biosafety, addresses the needs of at-risk populations, strengthens public health communications, coordinates research relating to long COVID, supports innovative technologies like wastewater surveillance, and reauthorizes the medical countermeasure priority review voucher program (see the legislation’s section-by-section details). Specifically, the Pandemics and All-hazards Preparedness and Response Act includes provisions to:
- Reauthorize core public health preparedness programs including the Public Health Emergency Preparedness cooperative agreements, the Hospital Preparedness Program, the Epidemiology Laboratory Capacity cooperative agreements, the Biomedical Advanced Research and Development Agency and the Strategic National Stockpile.
- Expand the representation of seniors and people with disabilities who advise the federal government on emergency preparedness.
- Require states to create crisis standards of care that prohibit discrimination of older adults and people with disabilities during disasters and emergencies.
- Promote better public health data-sharing during an outbreak.
- Establish a no-fault reporting system for laboratories to create a safety feedback loop.
- Support research and surge capacity during a pandemic.
- Support ongoing wastewater surveillance efforts.
- Examine the potential vulnerabilities to health security posed by artificial intelligence.
- Ensure that manufacturers communicate circumstances that may result in drug shortages and provide information to FDA in order to avoid potential shortages.
- Reauthorize the medical countermeasure priority review program.
Phase 3 confirmatory study shows donanemab significantly slows cognitive and functional decline early symptomatic Alzheimer’s disease
On July 17, Eli Lilly presented full results (see slides) from the Phase 3 TRAILBLAZER-ALZ 2 study (NCT04437511) showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease (either mild cognitive impairment or mild dementia). The data were shared at the 2023 Alzheimer’s Association International Conference (see the Alzheimer’s Association statement) and simultaneously published in the Journal of the American Medical Association (Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial). Lilly previously announced that donanemab met the primary and all cognitive and functional secondary endpoints in the Phase 3 study. Submission to the U.S. FDA for traditional approval was completed last quarter with regulatory action expected by the end of the year. Submissions to other global regulators are currently underway, and the majority will be completed by year end.
Participants in TRAILBLAZER-ALZ 2 were stratified by their level of tau, a predictive biomarker for disease progression, into either a low-medium tau group (sometimes referred to as intermediate tau) or a high tau group, which represented a later pathological stage of disease progression. All participants were then assessed over 18 months using scales that measure both cognition and function, including the integrated Alzheimer’s Disease Rating Scale (iADRS) and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). As previously reported, among participants with low-medium levels of tau (n=1182), donanemab treatment significantly slowed decline by 35% on iADRS and 36% on CDR-SB. Among all amyloid-positive early symptomatic AD study participants (n=1736), treatment with donanemab significantly slowed decline by 22% on iADRS and 29% on CDR-SB.
PCHETA reintroduced in Senate
Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) recently re-introduced the Palliative Care and Hospice Education and Training Act (PCHETA; S. 2243), bipartisan legislation to bolster the palliative care and hospice workforce and meet the growing need for care by investing in training, education, and research. Palliative and hospice care focus on relieving patients’ suffering from serious illnesses and working to improve their quality of life. Medical research shows that palliative and hospice care have been associated with enhanced quality of life for patients, reduced hospital expenditures and lengths of stay, and longer patient survival time. PCHETA would help ensure the necessary workforce to treat patients and improve the quality of life for millions of Americans facing serious illness by focusing on three key areas:
- Workforce Training – Supports the training of interdisciplinary health professionals, including physicians, nurses, social workers, physician assistants, chaplains, and others in palliative care; supports the training and retraining of faculty; and provides students with clinical training in appropriate sites of care.
- Education and Awareness – Shares research and information with patients, families, and health professionals about the benefits of palliative care and the services that are available to support patients with serious or life-threatening illnesses.
- Enhanced Research – Directs the Department of Health and Human Services (HHS) to use existing authorities and funds to expand palliative care research to advance clinical practice and improve care delivery for patients with a serious or life-threatening illness.
For additional information, read the PCHETA one-pager and the Palliative Care At-a-Glance factsheet.
RAISE Family Caregiving Advisory Council to start second term
The RAISE Family Caregiving Advisory Council — established by the Recognize, Assist, Include, Support, and Engage (RAISE) Family Caregivers Act — is charged with providing recommendations on effective models of family caregiving and support to family caregivers as well as improving coordination across federal government programs. On June 27, from 2:00 to 4:30 p.m. ET, the Administration for Community Living (ACL) will host a virtual joint meeting (public meeting access will begin at approximately 1:55 p.m. ET) to kick-off the new RAISE Family Caregiving Advisory Council and the Advisory Council to Support Grandparents Raising Grandchildren (SGRG). During the joint meeting, ACL will introduce and swear-in new council members for three-year terms. Additionally, federal leaders and partners will deliver presentations about the way forward for the work of the councils, and preview the next joint advisory council meeting (September 19). All information for the July 27 meeting, including an agenda, will be posted on the RAISE and SGRG webpages in advance of the meeting. Contact RAISE.mail@acl.hhs.gov with any questions.
FDA gives traditional approval to Leqembi, CMS offers broader coverage
On July 6, the U.S. Food and Drug Administration (FDA) converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. For details, read the full FDA statement and the full FDA-approved label, which contained a boxed warning. Please also read the full statement from Eisai and Biogen, which jointly developed Leqembi.
Immediately following FDA’s decision, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that it was broadening coverage for Leqembi. A CMS-facilitated registry is open for clinicians to access here. According to CMS
To receive Medicare coverage, people will need to: 1) be enrolled in Medicare, 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain, and 3) have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. Clinicians participating in the registry will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.
For additional information, read the full CMS statement along with the provider (download here) and consumer fact sheets (download here), and watch the short video demonstrating how health providers should enroll patients in the CMS registry.
The LEAD Coalition extends its gratitude to the FDA for its rigorous scientific examination of the evidence along with its careful consideration of stakeholder input, particularly regarding the necessity of addressing the high unmet need for treatments to slow the progression of Alzheimer’s disease. The LEAD Coalition commends CMS for listening and responding to the unified voice of the dementia advocacy community — including people facing Alzheimer’s disease, scientists and health care providers, LEAD Coalition member and allied organizations, bipartisan Members of Congress and state attorneys general, and others — by moving a great deal closer toward coverage-to-label over the past two years. The LEAD Coalition remains committed to working with CMS and other payers to lower and remove barriers to access for all FDA-approved treatments to prevent, slow, stop, or otherwise treat Alzheimer’s disease and other causes of dementia.
Treat and Reduce Obesity Act reintroduced
Senators Tom Carper (D-DE) and Bill Cassidy (R-LA) and Representatives Raul Ruiz (D-CA) and Brad Wenstrup (R-OH) have reintroduced the Treat and Reduce Obesity Act (TROA; bill text). According to the Centers for Disease Control and Prevention, diseases associated with obesity are the leading causes of preventable death in the U.S. The legislation would work to prevent these diseases through expanded coverage of new health care specialists and chronic weight management medications for Medicare beneficiaries. The bill also would work to mitigate the obesity epidemic by providing regular screenings.
Researchers publish first-ever county-level prevalence estimates for Alzheimer’s disease dementia
Rush University researchers have published the first-ever Alzheimer’s disease dementia prevalence estimates for each of the United States’ 3,142 counties. The study utilized cognitive data from the Chicago Health and Aging Project, a population-based study, and combined it with the National Center for Health Statistics 2020 bridged-race population estimates to determine the prevalence of Alzheimer’s disease in adults age 65 or older. The highest rates of prevalence were shown to occur in the East and Southeast US in states such as Maryland (12.9%), New York (12.7%), and Mississippi (12.5%). For counties with a population of 10,000 or more individuals age 65 or older, they estimate the highest Alzheimer’s prevalence rates were:
- Miami-Dade County, Fla. (16.6%)
Baltimore City, Md. (16.6%)
Bronx County, N.Y. (16.6%)
Prince George’s County, Md. (16.1%)
Hinds County, Miss. (15.5%)
Orleans Parish, La. (15.4%)
Dougherty County, Ga. (15.3%)
Orangeburg County, S.C. (15.2%)
Imperial County, Calif. (15.0%)
El Paso County, Texas (15.0%)
A combination of specific demographic characteristics may explain the higher prevalence in these counties, including older average age and higher percentages of Black and Hispanic residents. For example, among residents age 65 years and older of the Bronx County in New York, 14% were 85 and older (compared to a national average of 12% of people 65 and older), 30.1% were African Americans and 46.9% were Hispanic Americans (compared to national averages of 9.4% and 8.8%, respectively). The state- and county-specific estimates could help public health officials to understand the burden of disease (e.g., demand for caregiver counseling and institutional care) and develop strategies for identifying and caring for people with Alzheimer’s disease dementia. For additional details, see this interactive county-level map.
AARP’s GCBH issues recommendations for promoting brain health globally
AARP and the Global Council on Brain Health (GCBH) have released a report, “Building Better Brain Health for All People: GCBH Recommendations on Removing Barriers and Improving Opportunities Around the World,” which explores challenges to brain health faced by different communities around the world and offers recommendations to address such challenges. Within every country, public policies, political systems, economic conditions, social norms, and environmental factors influence health and wellness for better or worse. Discrimination based on age, race, ethnicity, gender and gender identity/roles, sexual orientation, national origin, caste, disabilities (visible as well as invisible), and genetic forms of neurological diseases contributes to poor physical and mental health in many societies. Barriers rooted in government policy, health care, institutional values, professional practice, and culture itself all may stand in the way of optimal brain health. To address these factors, the GCBH took a multifaceted approach, featuring nearly 40 recommendations, grounded in the latest scientific research and informed by the lived experience of individuals with cognitive loss. Innovations in policy, research, technology, community engagement, infrastructure, environmental design, and family supports are discussed in the report as parts of the answer.
Coalition launches action plans to improve nursing home quality
The national Moving Forward Nursing Home Quality Coalition recently released nine detailed action plans to improve the quality of life for residents and quality of work for staff in nursing homes. Each plan outlines specific steps to advance nursing home quality improvement:
- Creating care planning and measurement tools for residents’ goals, preferences & priorities
- Piloting best practices to strengthen nursing home resident councils
- Increasing CNA compensation through state quality incentive payment programs
- Developing a Certified Nursing Assistant (CNA) career pathway model using an established apprenticeship program framework to increase interest in the profession
- Creating a targeted recertification survey to improve overall state survey agency capacity
- Developing enhanced state surveyor trainings on person-centered care
- Increasing nursing home ownership data transparency
- Developing a health information technology guide to help nursing home operators navigate new regulations and digital capabilities
- Incentivizing converting traditional nursing homes with less privacy to smaller households with private rooms
Comprised of more than 120 individuals and organizations focused on nursing home reform, the Coalition launched in September 2022 to act on the National Academies of Sciences, Engineering, and Medicine report, The National Imperative to Improve Nursing Home Quality. The Coalition is funded by The John A. Hartford Foundation, and draws on leadership from LeadingAge, the Institute for Healthcare Improvement, other national organizations and advisors.
Additional Reads
- As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up (read here)
- Dementia becomes an emergency 1.4 million times a year (read here)
- Dementia Linked With Depression in Early and Middle Life (read here)
- Sleep Architecture, Obstructive Sleep Apnea, and Cognitive Function in Adults (read here)
- Oral Tau Inhibitor Continues to Show Promise in Alzheimer’s (read here)
- Mason research on supportive decision making could help people living with dementia (read here)
- Living in disadvantaged neighborhoods linked to higher dementia risk, study finds (read here)
- Detecting Alzheimer’s Disease: Older Adults’ Experiences with Cognitive Screening & Blood Biomarker Testing (read here)
- Intergenerational Trauma Among Elders (read here)
- Bodybuilding Supplement May Help Stave off Alzheimer’s (read here)
- These proteins could predict dementia risk decades before symptoms, new study suggests (read here)
- Lewy body disease can be detected before symptoms (read here)
- A New Way Of Diagnosing Alzheimer’s Disease Is On The Horizon (read here)
- Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial (read here)
- Promoting Healthy Aging: Public Health as a Leader for Reducing Dementia Risk (read here)
- New study shows anti-inflammatory drugs as a promising target for Alzheimer’s disease (read here)
- CRISPR/Gene Editing Technology Creates New Treatment Possibilities for Alzheimer’s Disease (read here)
- Lifestyle Enrichment in Later Life and Its Association With Dementia Risk (read here)
- Artificial intelligence tool that counts brain lesions in seconds (read here)
- A Novel Biosensor for Detecting Neurodegenerative Disease Proteins (read here)
- Biomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials (read here)
- Lecanemab to be Tested in Preclinical Alzheimer Disease (read here)
- Dementia Treatment: An Unmet Need (read here)
- The link between hearing loss and dementia (read here)
- Artificial Intelligence Is Everywhere You Look in Dementia Research (read here)
- This certification, developed with the Alzheimer’s Association, recognizes assisted living communities that use best practices for residents with dementia. (read here)
- Fast-spiking parvalbumin-positive interneurons in brain physiology and Alzheimer’s disease (read here)
- We finally have new Alzheimer’s drugs. How do we decide who gets them? (read here)
- A new era for Alzheimer’s treatment begins (read here)
- Taking good care of your teeth may be good for your brain, study suggests (read here)
- Fluctuating levels of cholesterol and triglycerides linked to increased risk of dementia (read here)
- Proteomics of brain, CSF, and plasma identifies molecular signatures for distinguishing sporadic and genetic Alzheimer’s disease (read here)
- Study suggests resistance training can prevent or delay Alzheimer’s disease (read here)
- Mortality and Discharge Location of Intensive Care Patients With Alzheimer Disease and Related Dementia (read here)
- Dementia is not the end of learning (read here)
- How a Swedish start-up reignited the search for an Alzheimer’s drug (read here)
- Repurposing Artificial Intelligence Tools for Disease Modeling: Case Study of Face Recognition Deficits in Neurodegenerative Diseases. (read here)
June, 2023 News
LEAD Coalition renews call for Congress to boost FY 2024 dementia funding
Healthy Brain Initiative releases new HBI Roadmap
On June 29, the fourth edition of the Healthy Brain Initiative (HBI) Road Map was released (see: full document and executive summary). “Healthy Brain Initiative: State and Local Road Map for Public Health, 2023-2027” provides public health officials nationwide with a set of strategies to promote brain health and improve the quality of life for people living with dementia and their caregivers. LEAD Coalition executive director Ian Kremer, along with representative of numerous LEAD Coalition member and allied organizations, served on the Leadership Committee to help develop this new edition of the HBI Road Map. The Alzheimer’s Association and the Centers for Disease Control and Prevention (CDC) jointly have led efforts to develop the evolving Healthy Brain Initiative Road Map Series for over 15 years.
- Strengthening partnerships and policies
- Measuring, evaluating, and utilizing data
- Building a diverse and skilled workforce
- Engaging and educating the public
Data and examples are included throughout to help state and local health departments achieve outcomes both individually and collectively. This Road Map advances equity by fully integrating brain health and caregiving into state and local public health practice and addressing social determinants of health that impact brain health across the life course. The Road Map provides public health practitioners with opportunities to reach diverse communities and reduce health disparities. For additional information, please attend the LEAD Coalition’s August 12 meeting, which will feature a guest presentation by the CDC and Alzheimer’s Association.
Roche’s tTau and Abeta42 Alzheimer’s assays receive FDA clearance
New report addresses healthy aging indicators
An analysis, “Indicators of Healthy Aging: A Guide to Explore Healthy Aging Data through Community Health Improvement,” conducted by the National Association of County and City Health Officials (NACCHO), found that most Community Health Improvement Plans (CHIPs) include priorities that, while not specifically addressing older adults, could be adapted for healthy aging programs. These priorities include chronic diseases, including heart disease, diabetes, stroke, and cancer, as well as substance use, depression, and other mental health conditions. To develop and strengthen age-friendly public health systems, a more comprehensive set of healthy aging indicators is needed to help health departments and community partners at the local, state, tribal, and territorial levels measure and identify population-level health disparities and inequities. Additionally, Community Health Improvement (CHI) partners need a robust, unified source of secondary data that aligns with healthy aging indicators to inform strategic and action planning.
This guide, developed by Trust for America’s Health and the National Association of County and City Health Officials (NACCHO) and with funding from The John A. Hartford Foundation, is designed to augment NACCHO’s Mobilizing for Action through Planning and Partnerships (MAPP) framework. MAPP is the most widely used CHI framework among governmental public health departments and, increasingly, community-based organizations, nonprofit hospital systems, and community health centers that lead or engage in CHI processes. This also serves as a resource for health departments seeking to attain Age-Friendly Public Health Systems (AFPHS) recognition.
Unanimous FDA advisory committee finds clinical benefit of lecanemab in treating Alzheimers disease
The Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) met on June 9 (FDA–2023–N–1114) to discuss supplemental biologics license application (sBLA) 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of early Alzheimer’s disease. This product was approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) for the treatment of Alzheimer’s disease. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The PCNS advisory committee discussed the confirmatory study, BAN2401–G000–301 (see: New England Journal of Medicine publication of Clarity AD study results), conducted to fulfill post-marketing requirement 4384–1 detailed in the January 6, 2023, approval letter. On the sole voting question, the PCNS advisory committee unanimously found that the Phase 3 Clarity AD study verified lecanemab’s clinical benefit.
For additional information, watch the recorded meeting webcast, review meeting background materials posted by the FDA, read the written public comments, and read the Eisai press statement. The PDUFA target action date for this sBLA is July 6.
LEAD Coalition urges CMS to adopt geriatrics quality measures
Over 240 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Centers for Medicare and Medicaid Services (CMS) expressing strong support for inclusion of the Geriatrics Hospital Measure and the Geriatrics Surgical Measure in the CMS Hospital Inpatient Quality Reporting (IQR) Program (proposed rule CMS-1785-P). Developed by the American College of Surgeons (ACS), the Institute for Healthcare Improvement (IHI), and the American College of Emergency Physicians (ACEP), these measures are designed to help build a better, safer, more age-friendly environment for geriatric hospital patients and will help patients and caregivers know where to get high-quality care that is in line with their values. These measures are a critical piece in optimizing care for older patients by using a holistic approach to create a quality program that better serves the needs of Medicare beneficiaries, especially those living with dementia. Read the full LEAD Coalition letter.
Expert panel calls for urgent policy changes to address inequitable access to Alzheimer’s drugs
An expert working group convened by the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and LuMind IDSC Foundation, has issued an advisory and consensus statement on criteria for access for adults with Down Syndrome (DS) to Alzheimer’s disease therapeutics (read the full report). The advisory follows a painstaking review of equity challenges faced by adults with DS with accessing the new class of anti-amyloid drug for mild cognitive impairment and early Alzheimer’s dementia. Adults with DS have an estimated lifetime risk of up to 90% for Alzheimer’s disease, which contributes to over 70% of their deaths. Adults with DS will face multiple years delayed access to these disease modifying treatments compared to other at-risk populations, because of exclusionary state prescribing authorization criteria (see table). Without urgency in altering these criteria, a generation of aging adults with DS potentially will be deprived of access to new treatments.
To shorten the time for access and to avoid delay in treatment, the working group recommends access through two actions: states and other payers should adopt the proposed DS-focused equivalency criteria as soon as possible, and Phase 4 clinical trials in adults with DS should be undertaken with similar urgency so that clinicians gain relevant information on the safety of this class of drugs for these atypical patients. The working group recommends a series of wording changes to reflect equivalencies in the prescribing criteria, offers substantiation for such changes, and calls upon relevant organizations to provide education to prescribers, and for professional associations to issue protocols for guiding prescribers in the use of this class of Alzheimer’s disease drugs.
Bipartisan legislation seeks to improve diversity in all NIH-funded trials
U.S. Senators Bob Menendez (D-N.J.) and Susan Collins (R-Maine), along with Representatives Robin Kelly (D-Ill.-02) and Brian Fitzpatrick (R-Pa.-01), recently introduced bipartisan, bicameral legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. The NIH Clinical Trial Diversity Act (S.1701/H.R.3503) builds upon the NIH’s current policies to enhance the inclusion of women, racially and ethnically diverse individuals and people of all ages in all NIH-funded trials. The NIH Clinical Trial Diversity Act would:
- Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan;
- Ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow ups, phone participation, weekend hours) to increase participation of underrepresented populations;
- Launch a public awareness campaign across federal agencies related to research participation opportunities.
President appoints Dr. Mandy Cohen as CDC Director
President Biden is appointing Dr. Mandy Cohen, an internal medicine physician, as Director of the Centers for Disease Control and Prevention (CDC). Under current law (which will change in 2025), the position does not require Senate confirmation. Dr. Cohen currently is Executive Vice President at Aledade and CEO of Aledade Care Solution, which helps independent primary care practices, health centers, and clinics deliver better care to their patients and thrive in value-based care. Previously, Dr. Cohen had served as Secretary of North Carolina’s Department of Health and Human Services. She also was Chief Operating Officer and Chief of Staff of the Centers for Medicare and Medicaid Services (CMS), and served as Acting-Director of the Center for Consumer Information and Insurance Oversight (CCIIO). Dr. Cohen was involved in many aspects of the Affordable Care Act policy development and implementation, including the expansion of coverage, insurance protections, and new provider payment models. A graduate of Cornell University, Dr. Cohen received her medical degree from Yale School of Medicine and a Master’s in Public Health from the Harvard School of Public Health. She trained in internal medicine at Massachusetts General Hospital. For analysis, click here.
LEAD Coalition joins wider health advocacy community in urging confirmation of NIH Director nominee
The LEAD Coalition joined 114 organizations in a letter to Senate leadership urging swift confirmation of President Biden’s nominee, Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH). Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Dr. Bertagnolli currently is Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director.
Issue brief proposes HCBS equity framework
In recent decades, long-term care has shifted from institutional settings to home and community-integrated settings. While access to home and community-based services (HCBS) has been increasing, systemic inequalities due to racism, sexism, ageism, classism, and other factors have led to large disparities in HCBS for diverse communities. Justice in Aging has published an issue brief, “An Equity Framework for Evaluating and Improving Medicaid Home and Community Based Services,” which evaluates ways the current organization of HCBS can contribute to inequities. The issue brief examines program design, provider availability, awareness of HCBS, implicit bias in services, and provision of HCBS. For each one of these domains, the issue brief provides case studies to help explain why the current policies lead to inequities. Additionally, the issue brief outline specific policies that should be reviewed in order to improve overall equity in HCBS programs.
Additional Reads
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- International Research Consortium Urges Scientists to Re-Think What Causes Alzheimer’s and Other Dementias (read here)
- Higher levels of lean muscle may protect against Alzheimer’s disease (read here)
- AI tool could speed up dementia diagnosis (read here)
- Menopausal hormone therapy and dementia: nationwide, nested case-control study (read here)
He Has Serious Dementia. Courts Are Still Waiting to Try Him for Murder. (read here)
Shorter Telomeres Point to Increased Alzheimer’s Risk (read here) - Understanding the value of secondary research data (read here)
- Changes in Human Microbiome Precede Alzheimer’s Cognitive Declines (read here)
- Blood condition linked to protection against Alzheimer’s (read here)
- Researchers show the importance of the liver-brain axis in Alzheimer’s disease (read here)
- Galectin-3 activates spinal microglia to induce inflammatory nociception in wild type but not in mice modelling Alzheimer’s disease (read here)
- Federal Data for Conducting Patient-centered Outcomes Research on Economic Outcomes (read here)
- A Closer Look at Hearing Loss, Dementia, and Stigma (read here)
- Abnormalities in neurodevelopment could lay the foundations for Alzheimer’s disease (read here)
- Ultra small molecule as a new target for Alzheimer’s disease? (read here)
- You’ll Soon Be Able to Get a Blood Test for Alzheimer’s (read here)
- VA researcher helping to change the future of Alzheimer’s Disease (read here)
- How Hospice Eligibility Criteria Can Adversely Affect Dementia Patients (read here)
- Altered gut bacteria may be early sign of Alzheimer’s disease (read here)
- Fluorogenic probe to detect enzyme linked to early stage of Alzheimer’s (read here)
- Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force (read here)
- AI helps show how the brain’s fluids flow (read here)
- Significant correlation found between vitreous human biomarkers and Alzheimer’s disease (read here)
- Brain waves may predict cognitive impairment in Parkinson’s disease (read here)
- Excessive alcohol consumption may accelerate Alzheimer’s disease progression (read here)
- UC Irvine neuroscientists develop ‘meta-cell’ to move Alzheimer’s fight forward (read here)
- Confronting aging: How LGBTQ+ seniors can tackle their special caregiving challenges (read here)
- Not covering emerging Alzheimer’s drugs could cost Medicare billions: study (read here)
- Dysesthesia and Depression in Undiagnosed Alzheimer’s Disease (read here)
- ArhGAP11A mediates amyloid-β generation and neuropathology in an Alzheimer’s disease-like mouse model (read here)
- Drawing, making music and writing poetry can support healing and bring more humanity to health care in US hospitals (read here)
- Supreme Court clears way for family of Medicaid recipient to sue state-owned nursing home (read here)
- Genetic protection from early-onset familial Alzheimer’s disease (read here)
- Researchers to Explore Potential of New Treatment Against Vascular Dementia (read here)
- Revealing How Blood Triggers Brain Disease (read here)
- Scientists Achieve Groundbreaking First by Applying Artificial Intelligence for Early Risk Forecasting of Alzheimer’s Disease (read here)
- A chance observation finds potential hearing biomarker for Alzheimer’s disease (read here)
- Improvement of retinal function in Alzheimer disease-associated retinopathy by dietary lysophosphatidylcholine-EPA/DHA (read here)
- Dementia Care Is Widespread In US Nursing Homes; Facilities With The Most Dementia Patients May Offer Better Care (read here)
- Improving the health and well-being of sexual and gender minority older adults (read here)
- The role of peripheral inflammatory insults in Alzheimer’s disease: a review and research roadmap (read here)
- Poorly insulated nerve cells promote Alzheimer’s disease in old age (read here)
- Alzheimer’s Disease Plasma Biomarker and Pathogenesis Contribute to Postoperative Delirium-like Behavior in Rodents (read here)
- Unweaving the microscopic threads of Alzheimer’s tapestry: single-cell dissection of vascular changes across six brain regions (read here)
- Being socially active in mid-late life linked to 30-50% lower dementia risk (read here)
- A Novel Blood Serum Assay to Diagnose Neurodegenerative Diseases (read here)
- Expanding Access to Alzheimer’s Care & Treatment (watch here)
May, 2023 News
President nominates Dr. Monica Bertagnolli as NIH Director
President Biden is nominating Dr. Monica Bertagnolli to serve as Director of the National Institutes of Health (NIH). Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. Dr. Bertagnolli currently is Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director. Previously, she served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. Dr. Bertagnolli is a member of the National Academy of Medicine, a past president and chair of the board of directors of the American Society of Clinical Oncology, and has served on the board of directors of the American Cancer Society and the Prevent Cancer Foundation. For analysis, click here.
FDA approves first treatment for agitation symptoms associated with dementia due to Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.
According to the FDA:
The recommended starting dosage for the treatment of agitation associated with dementia due to Alzheimer’s disease is 0.5 mg taken once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily. The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.
The most common side effects among patients with agitation associated with dementia due to Alzheimer’s disease include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (both somnolence and insomnia). Rexulti will retain the Boxed Warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The sNDA submission, from sponsors Otsuka and Lundbeck, was based on data generated from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with agitation associated with dementia due to Alzheimer’s disease. See the sponsors’ full press release here. Please read Full Prescribing Information, including Boxed Warning, and Medication Guide.
CMS updates nursing home visitation guidance for COVID-19
CMS releases 2023 SSI and spousal impoverishment standards
NIA launches updated AD/ADRD Research Implementation Milestones database
NIA has released an enhanced database for tracking of Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) Research Implementation Milestones. These milestones represent a research framework detailing specific steps and success criteria towards achieving the goal of the National Plan to Address Alzheimer’s Disease. Spanning basic, translational, clinical, and health services research, the 204 current milestones were developed based on recommendations from over 350 leading academic and industry experts, innovators and public advocates participating at strategic research planning summits. Users can browse the milestones by Research Areas and further refine by more targeted Research Implementation Areas. For each milestone, users will find success criteria and the projected timeline, along with updated information on progress and achievements, including funding initiatives, research programs and resources, and highlights.
NAPA advisory council examines pathways to new clinical treatments and comprehensive dementia care
New report addresses nursing home oversight
Phase 3 study top line results show donanemab significantly slows cognitive and functional decline
For additional information, see this AlzForum backgrounder on donanemab development, along with news coverage here and here.
Bipartisan group of 26 state attorneys general call on Medicare to cover new Alzheimer’s treatments
Led by Attorneys General Gentner Drummond (R-OK) and Keith Ellison (D-MN), a bipartisan group representing nearly half the states and territories have written to U.S. Health & Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging that “CMS provide full and unrestricted Medicare coverage for FDA-approved Alzheimer’s treatments consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries.” (Read the full letter.) The letter from these attorneys general comes amid mounting bipartisan efforts in the U.S. House and Senate to press CMS to reconsider its national coverage determination (NCD) for FDA-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N).
Additional Reads
- Understanding cognitive decline among elderly with Dementia using the “Heart-to-Brain Connection” (read here)
- Research reveals clues to why immune cells seem to cause brain damage (read here)
- Agitation in Alzheimer Dementia: Progress for an Age-Old Problem (read here)
- Human microglia show unique transcriptional changes in Alzheimer’s disease (read here)
- Does “Good” Cholesterol Increase Your Risk of Alzheimer’s? (read here)
- New information on the development of Alzheimer’s disease – Study reveals a possible cause of inflammation (read here)
- New UCI-led research shows people who live to be 90+ with superior thinking skills are resilient to Alzheimer’s pathology in their brains (read here)
- A lifetime of racism makes Alzheimer’s more prevalent in Black Americans (read here)
- UMD Study Finds Brain Connectivity, Memory Improves in Older Adults After Walking (read here)
- Exercise seems to protect against major brain hemorrhage (read here)
- Recurrent Brain Trauma May Increase Alzheimer’s Risk (read here)
- Association of BCG Vaccine Treatment With Death and Dementia in Patients With Non–Muscle-Invasive Bladder Cancer (read here)
- Time for Dementia: Quantitative evaluation of a dementia education programme for healthcare students (read here)
- Social participation and risk of developing dementia (read here)
- Study: Blood Vessel Damage Could Be an Alzheimer’s Driver (read here)
- 40 Hz vibrations reduce Alzheimer’s pathology, symptoms in mouse models (read here)
- Towards a future where Alzheimer’s disease pathology is stopped before the onset of dementia (read here)
- Study of mouse neurons uncovers novel therapeutic role of removing a genetic variant in the treatment of Alzheimer’s disease (read here)
- Equity across the life course matters for brain health (read here)
- Hi-Res Spatial Proteomics Uncovers Aspects of Alzheimer’s Disease Pathology (read here)
- Dementia study shows how toxic proteins spread (read here)
- Effects of physical exercise on physical function in older adults in residential care: a systematic review and network meta-analysis of randomised controlled trials (read here)
- Inhaling menthol improves cognitive function in Alzheimer’s disease (read here)
- The Mother Who Changed: A Story of Dementia (read here)
- NIH researchers identify large genetic changes that contribute to dementia risk (read here)
- A special omega-3 fatty acid lipid will change how we look at the developing and ageing brain, Duke-NUS researchers find (read here)
- Rochelle Walensky exits as CDC chief (read here)
- Association between chronic pain and risk of incident dementia: findings from a prospective cohort (read here)
- Passing the sniff test: Can we train our brain to boost smell and memory? (read here)
- Regular internet use may be linked to lower dementia risk in older adults, study says (read here)
- Deep sleep may mitigate Alzheimer’s memory loss, Berkeley research shows (read here)
- Dementia and self-harm: why it’s crucial to support patients in first year after diagnosis (read here)
- Prioritising dementia at the G7 (read here)
- Air Pollution May Increase Risk of Dementia, Complicated by Genetics (read here)
- Stress increases Alzheimer’s risk in female mice but not males (read here)
- Medicare’s ‘Coverage With Evidence Development’: A Barrier To Patient Access And Innovation (read here)
- Upregulation of extracellular proteins in a mouse model of Alzheimer’s disease (read here)
- Sleep deprivation exacerbates microglial reactivity and Aβ deposition in a TREM2-dependent manner in mice (read here)
- The structural and social determinants of Alzheimer’s disease related dementias (read here)
April, 2023 News
FDA advisory committee concludes that brexpiprazole for Alzheimer’s dementia agitation has a positive benefit-risk profile
On April 14, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee held a joint meeting to discuss supplemental new drug application (sNDA) 205422 s009, efficacy supplement for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceuticals and Lundbeck, for the proposed treatment of agitation associated with Alzheimer’s dementia (AAD). The joint advisory committee voted 9-1 that “the Applicant provided sufficient data to allow identification of a population in whom the benefits of treating agitation associated with Alzheimer’s dementia with brexpiprazole outweigh its risks” (view meeting materials and the archived meeting webcast). FDA has assigned the sNDA priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10.
Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (reported in approximately 45 percent of patients with Alzheimer’s dementia) and has a large impact on quality of life for the people living with AAD, family members, and caregivers. Agitation covers a large group of behaviors, and it is an excessive manifestation of “normal” human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting. Brexpiprazole, an antipsychotic medication approved in 2015 by the FDA as adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood. The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 (NCT01862640) demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213 (NCT03548584), treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
NIH seeks proposals for real-world data platform to advance dementia research
The National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) have issued a request for applications to develop the Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (RWDP). The NIA will fund a 6-year, up to US$300 million project to develop the RWDP, which will represent 70–90% of the US population (including up to 80% of people living with dementia). The RWDP will help researchers access and analyze health data in a secure cloud computing environment, and recruit from a more diverse pool of individuals. The RWDP also will support collaboration among health care and community health providers to develop and facilitate innovative methods for scalable digital, decentralized, pragmatic, and clinical trials. For additional perspective, read the NIA blog and click here.
Lecanemab OLE shows benefits even after treatment discontinuation
Recently published research has demonstrated that Alzheimer’s patients who take LEQEMBI™ (lecanemab-irmb) retain treatment benefits even after discontinuing the medication. The open label extension (OLE) study included 350 patients with mild to moderate Alzheimer’s disease who had taken LEQEMBI™ for a minimum of six months. The patients were divided into two groups; one group continued taking the drug, and the other group stopped. After six months, the discontinuation group showed no significant decline in cognitive function compared to the continuation group. Further research is needed to confirm these findings and to determine the optimal duration of treatment.
NAPA Dementia Nomenclature Initiative webpage launched
CMS issues 2024 Medicare Advantage and Part D Final Rule
CMS Medicare-Medicaid Coordination Office submits report to Congress
President issues executive order on caregiving
Non-drug Alzheimer’s interventions are effective and cost-effective
While new drugs to treat Alzheimer’s disease tend to receive the most public attention, many well-researched ways to care for people with dementia don’t involve medication. A new study by Brown University researchers compared the cost-effectiveness of four non-drug interventions to the usual care received by people with dementia and found that the care interventions resulted in a better quality of life and saved money. The study’s computer simulation model showed that the care interventions saved between $2,800 and $13,000 in societal costs, depending on the type of intervention, and all reduced nursing home admissions and improved quality of life compared to usual care. In addition to finding that the interventions were cost-effective from a societal perspective, the researchers found the interventions involved little to no additional cost for health care payers. Based on the study findings, the authors concluded that health insurance policies should find ways to incentivize providers and health systems to implement nonpharmacological interventions.
CVS Health to launch home-based care program for older adults
CVS Health has announced plans to improve home-based care for older adults who have been discharged from an acute care setting. The new post-acute care transition program will assign a caregiver to participants’ homes and provide them other necessary resources, such as reconciling medications with their primary care provider, ensuring that the home is age-friendly, offering home visits and helping arranging food and transportation services. For additional details, click here.
FasterCures report develops tool for more equitable clinical trials
Important safeguards have been implemented to protect research participants such as the National Research Act and the Belmont Report, but there remains a need for equitable participation and benefit for diverse populations in clinical research. A new FasterCures report, Mapping the Journey: Building a Mutual Understanding for Health Equity in Clinical Research, provides a tool for stakeholders involved in clinical research to establish a common language and basis for exchange and understand the differences among different types of trial sites. The report also details practical recommendations for achieving health equity at different types of trial sites and a visual illustration of how a patient might experience a typical clinical trial. FasterCures’ aim with this tool and its ongoing work to achieve health equity is to promote a more accessible, equitable research enterprise and drive meaningful multi-stakeholder engagement.
Additional Reads
- First ‘gene silencing’ drug for Alzheimer’s disease shows promise (read here)
- Demographic diversity of genetic databases used in Alzheimer’s disease research (read here)
- In Medicare Drug Price Negotiations, Avoid Metrics Steeped In Stigma (read here)
- Common Infections Linked to Poorer Cognitive Performance in Middle-Aged and Older Adults (read here)
- Depression and anxiety in people with cognitive impairment and dementia during the COVID-19 pandemic: Analysis of the English Longitudinal Study of Ageing (read here)
- Dementia-Related Medication Disparities Persist for Racial, Ethnic Minority Patients (read here)
- How Some Common Drugs Can Increase the Risk of Dementia (read here)
- The associations of socioeconomic status with incident dementia and Alzheimer’s disease are modified by leucocyte telomere length: a population-based cohort study (read here)
- How Donanemab Compares With Aducanumab in Amyloid Clearance (read here)
- Sleeping pill reduces levels of Alzheimer’s proteins (read here)
- Online tool found to be effective at assessing dementia risk (read here)
- Genetic testing for Alzheimer’s is on the rise. But what happens when the results are dire? (read here)
- The Home Care Workforce Has Not Kept Pace With Growth In Home And Community-Based Services (read here)
- The Office of New Drugs’ Efforts to Expand Regulatory Science Research (read here)
- New project to measure Alzheimer’s and Parkinson’s via the ear (read here)
- Astrocyte Dysfunction Causes Cognitive Decline (read here)
- Blood Tests May Help Physicians in Low-Resource Environments Diagnose Alzheimer Disease (read here)
- Blood-based biomarkers for Alzheimer’s disease could greatly simplify diagnosis and reduce costs (read here)
- What Happens After Amyloid Plaque Removal? Who Benefits Most? (read here)
- What Does Plaque Clearance Mean for the Long Haul? (read here)
- A new peptide may hold potential as an Alzheimer’s treatment (read here)
- A PREP inhibitor may help stop the progression of frontotemporal dementia (read here)
- AI can spot early signs of Alzheimer’s in speech patterns, study shows (read here)
- Screening for Delirium: What Clinicians Should Know (read here)
- People Living With Early Alzheimer’s Need President Biden’s Help (read here)
- Activation of hypothalamic-enhanced adult-born neurons restores cognitive and affective function in Alzheimer’s disease (read here)
- Half of carers for people with dementia struggling to make ends meet, study finds (read here)
- Scientists Enhance New Neurons to Restore Memory, Elevate Mood in Alzheimer’s Disease Research Model (read here)
- Air pollution may increase risk for dementia (read here)
- Phototherapy improves cognitive function in dementia: A systematic review and meta-analysis (read here)
- Conquering Alzheimer’s: a look at the therapies of the future (read here)
- Understanding factors influencing residential respite service use by carers of people living with dementia using Andersen’s behavioural model of health services use: A qualitative study (read here)
- Early menopause ‘may make women more likely to develop dementia’ (read here)
- How Can We Support Religious and Spiritual Practices of Older Adults With Mild Cognitive Impairment and #Dementia? (read here)
March, 2023 News
Breaking News: ADRD Therapeutics Work Group publishes Appropriate Use Recommendations for LEQEMBI™
On March 27, the Alzheimer’s Disease and Related Disorders Therapeutics Work Group (ADRD TWG) published its Appropriate Use Recommendations (AUR) for LEQEMBI™ (lecanemab-irmb). The abstract states:
Lecanemab (Leqembi®) is approved in the United States for the treatment of Alzheimer’s disease (AD) to be initiated in early AD (mild cognitive impairment [MCI] due to AD or mild AD dementia) with confirmed brain amyloid pathology. Appropriate Use Recommendations (AURs) are intended to help guide the introduction of new therapies into real-world clinical practice. Community dwelling patients with AD differ from those participating in clinical trials. Administration of lecanemab at clinical trial sites by individuals experienced with monoclonal antibody therapy also differs from the community clinic-based administration of lecanemab. These AURs use clinical trial data as well as research and care information regarding AD to help clinicians administer lecanemab with optimal safety and opportunity for effectiveness. Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Monitoring guidelines for these events are detailed in this AUR. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal. Microhemorrhages and rare macrohemorrhages may occur in patients receiving lecanemab. Anticoagulation increases the risk of hemorrhage, and the AUR recommends that patients requiring anticoagulants not receive lecanemab until more data regarding this interaction are available. Patients who are apolipoprotein E ε4 (APOE4) gene carriers, especially APOE4 homozygotes, are at higher risk for ARIA, and the AUR recommends APOE genotyping to better inform risk discussions with patients who are lecanemab candidates. Clinician and institutional preparedness are mandatory for use of lecanemab, and protocols for management of serious events should be developed and implemented. Communication between clinicians and therapy candidates or those on therapy is a key element of good clinical practice for the use of lecanemab. Patients and their care partners must understand the potential benefits, the potential harms, and the monitoring requirements for treatment with this agent. Culture-specific communication and building of trust between clinicians and patients are the foundation for successful use of lecanemab.
Administration releases FY 2024 budget proposal
Most administrations’ annual budget proposals are considered effectively “dead on arrival” by Congress, since Congress exerts control through the House and Senate Appropriations Committees. Especially in periods of divided government, this maxim tends to hold true. So while the FY 2024 Budget Proposal and the departmental Budget in Brief documents are important markers of what the Administration hopes its allies in Congress will support, they are unlikely to prove meaningful predictors of the funding levels that will be signed into law at the end of the FY 2024 congressional appropriations process.
Nonetheless, it is disappointing and troubling that the documents released on March 9 and March 13 fall far short of meeting urgent needs of the dementia community. For example, the proposal would increase overall NIH funding by only $920 million (far below the average annual increases in recent years) and shockingly would provide a paltry $16 million increase to the National Institute of Neurological Disorders and Stroke (NINDS) and provide no increase at all to the National Institute on Aging (NIA) — the two NIH institutes that are central to federal research on Alzheimer’s, FTD, LBD, VCID, and mix forms of dementia. Dementia research essentially would be flat-funded and, in fact, eroded by the effects of medical research inflation. This flies in the face of NIH’s own congressionally mandated, rigorous assessment of need articulated in the FY 2024 Professional Judgment Budget for Alzheimer’s Disease and Related Dementias. And while there are some laudable proposed increases in social safety net programs such as those at the Administration for Community Living, it is concerning that the Administration has proposed flat-funding for the Alzheimer’s Disease Program, Prevention of Elder Abuse and Neglect, and the Traumatic Brain Injury Program. For additional details, see the National Council On Aging (NCOA) table summarizing the Administration’s proposed 2024 funding for aging services programs.
LEAD Coalition member and allied organizations should remain optimistic in working with Congress and the Administration to take this starting point and refine it in the coming months to produce actual funding levels that better meet the urgent needs of the dementia community. Together, this stakeholder community can and must accelerate equity-centered and person-centered progress in risk reduction, detection and diagnosis, support to protect and promote quality of life for people with dementia and their care partners, and the pharmacologic and non-pharmacologic science to prevent, slow, stop and eventually end all forms of dementia.
Senators press HHS Secretary on CMS non-coverage of new Alzheimer’s treatments
CDC report examines racial and ethnic differences in subjective cognitive decline
VHA will provide veterans with broad coverage for LEQEMBI™
In a welcome break from the policy adopted by CMS, the U.S. Veterans’ Health Administration (VHA) is providing coverage for LEQEMBI™ (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease (AD). VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI™ to veterans who fit the VHA’s criteria and the U.S. Food and Drug Administration’s (FDA) current label. As Time Magazine reported, “The VA added Leqembi, which received accelerated approval from the Food and Drug Administration in January, to its list of nonformulary drugs. Patients who want to take the drug would have to request it and receive prior approval and meet stringent inclusion criteria, according to the VA website.”
LEQEMBI™: FDA priority review granted, July 6 PDUFA date set
The U.S. Food and Drug Administration (FDA) has accepted Eisai‘s supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI™ to a traditional approval. The LEQEMBI™ application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application, but has not publicly announced the date of the meeting. The sBLA is based on the findings from Eisai’s recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI™ met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
LEQEMBI™ was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI™ reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI™‘s clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. For additional details, see the full Eisai statement.
Roche and Lilly collaborating for early diagnosis of Alzheimer’s disease
Roche recently announced (see Reuters coverage) a new collaboration with Eli Lilly to support development of Roche’s Elecsys Amyloid Plasma Panel (EAPP). The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease. In July, Roche announced that the U.S. Food and Drug Administration granted the EAPP Breakthrough Device Designation. The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau181 occur in early stages of Alzheimer’s, while the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline. A two-year clinical trial is expected to involve several hundred study participants with early signs of dementia, and trial data may be available for an FDA regulatory filing as soon as 2025.
In December 2022, Roche also received FDA 510(k) clearance for its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays, which identify Alzheimer’s pathology in its early symptomatic stage.
Alzheimer’s Association publishes annual Facts and Figures report and special report on clinical conversations
On March 15, the Alzheimer’s Association released its 2023 Alzheimer’s Disease Facts and Figures report, providing an in-depth look at the latest national statistics on Alzheimer’s incidence, prevalence, mortality, costs of care, and impact on caregivers. The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression, and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available. For additional background, see the Alzheimer’s Association press release.
Dementia risk reduction infographic culturally tailored for AIAN communities
The International Association for Indigenous Aging (IA²) has adapted The Lancet Risk Factors for Dementia infographic and created a version, “Help Reduce Your Risks of Dementia,” culturally tailored toward American Indian and Alaska Native (AIAN) communities. The process of creating this infographic included talking circles with tribal community members, Dementia Friends & Champions, the University of Nevada, Reno Dementia Engagement, Education and Research (DEER) Program, IA²’s Brain Health Leadership team, and internal IA² staff members. This infographic is intended to be used within the Dementia Friends for American Indian and Alaska Native Information Session workbook.
NIH names new director for Tribal Health Research Office
Earlier this month, Lawrence Tabak, DDS, PhD, in performing the duties of the NIH director, announced that Karina Walters, PhD, MSW, will serve as the next director of the NIH Tribal Health Research Office (THRO). An enrolled member of the Choctaw Nation of Oklahoma, “Dr. Walters’ wealth of experience and deep commitment to engaging tribal leadership in health research efforts makes her ideally suited for the position,” Tabak said. “Her commitment to community-based participatory research is evident in her demonstrated ability to sustain collaborations with diverse Native communities and conduct successful randomized clinical trials in tribal communities,” he added. Walters succeeds David Wilson, PhD, who is on detail to the White House Council on Native American Affairs, and she will begin her new role as the THRO Director on April 24. For more information about Dr. Walters, click here.
NAC releases guide for patient advocacy groups to better support diverse family caregivers
The National Alliance for Caregiving (NAC) has released a new publication, Supporting Diverse Family Caregivers: A Guide for Patient Advocacy Groups, developed through research with professional patient advocacy group representatives and diverse family caregivers. The report addresses the impact of culture and identity on the way that family caregivers provide care, and introduces ways in which patient advocacy groups can support their caregiving experience through culturally responsive resources and supports. The number of diverse family caregivers in the United States is growing yearly, and their aggregate number will soon surpass non-Hispanic white, non-LGBTQ+ caregivers. According to Caregiving in the U.S. 2020, of the 53 million family caregivers in the United States, 17% identify as Hispanic/Latino, 14% identify as African American, 8% identify as LGBTQ+, and 5% identify as Asian American or Pacific Islander. The Centers for Disease Control and Prevention identifies one in every four American Indian or Alaska Native adults as family caregivers.
Additional Reads
- Alzheimer’s: New Study Supports Amyloid Hypothesis But Suggests Alternative Treatment (read here)
- Machine learning models rank predictive risks for Alzheimer’s disease (read here)
- In the whitewashed world of Alzheimer’s research, one scientist is on a quest to understand the diversity of brains (read here)
- Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds (read here)
- Getting to the root of Alzheimer’s disease (read here)
- Researchers propose a novel biomarker for early diagnosis of Alzheimer’s disease (read here)
- Individualized brain fingerprints can help to uncover early signs of Alzheimer’s disease (read here)
- Your Speech May Reveal Early Signs of Alzheimer’s (read here)
- Comparative Effectiveness and Safety of Oral Anticoagulants by Dementia Status in Older Patients With Atrial Fibrillation (read here)
- Food Insecurity and Cognitive Trajectories in Community-Dwelling Medicare Beneficiaries 65 Years and Older (read here)
- Gene therapy approach to boost ‘cold shock protein’ in the brain without cooling protects mice against neurodegenerative disease (read here)
- Why Alzheimer’s and Dementia Cause Mood Swings, and What to Do About Them (read here)
- Helping Older Adults Manage Alzheimer’s and Other Dementias (watch here)
- Are Hospitals Ready for Alzheimer’s Treatment Approval? (read here)
- Researchers identify new genes that modulate the toxicity of the protein β-amyloid, responsible for causing Alzheimer’s disease (read here)
- New Insights into Atypical Alzheimer’s Disease: From Clinical Phenotype to Biomarkers (read here)
- Blood Pressure Control May Help Mitigate Dementia Risk From Hypertension (read here)
- Promise of exosomal proteins as biomarkers in Alzheimer’s disease (watch here)
- Readmission Rates and Episode Costs for Alzheimer Disease (read here)
- Webinar: Alzheimer’s Treatment and Access (watch here)
- Masking a Splicing Site Compensates for TDP-43 Dysfunction (read here)
- Dementia, incontinence and the loss of dignity in acute hospitals (read here)
- Risk of death for people with dementia increases after a hurricane exposure (read here)
- Diabetes and Toothlessness Together Worsen Cognitive Decline (read here)
- Solving the Alzheimer’s Disease Puzzle: One Piece at a Time (read here)
- Lifetime discrimination linked to 40% higher risk of dementia, study finds (read here)
- Education and Dementia Incidence by Ethnicity and Nativity in Older Asian American Individuals (read here)
- Could Calming Overactive Ryanodine Receptor Restore Autophagy? (read here)
- Alzheimer’s Gene MS4A4A Governs the State of Microglia (read here)
- New Research Finds Antibody Detects Alzheimer’s Signals at Earliest Stages (read here)
- Do you already have Alzheimer’s? That’s what scientists at KU are asking young people (read here)
- Early diagnosis of Alzheimer’s disease (read here)
- Trouble falling asleep at bedtime or in the middle of the night? It could impact your risk for developing dementia (read here)
- No Country for Alzheimer’s Patients (read here)
- Those Declining Dementia Rates? It’s Not the Plaques and Tangles (read here)
- Black People Less Likely to Receive Dementia-Related Medications (read here)
- The Alzheimer’s Crisis in Indian Country (read here)
- Detecting mild cognitive impairment and dementia in older adults using naturalistic driving data and interaction-based classification from influence score (read here)
- Prevalence, Timing, and Network Localization of Emergent Visual Creativity in Frontotemporal Dementia (read here)
- Researchers identify three intestinal bacteria found in dementia with Lewy bodies (read here)
- Degrading modified proteins could treat Alzheimer’s, other ‘undruggable’ diseases (read here)
- Alzheimer’s and falls can be predicted using radar (read here)
- New Insights: Eye Damage in Alzheimer’s Disease Patients (read here)
- Why evenings can be harder on people with dementia—and how to cope (read here)
- Alzheimer’s Study Links Cholesterol And Toxic Protein Clusters (read here)
- Osteopontin may play key role in Alzheimer’s disease (read here)
- Distressing dreams in childhood and risk of cognitive impairment or Parkinson’s disease in adulthood: a national birth cohort study (read here)
- Vitamin D supplementation and incident dementia: Effects of sex, APOE, and baseline cognitive status (read here)
- Lilly Provides Update on A4 Study of Solanezumab for Preclinical Alzheimer’s Disease (read here)
- NIA statement on study results suggesting solanezumab does not reduce cognitive decline in people at risk for developing Alzheimer’s (read here)
- How Does Hospice Care Work? (read here)
- Study identifies four distinct pain trajectories in nursing home residents (read here)
- New AARP Report Finds Family Caregivers Provide $600 Billion in Unpaid Care Across the U.S. (read here)
- Senior care is crushingly expensive. Boomers aren’t ready. (read here)
- New report finds artificial intelligence fuels ageism in aged care (read here)
- DNA Treatment Could Delay Paralysis That Strikes Nearly All Patients with ALS (read here)
February, 2023 News
Breaking News: Director of FDA Office of Neuroscience announces retirement
Billy Dunn, M.D. is retiring from the U.S. Food and Drug Administration (FDA), where he has led the Office of Neuroscience (ON) in the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND). According to reporting in BioPharma Dive, Teresa Buracchio, M.D., an FDA veteran and currently the acting deputy director of the Office of Neuroscience, will take Dunn’s place on an acting basis.” The Office of Neuroscience consists of five review divisions: The Division of Neurology I, the Division of Neurology II, the Division of Psychiatry, the Division of Anesthesiology, Addiction Medicine, Pain Medicine, and the Division of Pharm/Tox for Neuroscience (DPT-N). The Immediate office oversees the development, review, and regulation of applications as well as issues related to toxicology for drug and biologic products reviewed in these divisions.
Dr. Dunn has served at FDA for over 17 years. Prior to joining FDA, Dr. Dunn served as a clinician and clinical researcher at the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). Dr. Dunn has served with distinction as a thoughtful leader and innovator, a determined regulator, and a powerful voice for addressing the high unmet needs of often marginalized people facing debilitating and life-threatening health conditions. The LEAD Coalition is deeply grateful for Dr. Dunn’s vision, leadership, and abiding commitment to improving quality of life for all who experience neurological disorders.
Check back here for updates on this breaking news.
FDA expects to complete reviews of brexpiprazole for Alzheimer’s dementia agitation by May 10
The U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (reported in approximately 45 percent of patients with Alzheimer’s dementia) and has a large impact on quality of life for the people living with AAD, family members, and caregivers. Agitation covers a large group of behaviors, and it is an excessive manifestation of “normal” human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting. Brexpiprazole (Rexulti), an antipsychotic medication approved in 2015 by the FDA as adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood.
FDA has assigned the sNDA priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10. The FDA also anticipates holding a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application, but a meeting date has not been set. According to brexpiprazole’s sponsors, Otsuka Pharmaceuticals and Lundbeck, the sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 (NCT01862640) demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213 (NCT03548584), treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).
CMS rejects request to reconsider its denial of coverage for FDA-approved Alzheimer’s disease treatments
On February 22, the Centers for Medicare & Medicaid Services (CMS) rejected (see: full CMS statement) a formal request to reconsider its national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N). As noted in the subsequent Alzheimer’s Association statement, CMS covers all FDA-approved drugs except for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. The American Academy of Neurology (AAN) also had formally requested (see AAN letter) that CMS initiate an expedited NCD reconsideration focused on lecanemab (LEQEMBI™) and based on the phase III data from the CLARITY AD trial published in the New England Journal of Medicine, which showed clinical meaningful benefits including slowing of cognitive dysfunction and a decrease in the decline of activities of daily living. AAN wrote, in part, “Throughout the National Coverage Analysis (NCA) and NCD processes, the AAN repeatedly raised concerns regarding the potential unintended consequences of applying this NCD to the entire class of mAbs for the treatment of Alzheimer’s disease. The AAN is concerned that absent a reconsideration of the NCD, patients who could benefit from lecanemab will be denied access, due to restrictions found in the NCD, leading to irreversible disease progression that could have been slowed with treatment.”
Video and materials now available from recent NAPA Advisory Council meeting
The Advisory Council on Alzheimer’s Research, Care, and Services held a virtual meeting on January 30 and 31. The Advisory Council received presentations on issues related to clinical practice and plans for advanced care planning, and reviewed the impact of new drug approvals and focus on risk reduction and social determinants of health. The National Institute of Neurological Disorders and Stroke (NINDS) presented on gaps and opportunities from the 2022 ADRD Summit, and other federal agencies will provided updates. Full meeting materials now are available, including video of all presentations, public comments, and Advisory Council discussions.
Report on CMS expanded use of Coverage with Evidence Development
The Alliance for Aging Research has published a new report, Façade of Evidence: How Medicare’s Coverage with Evidence Development Paradigm Rations Care and Exacerbates Inequity, which provides an overview of Coverage with Evidence Development (CED), CED’s deficiencies and harmful consequences, and how recent application of CED by the Centers for Medicare and Medicaid Services (CMS) set a dangerous precedent for future Medicare coverage. (An executive summary is available here.) According to the report, CMS increasingly is employing CED to restrict access to drugs, biologics, diagnostics, and medical devices approved by the FDA.
White paper examines urgency for Alzheimer’s policy solutions including innovation, treatment access, and caregiving
A new Alliance for Patient Access white paper, “Overburdened by Alzheimer’s: The Need for Care Innovation and Access,” highlights the disease’s burden and explores policies that could improve patient care. While no cure exists, treatment can slow Alzheimer’s disease progression and relieve patients’ symptoms. The paper identifies several policy solutions to help patients access innovative treatments and effective care:
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- Better coverage. Health plans can improve coverage for screenings, like PET scans and blood biomarker tests, to improve patients’ opportunities to benefit from a timely and accurate diagnosis.
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- Ongoing research. Funds can be invested for more research into disease-modifying therapies, and insurers can ensure such treatments are accessible to patients as they become available.
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- Caregiver support. Policymakers can collaborate to better support and resource caregivers.
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- Long-term care solutions. Policy solutions can make both at-home and residential care more accessible and affordable.
Hope for an Alzheimer’s cure remains. But in the meantime, the paper concludes, the nation can’t afford simply to wait.
Fact sheet explains how to protect dually eligible older adults when Medicaid public health emergency flexibilities end
Starting this Spring, millions of older adults who are dually eligible for Medicare and Medicaid will face redeterminations of their Medicaid eligibility, a process that had been suspended during the COVID-19 Public Health Emergency (PHE). Emergency flexibilities in delivery of Medicaid services also will begin to expire. This process will present significant challenges for states and for dually eligible for individuals who, compared to Medicare-only enrollees, have higher rates of disability and require more assistance with activities of daily living, experience higher rates of poverty leading to housing instability, and often need communication accommodations due to disability or limited English proficiency. A new Justice in Aging fact sheet, “Unwinding Medicaid Continuous Coverage Protections: Implications and Advocacy for Individuals Dually Eligible for Medicare and Medicaid,” provides information about the “unwinding” process and identifies steps that advocates can take with their states and partners to address the specific challenges facing dual eligible individuals during this transition.
In a related development, a new Kaiser Family Foundation issue brief, “Understanding the Role of Medicaid Managed Care Plans in Unwinding Pandemic-Era Continuous Enrollment: Perspectives from Safety-Net Plans,” shares how states can partner with Medicaid managed care organizations (MCOs) to prepare beneficiaries for the unwinding process. MCOs deliver care to more than two thirds of Medicaid beneficiaries.
Study finds correlation between care quality and online ratings for assisted living communities
A study recently published in the Journal of the American Geriatrics Society found that residents who live in assisted living communities with high online ratings spent more time at home—and less time in hospitals, nursing homes and other institutional settings—compared with those who live in assisted living communities that had no or low ratings. The study, which included 59,831 Medicare beneficiaries in 12,143 assisted living communities, was based on Google searches conducted on assisted living communities between 2013 and 2017 and linked to 2018–2019 Medicare data. Study authors observed that the absence of state or federal mandatory reporting requirements for assisted living communities, may leave customers to make decisions based on price and amenities rather than on vetted and comparative data regarding quality.
NTG issues advisory on over-medication of persons with intellectual disability
The National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and the Health Matters Program at the University of Illinois Chicago have issued a new advisory, “Over-Medication and Older Adults with Intellectual Disability: Risks for Brain Health,” which cautions users and families about several issues that arise from over-prescription and over-medication. The advisory offers suggestions for actions that primary care practitioners may undertake to review medications and their impact, as well as what families may do to become better informed and request medication reviews. The National Institute on Aging (NIA) and other organizations have noted that too often there is an accumulation of medications taken by older adults, and some of these medications may be no longer necessary or result in adverse effects. Studies show that many adults with intellectual disability are on numerous medications over their lifetime. Among older adults, some of these medications are still being taken even if unnecessary, others taken may cause behavioral problems or adverse health effects. Some taken for long periods may lead to cognitive problems and possibly dementia. The advisory notes a critical distinction between the use of ‘appropriate polypharmacy,’ which involves the prescribing of multiple medications that are clinically necessary and appropriate for the patient, and ‘inappropriate polypharmacy,’ which involves being prescribed many medications which if taken at the same time can be harmful if taken for too long, in an questionable dosage, and without considering drug interactions.
Additional Reads
- Predictors of cognitive functioning trajectories among older Americans: A new investigation covering 20 years of age- and non-age-related cognitive change (read here)
- Apathy as a Predictor of Conversion from Mild Cognitive Impairment to Alzheimer’s Disease: A Texas Alzheimer’s Research and Care Consortium (TARCC) Cohort-Based Analysis (read here)
- Machine Learning Selection of Most Predictive Brain Proteins Suggests Role of Sugar Metabolism in Alzheimer’s Disease (read here)
- Integrative in situ mapping of single-cell transcriptional states and tissue histopathology in a mouse model of Alzheimer’s disease (read here)
- When Perivascular Macrophages Spew SPP1, Microglia Eat Synapses (read here)
- Effect of long-term caloric restriction on DNA methylation measures of biological aging in healthy adults from the CALERIE trial (read here)
- Short-Term and Long-Term Sensitization Differentially Alters the Composition of an Anterograde Transport Complex in Aplysia (read here)
- Obesity-Associated Neurodegeneration Pattern Mimics Alzheimer’s Disease in an Observational Cohort Study (read here)
- Proton Pump Inhibitor Use and Risk of Dementia in Older Adults: A Systematic Review (read here)
- Costs During the Last Five Years of Life for Patients with Clinical and Pathological Confirmed Diagnosis of Lewy Body Dementia and Alzheimer’s Disease (read here)
- Dementia care programs help, if caregivers can find them (read here)
- No Easy Answers on Clinical Meaningfulness of Alzheimer’s Treatments (read here)
- Payment For Comprehensive Dementia Care: Five Key Recommendations (read here)
- Three New Prescription Drug Innovation Models Latest Action on Drug Pricing (read here)
- Risk of Discharge to Lower-Quality Nursing Homes Among Hospitalized Older Adults With Alzheimer Disease and Related Dementias (read here)
- Rethinking how we train caregivers for people with dementia (read here)
- More Pain, More Burdens: Researchers Find Link between Chronic Pain and Dementia (read here)
- Could Alzheimer’s be caused by an infection? (read here)
- Food insecurity may increase cognitive decline in older adults (read here)
- Research suggests link between low-quality education, dementia (read here)
- New research aims to understand why women more likely to develop Alzheimer’s disease (read here)
- Multi-country dementia study shows women’s greater risk may be linked to disadvantage (read here)
- Scientists find genetic Alzheimer’s risk factor tied to African ancestry (read here)
- Trans people more likely to have long-term conditions like dementia and autism, major study finds (read here)
- Senators call on Medicare to offer broad coverage of Alzheimer’s treatments as public pressure grows (read here)
- Study Suggests Fructose Could Drive Alzheimer’s Disease (read here)
- Updated: FDA adds warning of ‘larger areas of bleeding’ in brain to Biogen’s Aduhelm label (read here)
- Watch Your Step! Balance Ability Predicts Cognitive Impairment (read here)
- The ‘Tipping Point’ Toward Alzheimer’s (read here)
- Rethinking The Future Of Dementia Care (read here)
- Understanding the Link Between Personal Finances and Early Alzheimer’s (read here)
- Spending time in nature may protect against the risk of dementia (read here)
- California Dangles Bonuses for Nursing Homes That Add Staff (read here)
- New brain atlases and digital tools will make brain research more efficient (read here)
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