December, 2024 News

CR extends FY 2024 appropriations levels until March 14

President Biden has signed the American Relief Act, 2025 (H.R. 10515), a continuing resolution (CR), which extends funding at fiscal year (FY) 2024 levels for all 12 annual congressional appropriations bills until March 14. If a new CR or FY 2025 appropriations bills are not passed by Congress and signed into law by the new President by March 14, a partial or full federal government shutdown would result. The 119th Congress, which will convene on January 3, must act swiftly to address the LEAD Coalition FY 2025 appropriations priorities and reauthorize the Older Americans Act. 

HHS releases NAPA National Plan 2024 Update

The U.S. Department of Health and Human Services (HHS) has released the National Plan to Address Alzheimer’s Disease: 2024 Update, highlighting another historic year of progress on Alzheimer’s Disease and related dementia research, care, and services. The National Plan serves as a roadmap of strategies and actions of how HHS and its partners can accelerate innovate research and expansion of treatments, improve care, support for people living with dementia and their caregivers, and promote dementia risk reduction strategies. The 2024 National Plan updates includes a description of the accomplishments and activities undertaken from Fall 2023 through mid-2024, including new and ongoing action steps towards each of the Plan’s six top line goals. Notable highlights include the CMS Innovation Center’s launch of the GUIDE Model for coordinated dementia care, FDA’s approval of Kisunla (donanemab-azbt) to treat mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease, NIH-funded behavioral and lifestyle interventions research (e.g., blood pressure control, correcting hearing loss with hearing aids, daily, broad-spectrum multi-vitamin use, and personalized health coaching) that offer promise in reducing dementia risk and improving cognition and memory, and the development of new diagnostic tests for dementia. For a deeper review of the Plan Update, view the recording of the December LEAD Coalition meeting.

CMS updates nursing home surveyor guidance

The U.S. Centers for Medicare & Medicaid Services (CMS) has issued revised guidance (QSO-25-07-NH) for nursing home surveyors. The revised guidance includes updated procedures related to admissions, transfers and discharge of residents, resident assessment along with quality and life and quality of care, discouraging unnecessary use of psychotropic drugs and chemical restraints, definitions of levels of pain and pain management, Quality Assurance Performance Improvement (QAPI), infection prevention and control, administration and compliance related to the use of the Payroll-Based Journal for reporting of nurse staffing, and other topics. These revisions are designed to ensure that guidance remains aligned with current standards of practice and reflects the evolving needs of residents. Surveyors will begin using this guidance to determine compliance with requirements on surveys beginning February 24, 2025.

NASEM releases report on AD/ADRD research priorities

The National Academies of Science, Engineering, and Medicine (NASEM) has released its consensus study report “Research Priorities for Preventing and Treating Alzheimer’s Disease and Related Dementias.” Under the direction of Congress, this report was commissioned by the National Institute on Aging (NIA) and the National Institute on Neurological Disorders and Stroke (NINDS) to assess the current state of research on the prevention and treatment of Alzheimer’s disease (AD) and AD-related dementias (ADRD). The committee was tasked with developing a report to summarize its findings, conclusions, and recommendations on research priorities for preventing and treating AD/ADRD, as well as strategies for overcoming barriers that impede scientific advancement. The recommendations are meant to build upon (not supplant) National Institutes of Health (NIH) AD/ADRD summits and implementation efforts.

The report recommends collaborative, multidisciplinary research to cross existing silos at the National Institutes of Health (NIH) and shed light on multiple types of dementia, the integration of research on both pharmacological and non-pharmacological treatment approaches, and better coordination with other federal agencies who support related areas of research. The report concludes that accelerating progress in AD/ADRD prevention and treatment will require transformational change through greater support for innovation in NIH-supported research; incentives are needed to promote more disruptive research approaches that may lead to significant steps forward. The report identifies 11 research priorities and associated near- and medium-term scientific questions that should be a focus of NIH-funded AD/ADRD biomedical research, as well as nine complementary recommendations focused on overcoming crosscutting barriers to progress on the recommended research priorities. The priorities fall into three broad areas:

• Quantify brain health across the life course and accurately predict risk of, screen for, diagnose, and monitor AD/ADRD
• Build a more comprehensive and integrated understanding of the disease biology and mechanistic pathways that contribute to AD/ADRD development and resilience over the life course
• Catalyze advances in interventions for the prevention and treatment of AD/ADRD spanning from precision medicine to public health strategies

In addition to the full report, NASEM has prepared a study highlights summary and a  recommendations summary, and will hold a January 15 public webinar to discuss report findings and recommendations.

Alzheimer’s Association publishes new clinical practice guideline for diagnosing AD/ARRD 

An expert workgroup representing primary and specialty care has developed and published the new Alzheimer’s Association Clinical Practice Guideline for the Diagnostic Evaluation, Testing, Counseling and Disclosure of Suspected Alzheimer’s Disease and Related Disorders (DETeCD-ADRD CPG). The guideline summarizes the process of diagnostic evaluation and disclosure for persons suspected of potentially having cognitive-behavioral impairment due to Alzheimer’s disease (AD) or AD related disorders (ADRD) including Lewy Body Disease, Frontotemporal Lobar Degeneration, Vascular Cognitive Impairment and Dementia (VCID), and a host of other diseases and conditions that may cause or substantially contribute to cognitive-behavioral impairment. This guideline does not propose diagnostic or staging criteria for these diseases, criteria which continue to evolve.

According to the guideline, a comprehensive evaluation should include setting goals in partnership with the patient and usually a care partner, obtaining information about the patient’s risk profile for AD or ADRD (e.g., age, family history of dementia, hypertension, smoking), describing the history of symptoms and their impact on daily life, evaluating the patient’s ability to perform tests of thinking abilities, and obtaining a brain MRI or CT scan along with laboratory tests for conditions that may contribute to cognitive impairment. The integration of new brain scans, spinal fluid tests, or other specialized tests into this comprehensive evaluation will add critical value to the diagnostic formulation and care plan for persons in whom there is a clinical concern for AD or ADRD.

For additional details, see the executive summary of recommendations for primary care, the executive summary of recommendations for specialty care, and the article use of validated clinical assessment instruments.

CDC releases 2024 Healthy Brain Initiative Road Map for American Indian and Alaska Native Peoples

The 2024 Healthy Brain Initiative (HBI): Road Map for American Indian and Alaska Native Peoples offers actions to improve brain health throughout life and provides actionable steps for strengthening public health responses to Alzheimer’s disease and related causes of cognitive impairment and dementia in American Indian and Alaska Native (AI/AN)communities. The 2024 Road Map, developed with respect for tribal sovereignty and influenced by the traditions of the AI/AN peoples, promotes health equity by using a strength-based approach that honors the diverse AI/AN cultures. The 2024 Road Map reflects input from over 200 community members and professionals working in AI/AN communities and was guided by a Leadership Committee of tribal leaders, physicians, experts, and researchers in public health and across the care continuum. 

Building on the success of the first edition released in 2019, the updated 2024 Road Map focuses on the indigenous determinants of health, has inclusive imagery and graphics, and highlights examples of public health actions from AI/AN communities. The 2024 Road Map also incorporates the latest data, strategies, and culturally-centered approaches to promote brain health, address dementia-related challenges, and better meet the needs of caregivers. For additional perspective and information, see the executive summary, the “What’s New” overview, and the Healthy Brain Initiative (HBI) State and Local Road Map for Public Health, 2023—2027.

CDER establishes new Center for Real-World Evidence Innovation

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has established the new CDER Center for Real-World Evidence Innovation (CCRI) to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across CDER. RWD relates to a patient’s health status and/or the delivery of health care routinely collected from a variety of sources (e.g., electronic health records, medical claims, product and disease registries, and cutting-edge technologies). By using data from routine clinical practice, RWE can be generated that provides valuable insights into the safety and effectiveness of medical products. The volume and complexity of data available to support drug development have increased substantially over the past several decades. This increase—combined with enhanced computing power, emerging technologies, and advances in epidemiological and statistical methods—are transforming how drugs are developed, manufactured, and utilized. FDA views CCRI as a collaborative core for innovation and a focal point to ensure CDER promotes consistency and transparency on topics related to RWD and RWE. For additional information about CCRI and its work, review the FAQ and join the mailing list.

ADvancing States releases report on Medicaid waivers to assist older adults who do not have family caregivers

ADvancing States has released a report, “Advancing Equity for Older Adults without Family Caregivers: Trends in Medicaid Waivers,” to assist states designing and/or revising home and community based services (HCBS) waivers, The report analyzes how waiver language defines family caregivers and how those definitions relate to older adults without immediate family available as caregivers.

The number of older adults in the United States who need long-term services and supports (LTSS) is growing rapidly, with unpaid family care accounting for 65 percent of that care. However, one in seven older adults with significant needs for LTSS in 2020 did not have a spouse or children; by 2080, the proportion will be one in four. While some of the care for that population is projected to shift to paid care professionals, adults aging solo often turn to friends, neighbors and other members of their social networks to provide care. Medicaid provides states with a broad array of opportunities to deliver HCBS to help older adults and people with disabilities to live independently in their community using sections 1915(c) and 1115 of the Social Security Act. Many waivers incorporate provisions that recognize the importance of family caregivers in planning and providing those services. However, states vary widely in whether and how they define family in waivers, and those definitions may not reflect the needs and resources of adults aging solo and the friends and neighbors who look after them. 

Fellowship program launched to accelerate early detection of cognitive impairment

The Davos Alzheimer’s Collaborative (DAC), a pioneering worldwide initiative seeking to cure Alzheimer’s disease and improve brain health, has launch the U.S. Early Detection Fellowship Program to support health systems in implementing early detection of cognitive impairment and Alzheimer’s disease in primary care settings nationwide. As Americans have learned from their experience with cancer, detecting Alzheimer’s in a timely manner is important in extending quality of life and saving healthcare costs. Ten U.S. healthcare systems, representing a diverse cross-section of healthcare delivery models, geographic regions, and patient populations, have been selected to participate in this healthcare system fellowship program. Each site will receive seed funding to support the implementation of early detection programs, along with comprehensive coaching and technical assistance on program delivery from DAC experts based on the DAC Healthcare System Preparedness Early Detection Blueprint. The program will run through Q1 2026, with participants engaging in monthly virtual community of practice meetings to share learnings and identify and solve common operational barriers. Key objectives of the US Fellowship Program include: 

• Identifying and collaborating with 10 diverse health systems to create new early detection programs in primary care settings.
• Providing resources and catalytic assistance through targeted funding and support.
• Delivering DAC Early Detection Blueprint-based training.
  Evaluating and adapting the Blueprint to create a US-specific version for broader national implementation.

Additional Reads

November, 2024 News

Congress sends BOLD Infrastructure for Alzheimer’s Reauthorization Act to President Biden’s desk

The U.S. Senate unanimously passed the bipartisan BOLD Infrastructure for Alzheimer’s Reauthorization Act (S.3775 / H.R.7218), which reauthorizes the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act (P.L.115-406) and empowers public health departments to implement effective dementia interventions in their communities. The BOLD Reauthorization Act unanimously passed the House of Representatives in September, and now heads to President Biden’s desk to be signed into law. Since the original BOLD Infrastructure for Alzheimer’s Act passed in 2018, the Centers for Disease Control and Prevention (CDC) has made 66 awards to 45 state, local and tribal public health departments to help them implement effective dementia interventions such as reducing risk, increasing early detection and diagnosis, and supporting the needs of caregivers. For additional information, click here.

Nearly 400 organizations urge Congress to finalize FY 2025 funding increase for NIH

In a November 18 letter, nearly 400 organizations, including the LEAD Coalition, urged congressional appropriators to finalize the fiscal year (FY) 2025 Labor-HHS spending bill by the end of the calendar year with an increased investment in the NIH. Specifically, the letter urges that Congress provide no less than the Senate Appropriations Committee-approved level of $48.9 billion for NIH, in addition to funding for the Advanced Research Projects Agency for Health (ARPA-H). The letter noted that “Underinvesting in NIH’s annual base budget is to the detriment of patients today and tomorrow, undermines the future medical research workforce, and threatens to weaken U.S. competitiveness with global adversaries.” In related news, the House Labor-HHS Appropriations Subcommittee conducted a November 19 hearing on NIH with NIH Director Dr. Monica Bertagnolli. With the continuing resolution (CR) for FY 2024 set to expire on December 20, Congress has yet to finalize FY 2025 funding for federal agencies, and it is unclear whether Congress will pass a year-end spending package or use another CR to extend FY 2024 funding levels into a new Congressional session. 

EMA recommends Leqembi for treatment of early Alzheimer’s disease

After re-examining its initial opinion, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization to Leqembi (lecanemab) for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease in patients who have only one or no copy of ApoE4. The CHMP concluded that, in the restricted population assessed in the re-examination, benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks (provided that measures are in place to reduce the risk of severe and symptomatic ARIA and monitor its consequences in the long term). In July, the CHMP had issued a negative opinion on the use of Leqembi in a broader population of all patients with early Alzheimer’s disease. Leqembi will be available through a controlled access program to ensure that the medicine is only used in the recommended patient population.

Patients will need to have MRI scans to monitor for ARIA before initiation of treatment and before the 5th, 7th and 14th dose of Leqembi. Additional MRI scans may be needed at any time during treatment if patients develop symptoms of ARIA such as headache, confusion, visual changes, dizziness, nausea, and difficulty walking. To increase awareness of ARIA and ensure early detection and treatment, Eisai will provide a guide and checklist for healthcare professionals, an alert card for patients and training programs on ARIA for healthcare professionals. In addition, it must carry out a post-authorization safety study to further characterise ARIA-E and ARIA-H and assess the effectiveness of the risk minimization measures. The company will set up an EU-wide registry study with patients treated with Leqembi that can be used to estimate the incidence of side effects, including ARIA, and to determine severity. The registry study also can be used to collect information about patients’ progression to the next stages of Alzheimer’s disease and the possible long-term consequences of ARIA.

The CHMP’s opinion is an intermediary step on Leqembi’s path to patient access. The opinion will be sent to the European Commission for a decision on an EU-wide marketing authorization. Once a marketing authorization has been granted, decisions about pricing and reimbursement will take place at the level of each Member State, taking into account the potential role and use of this medicine in the context of its national health system.

FDA grants 510(k) clearance for AI-driven MRI to detect, diagnose, and monitor ARIA 

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for icobrain aria, an AI software for detecting, measuring, and grading amyloid-related imaging abnormalities (ARIA). A large study, needed for FDA clearance, demonstrated that the use of the software significantly increased the accuracy of ARIA assessments by radiologists, thereby allowing for safer use of new amyloid-beta targeting therapies for Alzheimer’s disease patients. The software works in the background and automatically generates an overview report on the ARIA assessment for radiologists using normal clinical MRI scans. For ARIA-edema (ARIA-E), the number of ARIA-E sites, their locations, and the longest axis of the largest site are measured and combined into an area severity score, graded according to clinical guidelines. For ARIA-hemorrhages (ARIA-H), the number of new microhemorrhages and areas of superficial siderosis are individually counted and localized, with an ARIA-H severity score reported, graded per clinical guidelines.

FDA updates Breakthrough Device designations data

The U.S. Food and Drug Administration (FDA) has updated the Breakthrough Device designations data, as well as the number of Breakthrough Devices that have received marketing authorizations. From the launch of the Breakthrough Devices Program through September 30, 2024, the FDA has granted 1,041 Breakthrough Device designations and authorized 128 Breakthrough Devices for marketing. The program is intended to provide patients and health care providers with timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Through the program, manufacturers can interact with the FDA’s experts to receive feedback on device development, receive help navigating the path to the FDA’s marketing authorization, and obtain prioritized review on regulatory submissions. 

CMS announces 2025 Medicare Physician Fee Schedule Final Rule

The U.S. Centers for Medicare & Medicaid Services (CMS) has announced the final rule on changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies, effective on or after January 1, 2025. In the rule, CMS finalized changes including:

• Decrease the PFS payment rates conversion factor for CY 2025 by 2.83 percent from the conversion factor for 2024.
• Establish new coding and payment for caregiver training for direct care services and supports, including techniques to prevent decubitus ulcer formation, wound care, and infection control. CMS will establish new coding and payment for caregiver behavior management and modification training that can be furnished to a patient’s caregiver(s).
• Add services to the Medicare Telehealth Services List, including caregiver training services on a provisional basis and PrEP counseling and safety planning interventions permanently, and other telehealth services.
• Create a new preventative care program, Advanced Primary Care Management (APCM), incorporating care management and telehealth services for ongoing primary care services. The APCM billing codes will be based on patient characteristics and resource intensity and will be divided into three levels: Level 1 for Medicare patients with one or fewer chronic conditions; Level 2 for patients with two or more chronic conditions; and Level 3 for patients with two or more chronic conditions who have QMB or Qualified Medicare Beneficiary Medicare Savings Program.

AoA release quality review toolkit for congregate nutrition programs

The Administration on Aging’s (AoA) Office of Nutrition and Health Promotion Programs has released the Quality Review Toolkit for Congregate Nutrition Programs. This four-part toolkit is designed for local service providers to self-assess their Title IIIC-1 program and supports alignment with the Older Americans Act requirements and helps identify opportunities for growth, innovation, and program enhancement.

DOJ reports on activities to combat elder fraud and abuse

The U.S. Department of Justice (DOJ) has released its sixth Annual Report to Congress on DOJ Activities to Combat Elder Fraud and Abuse. The DOJ has worked with local, state, Tribal, and federal partners to pursue over 300 elder justice enforcement actions against more than 700 defendants charged with stealing nearly $700 million from over 225,000 older victims. The DOJ has participated in nearly 1,000 public awareness events. The report includes resources, training, and tools available to law enforcement and other elder justice partners. In addition, the report highlights important information on trending fraud schemes and tips for how older adults and their families can protect themselves. 

Expert panel white paper: new Alzheimer’s disease treatments make early detection critical

The availability of amyloid-reducing therapies now makes detection of Alzheimer’s disease in its early stages critical, according to new expert-led Clinical Proceedings white paper from the Clinical Neurological Society of America. The paper, Alzheimer’s Disease: Understanding its Devastating Impact and Trend Toward Biological Diagnosis, is authored by five clinical neurologists and radiologist and calls for:

• Improving awareness of the burden of Alzheimer’s disease on patients, caregivers and the health care system;
• Reducing barriers to early diagnosis; and
• Increasing understanding of Alzheimer’s disease stages and the window for amyloid-reducing therapies.

The white paper also provides an overview of neuropsychological cognitive and functional assessment instruments, along with blood, imaging, and cerebrospinal fluid biomarkers to aid in the diagnostic process.  

Additional Reads

October, 2024 News

HHS OCR releases fact sheet on new Section 504 regulations

The U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has released a section-by-section fact sheet that provides a detailed overview of the new rule finalized in May. The fact sheet explains HHS’ implementing regulation for Section 504 of the Rehabilitation Act of 1973. The rule reviews issues including discrimination on the basis of disability in accessing medical care; value assessment methods used to determine whether a particular intervention will be provided; nondiscrimination in child welfare programs; information and communication technology; and providing services in an integrated setting appropriate to the person’s needs. 

CMS issues report on the Acute Hospital Care at Home Initiative

The Centers for Medicare & Medicaid Services (CMS) has issued report on the study of the Acute Hospital Care at Home (AHCAH) initiative, which allows certain Medicare-certified hospitals to treat patients with inpatient-level care at home. The study used the best-available quantitative and qualitative data on AHCAH, beginning with data collected in 2020, to draw comparisons between the AHCAH and brick-and-mortar hospital inpatient comparison groups. The study evaluated several aspects of the AHCAH initiative, including: 

• Criteria participating hospitals used to determine which individuals would qualify to receive services under AHCAH.
• Demographic information on beneficiaries treated under the initiative.
• Clinical conditions treated and diagnosis-related groups associated with discharges from the inpatient setting versus those under AHCAH.
• Quality of patient care for those patients treated in the brick-and-mortar inpatient setting relative to patients with similar conditions and characteristics treated under AHCAH. 
• Beneficiary and caregiver experience with AHCAH.
• Medicare spending and utilization for patients who received care in the inpatient setting and through AHCAH.
• Quantity, mix, and intensity of services furnished through brick-and-mortar inpatient care relative to those served under the AHCAH initiative.

For additional details, see the report fact sheet.

ACL launches National Caregiver Support Collaborative website 

The U.S. Administration for Community Living (ACL) has launched the National Caregiver Support Collaborative (NCSC) website, which will serve as a hub for all information about and from the collaborative as it works to achieve greater recognition, support, and inclusion of family, kinship, and tribal caregivers. The website will feature resources developed by each of the six NCSC projects, as well as materials produced by the technical assistance and coordinating center, such as caregiver assessments and best and promising practices in a range of topic areas. The site also will promote NCSC webinars, which are open to the public and designed for the aging and tribal services networks.

NIA publishes new cleared concepts for aging research

The National Institute on Aging (NIA) National Advisory Council on Aging (NACA) recently approved  new cleared concepts, which may become future initiatives published in the NIH Guide for Grants and Contracts. Among the newly cleared concepts are studies of dementia care and caregiver support interventions (Stage 1 only and Stages 2-5), a translational center for accelerating the use of digital technologies in Alzheimer’s disease and related dementias research, studies of aging in mammalian tissue, advancing aging research through Centers for Medicare & Medicaid Services (CMS) Data Linkage, and new institutional training programs for aging research. 

CMS issues memo on nursing home resident voting rights 

The Centers for Medicare & Medicaid Services (CMS) has released a memo reinforcing the regulatory expectations that Medicare and Medicaid-certified long-term care facilities affirm and support the right of residents to vote. The memo reminds states that nursing homes should have a plan to ensure residents can exercise their right to vote, whether in person, by mail, by absentee ballot, or through another authorized process. The memo includes information on how residents can report violations. Additionally, resources from the National Consumer Voice for Quality Long-Term Care and the National Ombudsman Resource Center provide information on long-term care residents voting rights. The Long-Term Care Resident’s Voter Guide provides tips on preparing to vote, being informed, and long-term care facility responsibilities for supporting residents voting. The Resident’s Right to Vote and Ombudsman Program Advocacy fact sheet shares ways Ombudsman programs support all residents’ right to vote and advocate on behalf of residents to ensure that they have the opportunity to participate in the electoral process.

NIH Scientific Management Review Board to meet following reestablishment

The National Institutes of Health (NIH) has announced the first meeting of the Scientific Management Review Board (SMRB) following its reestablishment earlier this year. The SMRB, established in 2006 by the NIH Reform Act (P.L. 109-482), is charged with formally reviewing and issuing recommendations on NIH’s organizational structure. The board’s membership is comprised of leaders in academia and directors of NIH Institutes and Centers and is chaired by Dr. Andrea Hayes Dixon, Dean of Howard University College of Medicine. On November 12, on the NIH campus, the SMRB will host a hybrid meeting that will be open to the public. The meeting agenda includes an overview of NIH’s mission, structure, and budget and summary of SMRB’s history and future direction. The draft meeting agenda and other information about the SMRB, including information about access to the webcast, will be available prior to the meeting at http://smrb.od.nih.gov. For additional information about the SMRB and its upcoming meeting, please contact Tyrone Spady, Ph.D., Acting Senior Advisor to the NIH Deputy Director.

Dr. Michelle Tarver named permanent director of the FDA’s Center for Devices and Radiological Health

The U.S. Food and Drug Administration (FDA) has announced that Michelle Tarver, M.D., Ph.D., has been selected as the permanent director of the FDA’s Center for Devices and Radiological Health (CDRH). Dr. Tarver is a board-certified ophthalmologist with a doctorate in epidemiology and has held various leadership positions at the FDA as a medical device regulator, helping drive strategic initiatives, conduct clinical research and changing organizational culture. Under her leadership, CDRH launched numerous efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the health care ecosystem and stimulate creative evidence generation pathways. 

AgeneBio’s Phase 2B trial shows AGB101 slows progression of brain atrophy in AD MCI patients who are non-carriers of the APoE-4 allele

AgeneBio, Inc. has published (“The HOPE4MCI study: AGB101 treatment slows progression of entorhinal cortex atrophy in APOE ε4 non‐carriers with mild cognitive impairment due to Alzheimer’s disease“) new findings from the HOPE4MCI Phase 2B study (NCT03486938) sharing promising results for Alzheimer’s patients who do not carry an ApoE-4 allele. The trial evaluated the efficacy of AGB101, a once-a-day investigational medication to treat amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD). Following the publication of the clinical-cognitive results showing a 40% reduction in progression over 18 months on the Clinical Dementia Rating (CDR) Scale published earlier this year, AgeneBio now has published the results of AGB101 treatment on biomarkers of AD in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Reported findings show that in ApoE-4 non-carriers, AGB101 matched the efficacy of FDA-approved biologics in clinical-cognitive progression in prodromal AD and surpassed any currently published data for AD therapeutics by significantly reducing atrophy of the entorhinal cortex, a key marker of disease progression in MCI due to AD. In addition, the reduction of brain tissue loss in treated participants was correlated with a reduction of blood-based biomarkers of neurodegeneration, further supporting a slowing of neurodegeneration in treated participants compared to controls. AgeneBio is completing an extension of this study (NCT05986721).

Additional Reads

September, 2024 News

Congress passes NAPA Reauthorization Act and Alzheimer’s Accountability and Investment Act

Congress has passed and sent to the White House for signature two critically important pieces of bi-partisan legislation to advance progress against Alzheimer’s disease and related forms of dementia. The NAPA Reauthorization Act (S. 133 / H.R. 619) reauthorizes the National Alzheimer’s Project Act (NAPA) through 2035 and modernizes the original 2011 legislation to reflect strides that have been made to understand dementia, such as including a new focus in the National Plan on promoting healthy aging and reducing risk factors. The Alzheimer’s Accountability and Investment Act (S. 134 / H.R. 620) will extend through 2035 a requirement that the Director of the National Institutes of Health submit an annual budget directly to Congress (a Professional Judgement Budget aka Bypass Budget) estimating the funding necessary for NIH to implement fully NAPA’s research goals. Only two other areas of biomedical research – cancer and HIV/AIDs – have been the subject of special budget development aimed at speeding discovery. Click here for additional information and advocacy resources. (Update: Both pieces of legislation were signed into law by President Biden on October 2. See the Alzheimer’s Association press release.)

ACL awards grants to advance dementia capability 

The U.S. Administration for Community Living (ACL) has issued new grant awards to two states and 11 communities for the 2024 Alzheimer’s Disease Programs Initiative (ADPI) – Grants to States and Communities program. The project period for these 13 grants is September 1, 2024, to August 31, 2027. The collective award amount is nearly $12.3 million. ACL’s ADPI program is dedicated to developing and expanding dementia capability in states and communities nationwide, including tribal communities. The three-year cooperative agreements will support and promote the development and expansion of dementia-capable home and community-based service systems that improve quality of life for people living with Alzheimer’s disease and related dementias (ADRD) and their caregivers. Grantees will dedicate efforts toward a broad range of people, including those with the most social and economic need, people with ADRD who live alone, those living with ADRD in tribal communities, people living with intellectual and developmental disabilities, and others who are at high risk of developing dementia, as well as services and trainings for paid and unpaid caregivers. Fifty percent of each grant will provide direct services that help individuals living with dementia and their caregivers remain independent and safe in their communities. To ensure program success, each new grantee will receive extensive technical assistance from the ACL-funded National Alzheimer’s and Dementia Resource Center.

IHS-led study examines disproportionate rates of younger onset dementia 

A new collaborative study from the Indian Health Service (IHS), Centers for Disease Control and Prevention (CDC), and the Alzheimer’s Association, “Alzheimer’s disease and related dementia diagnoses among American Indian and Alaska Native adults aged ≥45 years, Indian Health Service System, 2016–2020,” provides dementia estimates among American Indian and Alaska Native (AIAN) populations. This is the first study of Alzheimer’s disease and related disorders (ADRD) among Native populations who receive medical care at IHS, tribal, and urban Indian organization programs or through Purchased/Referred Care. The research found 14% of AIAN IHS patients seen during the study period had younger-onset dementia (between the ages of 45 and 64). This emphasizes the importance of clinicians discussing with their patients the signs and symptoms of dementia starting in middle age, and to ensure patients know memory loss or trouble with thinking that disrupts their daily lives is not a normal part of aging. The data provides a baseline to assess future progress for IHS and other efforts addressing ADRD in Native communities. For additional information, read the letter to IHS partners about the study findings and implications.

HHS issues National Strategy to Support Family Caregivers progress report

The U.S. Department of Health and Human Services has released a progress report on federal implementation of the 2022 National Strategy to Support Family Caregivers. The strategy presents a vision, establishes goals, and provides recommendations for ensuring that family caregivers have needed support and resources. The strategy also includes commitments from 15 federal agencies to nearly 350 actions to implement these recommendations. The progress report shows that nearly all these actions have been completed or are in progress (download the data tables zip file), and federal agencies have committed to almost 40 new actions since the strategy’s release Future reports and updates to the strategy will cover topics such as new and emerging policy considerations impacting family caregivers and the people they support, new recommendations for actions for all sectors to implement, and analysis of the impact of the strategy.

Elder Justice Innovation Grant awarded for adult protective services RISE model

The U.S. Administration for Community Living (ACL) has awarded a nearly $1.2 million Elder Justice Innovation Grant (EJIG) to the RISE Collaborative, Inc. for the first year of a three-year project. The EJIG program supports the continued development of evidence-based practices on elder abuse intervention and response. The project seeks to further validate the RISE model as an evidenced-based intervention embedded in Adult Protective Services (APS) programs. The model is rooted in four approaches:

• Repair Harm: Restorative justice approaches aim to reduce harm, promote healing, and help those involved in conflict work toward meaningful accountability and transformational change.
• Inspire Change: Motivational interviewing helps people feel that change is possible.
• Support Connection: Teaming is used to build more consistent formal (e.g., Meals on Wheels) and informal (e.g., neighbors) supportive networks around people in need.
• Empower Choice: Supported and interdependent decision-making assists people with cognitive impairment to achieve their goals.

The goal of the project is to better understand how the RISE model can be implemented across different contexts to increase its evidence base and improve outcomes for APS clients. Through rigorous intervention research, the project team will conduct site selection, adaptation, training, implementation, and evaluation of the RISE-APS model in diverse communities.

CMCS releases informational bulletin on continuity of coverage for individuals receiving HCBS

The Centers for Medicare & Medicaid Services (CMS) Center for Medicaid and CHIP Services (CMCS) has released an informational bulletin on ensuring continuity of coverage for individuals receiving home and community-based services (HCBS) through Medicaid. This bulletin outlines relevant federal Medicaid renewal requirements for individuals receiving HCBS and highlights an array of available strategies and approaches that states may implement to facilitate continued enrollment of eligible individuals. Strategies addressed in the bulletin include verifying income for non-Modified Adjusted Gross Income (MAGI) individuals using income from Supplemental Nutrition Assistance Program (SNAP) or Temporary Assistance for Needy Families (TANF) eligibility determinations, streamlining income determinations/renewing eligibility based on available data for income not likely to change, partnering with Managed Long-Term Services and Supports (MLTSS) plans to update beneficiary contact information, and partnering with local agencies to enhance “No Wrong Door” systems to assist individuals with maintaining Medicaid enrollment.

The loss of HCBS can pose a risk to beneficiaries’ health or result in institutionalization. In 2021, 86% of people who used Medicaid LTSS were exclusively served in home and community-based settings through 250 HCBS programs across 50 states. States have an ongoing obligation to conduct periodic renewals of eligibility in Medicaid consistent with federal regulations at 42 CFR §435.916 and to facilitate continued access to HCBS for those who remain eligible.

AHRQ issue brief addresses advancing diagnostic safety in older adults

A new Agency for Healthcare Research and Quality (AHRQ) issue brief highlights the unique patient, clinician, and systemic-related factors that impact diagnostic errors in older adults, with the objective of identifying opportunities for diagnostic improvement. The number of older Americans is projected to nearly double by 2060, with those aged 85 and older — many of whom have multiple chronic conditions and complex health and social needs, including cognitive impairment — expected to nearly quadruple between 2000-2040. The issue brief provides several recommendations for practice improvement, research, and policy to reduce older adults’ risk of diagnostic error. It also underscores the critical role of caregivers in the diagnostic process, recognizing the valuable insights they contribute. 

ADI releases World Alzheimer Report 2024

Alzheimer’s Disease International (ADI) has releases its World Alzheimer Report 2024, which offers a unique, global perspective on changing attitudes toward dementia, featuring a blend of essays, case studies, and research findings. The report also sheds light on how knowledge, perceptions, and behaviors towards dementia have changed over the past five years. The report delves into the results of an international survey analysed by the London School of Economics and Political Science (LSE), consisting of more than 40,000 responses from people living with dementia, carers, health and care practitioners, and the general public from over 166 countries and territories. The survey is a follow-up to ADI’s landmark 2019 Attitudes to dementia survey, and explores how perceptions of dementia have – or haven’t – changed in the span of five years. Key findings include: 

• 65% of health and care professionals incorrectly believe dementia is a normal part of aging. 
• 80% of the general public believe dementia is a normal part of aging, a dramatic increase compared to 66% in 2019. 
• 88% of people living with dementia indicate experiencing discrimination. 
• Over a quarter of people globally incorrectly believe there is nothing we can do to prevent dementia, with that number increasing from 20% in 2019 to  37% in lower- and middle-income countries. 
• More than 90% of carers and respondents from the general public said they would be encouraged to get a diagnosis if a disease-modifying treatment for dementia was available. 
• More than 80% of the general public believe that they can change the support provided to people with dementia through their vote. 
• Over 58% of the general public believe dementia is caused by an unhealthy lifestyle. 

NCOA map highlights benefit enrollment gaps among older adults

The National Council on Aging (NCOA) has released a new interactive map that indicates that, nationally, nine million adults aged 65 and over with limited incomes are eligible for but not enrolled in programs that can help them afford food, Medicare, and other daily expenses. The Benefits Participation Map, developed with the Urban Institute with funding from the U.S. Administration for Community Living (ACL), provides national, state, and sub-state level estimates of participation rates for adults 65 and older for three benefits programs: Supplemental Nutrition Assistance Program (SNAP), Supplemental Security Income (SSI), and Medicare Savings Programs (MSPs). The Benefits Participation Map is designed to help states and community-based organizations identify where to focus their enrollment efforts. 

NORC launches county-level dementia data portal

The National Opinion Research Center (NORC) at the University of Chicago, in collaboration with George Washington University’s Milken Institute School of Public Health and KPMG LLP, and with support from the National Institute on Aging, has developed an Alzheimer’s disease and related disorders (ADRD) surveillance system. The Dementia DataHub reports geographic counts of diagnosed ADRD prevalence, incidence, payments, mortality, and COVID-19 infection at the county, state, and national levels. The hub draws data from administrative health care data systems, including Medicare fee-for-service claims and Medicare Advantage encounter data, and presents it in interactive maps, dashboards, and public-use files. Future site updates will add additional years of data, data sources, and outcome measures.

NEHI report examines innovation in dementia detection

The Network for Excellence in Health Innovation (NEHI) has released a new report, “Detecting Dementia: Emerging Innovations and Their Implications for American Adults and Their Health Care,” examining new and emerging tests, tools, and protocols that could enable more nuanced and comprehensive dementia screening and brain health assessment. The report details actions needed to realize the benefits provided by the widespread deployment of these innovations. Under-detection and under-diagnosis of dementia result in a major gap in care for Medicare beneficiaries and exacerbates the long-term burden of Alzheimer’s disease and related disorders (ADRD) on patients, caregivers, and the Medicare program. Emerging tests, tools, and protocols are increasing the ability to screen and assess patients for ADRD and to perform assessments in primary care and other non-specialty settings. These innovations will be integral to the scale-up of dementia prevention, care, and treatment. Fully leveraging the potential of these innovations will require action in three primary areas: improving Medicare’s dementia and brain health assessment benefits to encourage broader uptake of cognitive assessments; elevating the priority of research focused on biomarker development and the application of innovative tests, tools, and protocols among research funders; addressing gaps in diagnostic and billing codes to facilitate the adoption of new tests and tools.

Additional Reads

August, 2024 News

LEAD Coalition submits comments on congressional proposal to reorganize NIH

The LEAD Coalition has submitted a letter in response to House Energy and Commerce Committee Chair Cathy McMorris Rodgers’ (R-WA) proposed framework of recommendations for reorganizing the National Institutes of Health (NIH). The LEAD Coalition letter encourages a congressional process that ensures Alzheimer’s disease and related disorders research continues to be addressed collaboratively across NIH with a life-course, person-centered approach. Read the letter here.

NIH releases FY 2026 Professional Judgement Budget and 2024 Scientific Progress Report

NIH also released its companion document, the 2024 NIH Scientific Progress Report, “Advances and Achievements,” which summarizes the achievements of the past year made possible through NIH-funded and -conducted research in nine broad areas:

• Advancing understanding of the risk and protective factors, genetics, and mechanisms of dementia
• Expanding large and complex datasets in accessible platforms to speed up translational research on therapeutic candidates
• Diversifying and de-risking the therapeutic pipeline for disease-modifying drugs
• Accelerating drug repurposing and combination therapy development
• Developing tools to detect, diagnose, and monitor dementia
• Advancing clinical research on lifestyle interventions
• Increasing understanding of how social and environmental factors affect dementia risk and disparities
• Expanding research on dementia care and care partner interventions
• Enhancing diversity and inclusion in clinical trials

FDA releases 2024 Language Access Plan

The U.S. Food and Drug Administration (FDA) has released its updated 2024 Language Access Plan, taking another key step toward addressing language barriers that impact health equity and strengthening language access to health information and services for the public, including people with Limited English Proficiency and people with disabilities. The plan also supports FDA efforts to identify interpretation language assistance, translate, and make important documents accessible, as well as digital and web content into multiple languages. The Language Access Program, led by the FDA’s Office of Minority Health and Health Equity (OMHHE), is a part of the FDA’s ongoing work to help individuals make informed decisions about their health.

CMS issues FY 2025 hospice payment rate final rule

The Centers for Medicare & Medicaid Services (CMS) has issued the final rule (CMS-1810-F) updating Medicare hospice payment rates and the aggregate cap amount for fiscal year (FY) 2025. The FY 2025 hospice payment update percentage is 2.9%, an estimated increase of $790 million in payments from FY 2024. The rule also clarifies current policy related to the hospice “election statement” and the “notice of election,” and adds clarifying language regarding hospice admission and certification of a terminal illness. For quality reporting, the rule:

• finalizes that Hospice Quality Reporting Program measures be collected through a new collection instrument, the Hospice Outcomes and Patient Evaluation (HOPE), and finalizes two HOPE-based measures;
• summarizes public comments received on potential social determinants of health elements;
• provides updates on health equity, future quality measures, and public reporting requirements; and,
• updates the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey.

For additional details, see the full CMS fact sheet.

ACL awards cooperative agreement for National Center on Elder Abuse

• Build increased knowledge and awareness of elder maltreatment and supportive resources.
• Foster stronger relationships with existing collaborators and new collaborations with organizations dedicated to the well-being of older people.
• Increase exposure to and understanding of elder maltreatment research and promising programs.
• Establish elder maltreatment champions in emerging professionals and under-utilized groups.
• Increase participation in a national annual World Elder Abuse Awareness Day campaign through events to spread awareness of elder abuse, neglect, and exploitation.

AHRQ releases strategic plan to advance older adult health 

The Agency for Healthcare Research and Quality (AHRQ) has released its “Strategic Plan for Health System Transformation to Optimize Health, Functional Status, and Well-being among Older Adults.” While the U.S. population is aging rapidly and the health system is ill prepared to meet the needs of older adults, much of the morbidity and premature mortality associated with aging can be delayed or slowed by re-engineering healthcare delivery systems in ways that improve health outcomes, functional status and well-being. In addition, chronic conditions can be effectively managed, allowing people to live independently and contribute to their communities longer. The AHRQ Plan includes more than two dozen strategies to advance the health and well-being of older adults.

AHRQ issue brief addresses test result electronic communication in the era of the Cures Act

A new Agency for Healthcare Research and Quality (AHRQ) issue brief identifies current evidence and best practices to inform patient-centered implementation of test result delivery though patient portals under the 21^st Century Cures Act. The Act removed most restrictions to patients’ access of their electronic health information. Healthcare organizations now routinely make test results available within patient portals when results are finalized. Information was solicited through a scoping review, along with a series of brief qualitative interviews with subject matter experts.

FDA announced the roster of the Digital Health Advisory Committee

The U.S. Food and Drug Administration (FDA) has announced the roster of the Digital Health Advisory Committee (DHAC) that will advise the FDA on issues related to digital health technologies (DHTs), providing relevant expertise and perspective to enhance the agency’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs. Additionally, on November 20-21, the FDA will hold the inaugural DHAC meeting in person with an available webcast. DHAC meeting topics include how the use of Generative AI may impact safety and effectiveness of medical devices enabled with this technology. Further details about this meeting will be announced in the Federal Register in accordance with the FDA’s policies and procedures for Advisory Committee Meetings.

Lancet Commission publishes 2024 update on dementia prevention, intervention, and care

According to the 2024 report of the Lancet Commission on dementia prevention, intervention, and care, an estimated 45% of cases of dementia potentially are preventable by addressing 14 modifiable risk factors at different stages during the life course. The 2024 Commission update also provides updates on advances in fluid biomarkers for detection of Alzheimer’s disease, new definitions for diagnosis of Alzheimer’s disease, as well as progress on disease-modifying treatments.

Even as people around the world live longer and the number of people with dementia is set to rise dramatically in all countries, the potential to prevent and better manage dementia is high if action is taken to tackle these risk factors, even in people with high genetic risk for dementia. Based on the latest available evidence, the new report adds two new risk factors that are associated with 9% of all dementia cases —with an estimated 7% of cases attributable to high low-density lipoprotein (LDL) or “bad” cholesterol in midlife from around age 40 years, and 2% of cases attributable to untreated vision loss in later life. These new risk factors are in addition to 12 risk factors previously identified by the Lancet Commission in 2020 (lower levels of education, hearing impairment, high blood pressure, smoking, obesity, depression, physical inactivity, diabetes, excessive alcohol consumption, traumatic brain injury, air pollution and social isolation), which are linked with 40% of all dementia cases.

To reduce dementia risk throughout life, the Commission outlines 13 recommendations to be adopted by governments and individuals, including:

• Provide all children with good quality education and be cognitively active in midlife.
• Make hearing aids available for all those with hearing loss and reduce harmful noise exposure.
• Detect and treat high LDL cholesterol in midlife from around age 40 years.
• Make screening and treatment for vision impairment accessible for all.
• Treat depression effectively.
• Wear helmets and head protection in contact sports and on bikes.
• Prioritise supportive community environments and housing to increase social contact.
• Reduce exposure to air pollution through strict clean air policies.
• Expand measures to reduce smoking, such as price control, raising the minimum age of purchase, and smoking bans.
• Reduce sugar and salt content in food sold in stores and restaurants.

The report notes that the prevention estimates assume a causal relationship between risk factors and dementia, and while the report only includes risk factors with convincing evidence, some associations may be partly causal. For example, while unremitting depression in midlife may be causal, depression in late life may be caused by dementia. Additionally, risk modification affects the population, and does not guarantee that any individual will avoid dementia.

ADvancing States issue brief addresses Adult Protective Services and self-neglect

ADvancing States has published findings on self-neglect from the 2022 national survey of Adult Protective Services (APS) Programs in the issue brief Self-Neglect: Findings from the ADvancing States National Survey of Adult Protective Services. 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. This brief focuses on the issue of self-neglect. While APS programs support clients experiencing many different types of maltreatment, clients experiencing self-neglect is the most prevalent form of maltreatment reported. The purpose of this brief is to describe the issue of self-neglect, discuss services needed for this population, and highlight what states are doing to address self-neglect. Findings from the full survey can be found in the report, Adult Protective Services in 2022: Responding to Evolving Needs in a Changing Environment.

LEAD Coalition welcomes new member organizations

The LEAD Coalition recently welcomed Brigade Health, PrognosUs, and Synthesys Brain Health as its newest member organizations.

Additional Reads

July, 2024 News

CMS Innovation Center launches GUIDE Model for coordinated dementia care and services

The Centers for Medicare & Medicaid Services (CMS) Innovation Center (CMMI) has launched the Guiding an Improved Dementia Experience (GUIDE) Model, with almost 400 participating organizations building Dementia Care Programs (DCPs) serving hundreds of thousands of Medicare beneficiaries nationwide. Through the GUIDE Model, CMS is testing an alternative payment for participants who deliver key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. Under the 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. The GUIDE Model 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. CMMI will evaluate the GUIDE Model’s impacts on the lives of people with dementia and their unpaid caregivers and evaluation results will inform any decision to expand the duration and scope of the GUIDE Model. 

On July 1, the 96 participating organizations in the Established Program Track began their participation in the GUIDE Model. These Established Program Track participants already have been providing most of the GUIDE care delivery services for over a year or more to people with dementia and their caregivers. CMS selected these participants for this track because they had a thorough plan in place to begin offering the full suite of GUIDE care delivery services beginning July 1, 2024. CMS assigned the other 294 participants, who need more time to fully develop and launch their DCPs, to the New Program Track and those organizations will begin offering GUIDE services on July 1, 2025.

GUIDE participants represent a wide range of health care providers, including large academic medical centers, small group practices, community-based organizations, health systems, hospice agencies, telehealth organizations, and other practices. GUIDE participants will serve diverse regions within each state; approximately 32% of DCPs will operate in rural or urban areas representing communities with low socio-economic status. The GUIDE Model is designed to encourage equitable care across all regions and racial and ethnic groups and includes several policies to ensure that underserved communities have equal access to the model’s enhanced dementia care delivery approaches, with the objective of reducing disparities in accessing high-quality services. This is critical to achieving the Innovation Center’s strategic objective to advance health equity.

For additional details, read the GUIDE Model launch blog, review the spreadsheet listing all GUIDE participants, and attend the August 14 LEAD Coalition virtual meeting that will feature a GUIDE Model presentation and Q&A session with CMMI. To request an invitation to the August 14 meeting, email LEAD Coalition executive director Ian Kremer.

FDA issues traditional approval to Kisunla for treatment of early symptomatic Alzheimer’s disease, Medicare announces coverage 

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) for the treatment of adults with early symptomatic Alzheimer’s disease, which includes people with mild cognitive impairment and those with mild dementia stage of AD. The recommended dosage is detailed in the prescribing information. As with previous treatments in this class, the FDA label requires confirmation of amyloid pathology. For additional details about Kisunla, please see the medication guide and coverage in Being Patient.

The Eli Lilly news statement noted that:

Patients’ out-of-pocket cost for treatment with Kisunla will depend on their length of treatment and their insurance. Coverage and reimbursement for Kisunla are now available for eligible patients on Medicare under a National Coverage Determination with Coverage with Evidence Development. Also, as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare. More than 98% of eligible Medicare patients have coverage that eliminates, limits, or caps their annual out-of-pocket exposure.

Additionally, Lilly Support Services for Kisunla (www.Kisunla.Lilly.com or 1-800-545-5979) is a free support program to help patients navigate treatment with Kisunla. The program includes coverage determination assistance, care coordination, nurse navigator support, and customized support and resources. The news statement also includes information about study data, clinical considerations for stopping treatment after sufficient amyloid clearance, and other topics.

The LEAD Coalition extends its gratitude to Eli Lilly, study participants and their partners, researchers, and the FDA for its rigorous scientific examination of the evidence along with its careful consideration of public comments. 

In a related development, the Centers for Medicare & Medicaid Services (CMS) announced Medicare coverage is now available for Kisunla, which joins Leqembi as the second monoclonal amyloid beta antibody treatment granted traditional FDA approval for Alzheimer’s disease. Medicare Part B covers the drugs with traditional FDA approval in this class when a prescribing clinician or their staff decides the Medicare coverage criteria are met and submits information to help answer treatment questions in a qualifying study. CMS posted updated fact sheets for providers and consumers about the CMS National Patient Registry for New Alzheimer’s Drugs.

FDA issues market clearance for NeuroLF ultra-compact PET imaging system

The U.S. Food and Drug Administration (FDA) has issued market clearance for the Positrigo dedicated brain PET system called NeuroLF^®, an ultra-compact innovative imaging device used to assists in diagnosing and monitoring brain related disorders including Alzheimer’s disease, tumors, epilepsy, and Parkinson’s disease. The NeuroLF system supports a paradigm shift in medical imaging where a dedicated device allows for imaging of a particular body part or organ. What is well established in cardiac imaging is just starting for the brain. The system requires minimal space and no special room modifications, allows patients to receive a brain scan in a seated position, and enables functional imaging at the point-of-care.

HRSA invests to address geriatric workforce needs

The Health Resources and Services Administration (HRSA) has announced more than $200 million to support 42 programs across the country aimed at improving care for older Americans, including those living iwth Alzheimer’s disease and related forms of dementia. HRSA’s Geriatrics Workforce Enhancement Program (GWEP) will train primary care physicians, nurse practitioners, and other health care clinicians to provide age-friendly and dementia-friendly care for older adults.  The program also focuses on providing families and other caregivers of older adults with the knowledge and skills to help them best support their loved ones.

CMS issues revised guidance on long-term care facility assessments

The Centers for Medicare & Medicaid Services (CMS) released revised guidance (QSO-24-13-NH) for State Survey Agencies on long-term care facility assessments. The guidance pertains to the recently released Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting final rule (89 FR 40876). The new requirements under §483.71, Facility Assessment, specify that the facility assessment must include an evaluation of diseases, conditions, physical or cognitive limitations of the resident population, acuity, and any other pertinent information about the resident population that may affect the services the facility must provide. The resident population assessment should drive staffing decisions and inform the facility about what skills and competencies staff must possess to deliver the necessary care required by the residents being served, as well as contribute to identifying the additional needs of residents. 

Alzheimer’s Association workgroup publishes biology-based criteria for Alzheimer’s disease diagnosis and staging 

The newly published “Revised Criteria for Diagnosis and Staging of Alzheimer’s Disease: Alzheimer’s Association Workgroup” define Alzheimer’s disease (AD) as a biological process that begins with the appearance of Alzheimer’s-related changes that happen in the brain before people exhibit memory and thinking problems. Progression, growth and expansion of these changes lead to the later appearance and progression of clinical symptoms, such as memory loss, disorientation, trouble with planning or organizing, and mental confusion. Symptoms and clinical syndromes commonly seen in people living with AD also may be caused by other disorders, so clinical presentation alone is not diagnostic of AD. The Revised Criteria are not intended to provide step-by-step clinical practice guidelines for clinicians or specific treatment protocols. Rather, they contain general principles to inform AD diagnosis and staging that reflect current science. The Alzheimer’s Association has initiated a collaboration with clinical and subject-matter experts, a variety of interested organizations, and patient representatives to develop guidelines for the clinical implementation of AD diagnosis and staging criteria. 

The Revised Criteria group biomarkers into three broad categories: core biomarkers of AD neuropathologic change (ADNPC), non-specific biomarkers that are important in AD but also are involved in other brain diseases, and biomarkers of diseases/conditions that commonly co-exist with AD. Core AD biomarkers have two subtypes:

• Core 1 biomarkers become abnormal early in the disease course. This category of biomarkers (either PET or biofluid) directly measures either amyloid plaques or phosphorylated tau. An individual with an abnormal Core 1 biomarker nearly always will have both plaques and tangles at autopsy in sufficient levels to meet standard criteria for AD diagnosis. Therefore, an abnormal Core 1 biomarker result is sufficient to establish AD diagnosis and contribute to clinical decision-making throughout the disease continuum.
• Later-changing Core 2 biomarkers reflect deposits of aggregated tau in the brain, and can provide prognostic information. When abnormal, they increase confidence that AD is contributing to symptoms.

The Revised Criteria consider the following to be Core 1 biomarkers: amyloid PET; CSF Aβ 42/40 ratio, CSF p-tau181/Aβ 42 ratio, CSF t-tau/Aβ 42 ratio; or accurate plasma assays, such as p-tau217. Core 2 biomarkers (biofluid and tau PET) have many uses but typically would not be used as standalone AD diagnostic tests.

Clinical study shows PrecivityAD2™ blood test improves Alzheimer’s diagnosis accuracy in primary care and specialist settings

The Journal of the American Medical Association (JAMA) has published results from a large clinical study examining the ability of C2N Diagnostics, LLC’s (C2N) PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease (AD) in primary care and specialist settings. The PrecivityAD2 test delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis. Specifically, the researchers found that the PrecivityAD2 test output (known as Amyloid Probability Score 2) demonstrated an accuracy at or above 90% for the total pooled cohort. Using a two cutoff-approach resulted in higher accuracies and positive predicate values of 97–99% in patients with cognitive impairment, meaning that a positive blood test result equated with actual presence of AD pathology. The results, involving over 1,200 patients, were substantiated despite a relatively high rate of co-occurring conditions such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and secondary care.

The PrecivityAD2 test involves a single blood draw sample and then uses high-resolution mass spectrometry to precisely measure proteins in the blood that indicate the likelihood of amyloid plaques in the brain, a pathological hallmark of AD. It relies on a rigorously-validated algorithm that combines plasma Aβ42/40 and p-tau217/np-tau217 (%p-tau217) ratios. The test provides clear answers with positive or negative results that reflect a high or low likelihood of the presence of brain amyloid pathology. The study outcome meets the Global CEO Initiative on Alzheimer’s Disease (CEOi) blood biomarker working group recommended performance criteria. The Precivity blood tests are intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.

NTG education initiative to boost inclusive health for adults with intellectual disabilities and dementia

The National Task Group on Intellectual Disabilities and Dementia Practices (NTG) has been awarded a grant from Special Olympics as part of its Inclusive Health Initiative. This grant will support a groundbreaking effort (“Changing Thinking!“), launching in September, to enhance the inclusion of adults with intellectual disabilities living with dementia, along with their caregivers, in the Centers for Medicare & Medicaid Services (CMS) new eight-year GUIDE Model. The NTG initiative will provide comprehensive education, information, technical assistance, and media resources to health care providers and care naviogators participating in the GUIDE Model. The goal is to ensure that adults with intellectual disabilities and dementia, who are Medicare eligible, receive the enhanced dementia support services and diagnostics they need while strengthening inclusive health systems capacity. For more information regarding the NTG Changing Thinking! project, contact Helen Stepowany, Project Manager. 

LEAD Coalition welcomes new member organizations

The LEAD Coalition recently welcomed Kernel and the Lewy Body Dementia Resource Center (LBDRC) as its newest member organizations.

Kernel is a precision neurotech company that is working to change the way the brain is measured, treated, and maintained. Kernel combines unique hardware capabilities with modern data science tools (AI & ML) to solve hard problems in mental health and neurodegeneration. Kernel has demonstrated early success identifying patients with mild cognitive impairment and is developing a tool to provide for fast and objective assessments of cognitive function as measured directly from the brain.

LBDRC is a 501(c)(3) nonprofit organization whose mission is to 1) raise crucially needed awareness of Lewy body dementia (LBD) through the dissemination of information to health care professionals and the general public; 2) offer loving support and services to LBD families nationally and internationally; and 3) promote essential scientific advances. LBDRC has the only live helpline for LBD in the U.S. and is available 365 days a year. Numerous support groups are offered via Zoom for people living with LBD and care partners. LBD Information is offered in Spanish, French, Hebrew, Chinese, Russian, Ukrainian, and Korean. LBDRC has an exclusive video series, Views From Within, which presents firsthand experiences of people living with LBD, their caregivers, and expert physicians in 10 short videos. A special program, Brian’s Buddies, dedicated to ending the social isolation of people living with LBD, connects individuals with others who have similar interests. LBDRC is the fiscal sponsor of the new documentary, Facing The Wind. LBDRC’s website has hundreds of resources to help find neurologists, therapists, meal deliveries, brain donation organizations, caregiving help, and much more.

PIPC releases resources for evaluating alternative measures for value assessment

The Partnership to Improve Patient Care (PIPC) has developed new resources about alternative methods and metrics for value assessment. It is widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to development of other measures and approaches that assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. To review the new resources, click here.

Additional Reads

June, 2024 News

FDA advisory committee votes unanimously in support of donanemab efficacy and benefit-risk analysis 

The U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee met to consider voting and discussion questions relating to Biologics License Application (BLA) 761248, for donanemab solution for intravenous infusion. The advisory committee  voted unanimously that donanemab is effective in meaningfully slowing disease progression and that its benefits outweigh risks. FDA is expected to issue its decision in the coming months. For additional information, watch the full meeting video, review the 40 written public comments (including the LEAD Coalition public comment signed by 265 organizations and researchers), and read news and analysis.

LEAD Coalition submits public comments for FDA review of donanemab

265 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Food and Drug Administration (FDA) regarding its review of the biologics license application for donanemab (BLA 761248) for the treatment of mild cognitive impairment and early dementia due to Alzheimer’s disease. The letter expresses full confidence in the FDA’s impartial, rigorous, and expert review based on the merits of the Phase 3 data. The letter also emphasizes the importance of treatments that delay progression to the next clinical stage of disease. 

LEAD Coalition and partners submit joint public comments to FDA on revised draft guidance for development of drugs to treat early Alzheimer’s disease

HHS releases strategic framework for national plan on aging

Performance recommendations for blood-based biomarker tests

NEHI roundtable examines pathways to MCI and early-stage dementia screening and detection

Atrial fibrillation associated with increase dementia risk

Physiological stress undermines cognitive reserve

Additional Reads

May, 2024 News

LEAD Coalition renews call for Congress to boost FY 2025 dementia funding

LEAD Coalition welcomes new member organization

The LEAD Coalition recently welcomed C₂N Diagnostics as its newest member organization. C₂N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C₂N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C₂N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C₂N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C₂N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. 

ACL issues final rule establishing APS regulations

The U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), has issued a final rule to establish the first federal regulations for Adult Protective Services (APS). The new regulations promote high quality APS and will improve consistency in services across states. With the final rule, ACL aims to support the national network that delivers APS, with the ultimate goal of better meeting the needs of adults who experience, or are at risk of, maltreatment and self-neglect.

• Establishes a set of national minimum standards for the operation of APS programs that all state APS systems must meet — and encourages states to exceed them.
• Requires APS systems to ensure that planning and delivery of all services respect the fundamental right of adults to make their own life choices and that services are driven by the person receiving them. 
• Establishes stronger protections for clients subject to, or at risk of, guardianship. 
• Requires response within 24 hours of screening to cases that are life-threatening or likely to cause irreparable harm or significant loss of income, assets, or resources.
• Requires APS to provide at least two ways — at least one online — to report maltreatment or self-neglect 24 hours per day, seven days per week. 
• Requires robust conflict of interest policies to support ethical APS practice.
• Establishes definitions for key APS terms to improve information sharing, data collection and program standardization. 
• Promotes coordination and collaboration with state Medicaid agencies, long-term care ombudsmen, tribal APS, law enforcement and other partners.

Legislation introduced to strengthen long-term care workforce

U.S. Senator Bob Casey (D-PA), Chairman of the U.S. Senate Special Committee on Aging, has introduced the Long Term Care Workforce Support Act (S.4120/H.R. 7994). The legislation would ensure caregiving can be a sustainable, lifelong career by providing substantial new funding to support workers in every part of the long-term care industry, from nursing homes to home-care to assisted living facilities. The bill comes as the United States faces a caregiving crisis marked by widespread worker shortages due to low pay and long hours across the essential industry. Specifically, the Long-Term Care Workforce Support Act will:

• Increase the number of direct care professionals, including in rural communities;
• Provide pathways to enter and be supported in the workforce for women, people of color, and people with disabilities;
• Improve compensation for direct care professionals to reduce vacancies and turnover;
• Ensure that the direct care professionals are treated with respect, provided with a safe working environment, protected from exploitation, and provided fair compensation;
• Improve access and quality of long-term care for families
• Document the need for long-term care, identify effective recruitment and training
  strategies, and promote practices that help retain direct care professionals.
• Strengthen the direct care professional workforce in order to support the 53,000,000 unpaid family caregivers who are providing complex services to their loved ones in the home and across long-term care settings.

The four million direct care professionals currently employed provide services to people living in their homes, in group homes, assisted living facilities, nursing homes, intermediate care facilities, and other long-term care settings. By 2031, an estimate9.3 million direct care professionals will be required to meet the caregiving demands of older adults and people with disabilities. According to a recent survey, 92% of nursing homes and nearly 70% of assisted living facilities reported significant or severe workforce shortages. In 2022, a survey of nursing homes showed more than 50% of the facilities were limiting the number of new admissions due to staffing vacancies or shortages. Another recent survey of home and community-based services (HCBS) providers showed all 50 states experiencing home care worker shortages, and 43 states reported that some HCBS providers have closed due to worker shortages. One in eight direct care professionals live in poverty, 75% earn less than the average living wage in their state, and 46% rely on public assistance, such as Medicaid, food assistance, or supplemental benefits. In addition to low wages, these workers report high levels of burnout and professional fatigue due to the daily physical and emotional demands of their jobs, lack of respect for the care that they provide, and health and emotional effects from battling the COVID-19 pandemic.

FDA issues final rule on laboratory developed tests

The U.S. Food and Drug Administration (FDA) has issued a final rule to help  ensure the safety and effectiveness of laboratory developed tests (LDTs), which are used in a growing number of health care decisions and about which concerns have been raised for many years. LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory that meets certain regulatory requirements. IVDs can play an important role in health care; they are used in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue. They can be used to measure or detect substances or analytes, such as proteins, glucose, cholesterol or DNA, to provide information about a patient’s health, including to identify, monitor or determine treatment for diseases and conditions. 

The final rule amends the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA issued a policy to phase out, over the course of four years, its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories. For additional details, click here.

HHS releases 2024 Medicare and Social Security Trustees Reports

The U.S. Department of Health and Human Services has released the 2024 Medicare Board of Trustees Report and the 2024 Social Security Board of Trustees Report. The report Medicare found that the Medicare Hospital Insurance Trust Fund, which pays for Part A benefits, will pay 100 percent of scheduled benefits until 2036, five years later than reported last year. In 2036, the fund’s reserves will pay 89 percent of costs. The Supplementary Medical Insurance (SMI) Trust Fund, which pays for Part B and Part D outpatient prescription drug benefits, is adequately financed into the indefinite future since its main financing sources – beneficiary premiums and the associated federal contributions from the Treasury – automatically are adjusted each year to cover costs for the upcoming year. In 2023, Medicare covered 66.7 million people and is expected to cover over 82 million in 2035. Additionally, the Social Security Administration Old-Age and Survivors Insurance (OASI) Trust Fund will be able to pay 100 percent of total scheduled benefits until 2033, unchanged from last year’s report, and the Disability Insurance (DI) Trust Fund is projected to be able to pay 100 percent of total scheduled benefits through at least 2098. For additional information, click here.

Socioeconomic status transition considerably extends years lived without dementia

According to a new study, Socioeconomic Status Transition Throughout Life and Risk of Dementia, upward social mobility may reduce risk for dementia. Research thus far has found correlations between socioeconomic status (SES) – parents’ assets, education level, income, and work status – and susceptibility to dementia, and SES changes throughout a person’s life, known as social mobility, seem to influence this risk; however, scientific evidences are lacking. The new study, led by Osaka University researchers, provides data-backed evidence that upward social mobility is associated with a lower dementia risk. Specifically, a downward SES transition was associated with the highest loss of healthy longevity from age 75 on. An upward SES transition was linked with the longest period of healthy longevity. The researchers used data from the Japan Gerontological Evaluation Study, which followed 9,186 participants aged 65 and over from 2010 to 2016. The study employed unsupervised clustering analysis and data-driven classification to analyze changes in participants’ SES throughout their lives. The analysis identified six distinct SES transition patterns. The researchers used a national registry of long-term nursing care services to determine dementia incidence, which enabled a detailed examination of the relationship between these transitions and dementia risk.

Subtle cognitive decline precedes end to driving for older adults

A new study, Predicting Driving Cessation Among Cognitively Normal Older Drivers, could provide guidance in helping older adults plan when to stop driving. The researchers found that impaired cognitive function foreshadows the decision for many seniors to stop driving, more so than age or molecular signs of Alzheimer’s disease. Even very slight cognitive changes are a sign that retirement from driving is imminent. Further, women are more likely to stop driving than men, the study showed. The findings suggest that routine cognitive testing — in particular, the kind of screening designed to pick up the earliest, most subtle decline — could help older adults and their physicians make decisions about driving to maximize safety while preserving independence as long as possible. 

Adults over age 65 are the most careful drivers on the road. They are less likely than drivers in any other age group to speed or to drive in bad weather, at night or under the influence of substances. Despite these precautions, age-related changes such as slower reaction time, impaired vision and cognitive decline still put older drivers at risk of crashes, and when such crashes happen, older drivers are more likely to be killed or seriously injured than younger drivers are. At the same time, giving up driving is not without its own risks. People who stop driving are more likely to develop depression and become isolated. 

• Investigating hyperactivation of memory circuits and Alzheimer’s disease risk (read here)
• Neurofilament Light Clears First Hurdle as Bona Fide FTD Biomarker (read here)
• Novel Dual-Language Touch-Screen Intervention to Slow Down Cognitive Decline in Older Adults: A Randomized Controlled Trial (read here)
• Altering Cellular Interactions Around Amyloid Plaques May Offer Novel Alzheimer’s Treatment Strategies (read here)
• Collaboration sheds light on enzyme linked to Alzheimer’s disease (read here)
• When dementia becomes too much to handle, this tool offers guidance (read here)
• Association between retinopathy and risk of dementia in a general Japanese population: the Hisayama Study (read here)
• Paid Caregiving in Dementia Care Over Time: Paid Caregiver, Family Caregiver, and Geriatrician Perspectives (read here)
• Intelligent prediction of Alzheimer’s disease via improved multifeature squeeze-and-excitation-dilated residual network (read here)
• Study defines major genetic form of Alzheimer’s disease (read here)
• Autopsies Confirm That PI-2620 Binds 4R Tau Deposits (read here)
• Tracking the cellular and genetic roots of neuropsychiatric disease (read here)
• Computational models may predict need for nursing care among older adults with dementia (read here)
• Clusters of cognitive performance predict long-term cognitive impairment in elderly patients with subjective memory complaints and healthy controls (read here)
• Combined use of Donepezil and Memantine increases the probability of five-year survival of Alzheimer’s disease patients (read here)
• Association of LIfestyle for BRAin health risk score (LIBRA) and genetic susceptibility with incident dementia and cognitive decline (read here)
• New weapon against dementia: “In just minutes, the AI solves a challenge that would take neuroscientists weeks.” (read here)
• Naturally occurring substance in pomegranates can improve treatment of Alzheimer’s disease (read here)
• Scripps Research scientists uncover new molecular drivers of Alzheimer’s (read here)
• Genetic Complexities of Cerebral Small Vessel Disease, Blood Pressure, and Dementia (read here)
• Novel Blood-Based Biomarkers and Disease Modifying Therapies for Alzheimer’s Disease. Are We Ready for the New Era? (read here)
• Scientists aim to stop harmful gut bacteria triggering Alzheimer’s (read here)
• Protective ApoE Variant Quells Interferon Responses in Tauopathy (read here)
• Analysis of gene expression in the postmortem brain of neurotypical Black Americans reveals contributions of genetic ancestry (read here)
• Intriguing connections between Alzheimer’s disease and other common conditions (read here)
• Creating Human Blood-Brain Barrier ‘Assembloids’ (read here)
• People with dementia aren’t currently eligible for voluntary assisted dying. Should they be? (read here)
• Using Clustering Methods to Map the Experience Profiles of Dementia Caregivers (read here)
• p75 neurotrophin receptor modulation in mild to moderate Alzheimer disease: a randomized, placebo-controlled phase 2a trial (read here)
• Gaining a Foothold: Amyloid Immunotherapy in Clinical Practice (read here)
• Welcoming the community into Alzheimer’s disease research studies (read here)
• Digital speech analysis may provide earlier warning of frontotemporal degeneration (read here)
• Climate change likely to aggravate brain conditions (read here)
• The Vicious Cycle of Protein Clumping in Alzheimer’s Disease and Normal Aging (read here)
• New gene delivery vehicle shows promise for human brain gene therapy (read here)
• Does a Rare Fibronectin Variant Protect Against APOE4? (read here)
• Love in a time of dementia: ‘A Song by Mahler’ combines science and music (read here)
• Reporting and representation of participant demographic information in completed Alzheimer’s disease clinical trials (read here)
• Alzheimer’s Disease Without Symptoms. How is That Possible? (read here)
• Older American Indians may experience higher levels of cognitive impairment than previously thought (read here)
• Blood Pressure Drugs More Than Double Bone-Fracture Risk in Nursing Home Patients (read here)
• New biomarker to diagnose Alzheimer’s in asymptomatic stages of the disease (read here)
• Research sheds light on how proteins linked to Alzheimer’s disease influence neuronal growth (read here)
• Study Explores Role of Epigenetics, Environment in Differing Alzheimer’s Risk Between Black and White Communities (read here)
• Study Reveals Racial Disparities in Diagnosis and Drug Use for Dementia Symptoms (read here)
• Innovative USask ‘mini-brains’ could revolutionize Alzheimer’s treatment (read here)
• ‘MUSIC Map’ Reveals Some Brain Cells Age Faster and Are More Prevalent in Alzheimer’s (read here)
• Over 20,000 people join search for new dementia treatments (read here)
• Black Adults at Risk for Alzheimer’s Disease Live in More Polluted Areas, U.S. Study Finds (read here)
• Does music unlock memory? (read here)
• UC Irvine-led study links sleep apnea severity during REM stage to verbal memory decline (read here)
• Judges and physicians have very different views about appointing a legal guardian for people with dementia (read here)
• USC researcher discovers drug that may delay onset of Alzheimer’s and Parkinson’s disease, and treat hydrocephalus (read here)
• Scientists find sleep may not clear brain toxins (read here)
• Peripheral GFAP and NfL as early biomarkers for dementia: longitudinal insights from the UK Biobank (read here)
• Nonpharmacological intervention therapies for dementia: potential break-even intervention price and savings for selected risk factors in the European healthcare system (read here)
• Effects of SPI1-mediated transcriptome remodeling on Alzheimer’s disease-related phenotypes in mouse models of Aβ amyloidosis (read here)
• Racial/Ethnic Disparities in Hospital Readmission and Frequent Hospitalizations Among Medicare Beneficiaries with Alzheimer’s Disease and Related Dementia: Traditional Medicare vs. Medicare Advantage (read here)
• Plasma biomarkers increase diagnostic confidence in patients with Alzheimer’s disease or frontotemporal lobar degeneration (read here)
• USTC Reveals Key Role of Glutamate tRNA Fragments in Brain Aging and Alzheimer (read here)
• Racial disparities in dementia treatment are killing Black and Asian people who die earlier as symptoms are missed and diagnosis comes too late.  (read here)
• Extreme behavioural and psychological symptoms of dementia: a case study (read here)
• Does Assisted Living Provide Assistance And Promote Living?  (read here
• Beyond Microglia—Alzheimer’s Gene PLCγ2 Acts on Synapses, Too (read here)
• Socioeconomic Status of Neighborhood May Impact Residents’ Dementia Risk (read here)
• Brain scans helped spot hidden forms of dementia in people with Alzheimer’s (read here)
• Diabetes in Youth May Increase Risk for Alzheimer’s, Other Diseases (read here)
• Poor-Quality Daily Social Encounters, Daily Stress, and Subjective Cognitive Decline among Older Adults (read here)
• Associations of hospital-treated infections with subsequent dementia: nationwide 30-year analysis (read here)
• Hospital-Based Health Professionals’ Perceptions of Frailty in Older People (read here)
• Medical Costs and Caregiver Burden of Delivering Disease-Modifying Alzheimer’s Treatments with Different Duration and Route of Administration (read here)
• APOE4 homozygozity represents a distinct genetic form of Alzheimer’s disease (read here)
• ADHD Tied to Risk for Lewy Body Disease, Dementia, MCI  (read here)
• Terminal lucidity: why do loved ones with dementia sometimes ‘come back’ before death? (read here)
• Do you really want to find out if you’ll get Alzheimer’s? (read here)
• I created a dementia-friendly forest trail in memory of my wife (read here)
• One woman’s journey with Alzheimer’s: How DU’s former chancellor is determined to delay the symptoms (read here)
• Personalized whole-brain neural mass models reveal combined Aβ and tau hyperexcitable influences in Alzheimer’s disease (read here)
• The Unequal Burden of Early Dementia on Black Americans and How We Can Change It (read here)
• Resident-to-resident aggression common in assisted living (read here)
• To treat Alzheimer’s, first we must diagnose it (read here)
• Association between Cardiometabolic Risk and Cognitive Function among Older Americans and Chinese (read here)
• Nutrient research reveals pathway for treating brain disorders (read here)
• Increased staffing may only be part of improved care for nursing home residents with dementia (read here)
• Dementia prevention: from idealism to realism (read here) 
• Preventing and Treating Alzheimer’s Disease and Related Dementias: Promising Research and Opportunities to Accelerate Progress  (read here)
• Engaging Native Hawaiian Communities in Clinical Trials (read here)
• Banking behaviour could be used to detect early Alzheimer’s, finds new research (read here)
• Organ transplant drug may slow Alzheimer’s disease progression (read here)
• After an Alzheimer’s Diagnosis, Helping Others Became Her Elixir (read here)

April, 2024 News

Dr. Jeffrey Cummings has published his annual Alzheimer’s drug development pipeline report, which categorizes 164 active trials and 127 unique treatments, representing an approximately 10% decrease from the 2023 report’s findings. The decline was attributed in part to inadequate funding from both government and private sectors, along with persistent challenges in  trial recruitment. Among the 127 treatments:

• 76% are disease-modifying treatments (DMT) that aim to slow the decline of memory; of these 96 DMT, 53 (55%) are small molecules and 43 (45%) are biologics
• 34% are biological therapies given intravenously or through some other injection
• 12% are cognitive enhancing agents that are intended to improve memory
• 13% are drugs for behavioral symptoms, such as agitation
• 31% are repurposed agents approved for other diseases, such as cancer or Parkinson’s disease

There were 48 trials (32 drugs) in Phase 3, 90 trials (81 drugs) in Phase 2, 26 trials (25 drugs) in Phase 1, and 11 long-term extensions of agents tested in prior trials. Currently active trials require 51,398 participants (36,998 in Phase 3; 13,138 in Phase 2; and 1,262 in Phase 1). DMT account of 79% of all participants required for current trials. On average, recruitment requires 2.1 years for a Phase 1 trial, 2.5 years for a Phase 2 trial, and 3.2 years for a Phase 3 trial. 

Four trials (3%) focus on prevention among cognitively normal individuals at risk for symptomatic Alzheimer’s disease (AD), while 42 trials (26%) target participants with mild cognitive impairment (MCI) with or without confirmation of AD pathology), 49 trials (30%) center on participants with early AD (MCI or mild AD dementia), and 75 trials (46%) include participants with mild, moderate, or severe AD dementia.

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.

FDA launches Center for Clinical Trial Innovation

The U.S. Food and Drug Administration (FDA)  has launched the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development. C3TI will enable internal and external parties to access information on clinical trial innovation efforts more easily, engage in collaborations, identify resources that can further support the use of innovative modalities, and identify development programs where a concerted approach to the use of clinical trial innovations would be productive. C3TI has selected three initial demonstration project areas, which were prioritized given their alignment with the Center’s broader objectives, their expected readiness of implementation and scalability, and the opportunity to improve lessons learned. C3TI intends to launch additional demonstration project areas as the C3TI Demonstration Program evolves. The initial project areas are: Bayesian Supplementary Analysis, Selective Safety Data Collection, and Streamlined Trials Embedded in Clinical Practice. See the CDER Conversation with Dr. Kevin Bugin, deputy director for operations in CDER’s Office of New Drugs and lead for C3TI, to learn more about the impetus for establishing C3TI and the center’s forward-facing goals and objectives.

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 long-term care facilities minimum staffing standards final rule

The Centers for Medicare & Medicaid Services (CMS) has issued the Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting final rule. Central to this final rule are new comprehensive minimum nurse staffing requirements, which aim to reduce the risk of residents receiving unsafe and low-quality care. CMS is finalizing a total nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care. Facilities may use any combination of nurse staff (RN, licensed practical nurse [LPN] and licensed vocational nurse [LVN], or nurse aide) to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard. CMS also is finalizing enhanced facility assessment requirements and a requirement to have an RN onsite 24 hours a day, seven days a week, to provide skilled nursing care. This final rule provides a staggered implementation timeframe of the minimum nurse staffing standards and 24/7 RN requirement based on geographic location as well as possible exemptions for qualifying facilities for some parts of these requirements based on workforce unavailability and other factors. 

Last year, CMS announced that it would invest over $75 million to launch a national nursing home staffing campaign to increase the number of nurses in nursing homes. CMS will be providing financial incentives for nurses to work in the nursing home environment. For example, nurses could receive tuition reimbursement for a specific commitment to work in a qualifying nursing home or in an oversight capacity with a state inspection agency. CMS will make it easier for individuals to become nurse aides by streamlining the process for enrolling in training programs and finding placement in a nursing home. CMS also will use the campaign to promote awareness of the many career pathways in the nursing field that are available to help recruit all types of individuals, from NAs to LPNs/LVNs and RNs. To help accomplish these tasks, CMS will launch an awareness campaign for these programs and the benefits of working in nursing homes. Additionally, CMS will collaborate with states and other partners  to bolster nurse recruitment. For example, states will be able to invest funds to improve nurse aide training information and increase the number of financial incentives available. 

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.

CMS advises states and territories receiving Money Follows the Person (MFP) funding on reporting requirements

During a recent All-State Call, the Centers for Medicare & Medicaid Services (CMS) advised the 41 states and territories receiving Money Follows the Person (MFP) funding about required reporting on a subset of the Home and Community-Based Services (HCBS) Quality Measures Set (SMDL 22-003). These states and territories must report on all section 1915(c), (i), (j), and (k) programs and section 1115 demonstrations that include HCBS services for major population groups, not just those programs that would enroll MFP participants. Reporting will be required in September 2026 for measures collected in 2025. Additional details on requirements and written guidance will be released by CMS at a later date. MFP states and territories that do not conduct a participant survey (on CMS’ approved list) will need to begin surveying later this year or in early 2025 (for NCI-AD states, this will be for the July 1, 2024 – June 30, 2025 survey cycle). The NCI-AD project team will be providing technical assistance and support to participating states to prepare to meet these new requirements. Please contact Rosa Plasencia with questions about the requirements or interest in joining NCI-AD.

HHS releases ACA Section 1557 final rule to protect civil rights in health programs

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has published a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination based on race, color, national origin, sex, age, and disability in covered health programs and activities. The regulation includes a number of provisions that are particularly relevant for older adults and people with disabilities. The final rule:

• Holds HHS’ health programs and activities to the same nondiscrimination standards as recipients of Federal financial assistance.
• For the first time, the Department will consider Medicare Part B payments as a form of Federal financial assistance for purposes of triggering civil rights laws enforced by the Department, ensuring that health care providers and suppliers receiving Part B funds are prohibited from discriminating on the basis of race, color, national origin, age, sex and disability.
• Requires covered health care providers, insurers, grantees, and others, to proactively let people know that language assistance services are available at no cost to patients.
• Requires covered health care providers, insurers, grantees, and others to let people know that accessibility services are available to patients at no cost.
• Clarifies that covered health programs and activities offered via telehealth must also be accessible to individuals with limited English proficiency, and individuals with disabilities.
• Protects against discrimination by codifying that Section 1557’s prohibition against discrimination based on sex includes LGTBQI+ patients.
• Respects federal protections for religious freedom and conscience and makes clear that recipients may simply rely on those protections or seek assurance of them from HHS.
• Respects the clinical judgement of health care providers.
• Protects patients from discriminatory health insurance benefit designs made by insurers.
• Clarifies the application of Section 1557 nondiscrimination requirements to health insurance plans.

Given the increasing use of artificial intelligence (AI) in health programs and activities, the rule clarifies that nondiscrimination in health programs and activities continues to apply to the use of AI, clinical algorithms, predictive analytics, and other tools. This clarification serves as one of the key pillars of HHS’ response to the President’s Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. Specifically, the rule: applies the nondiscrimination principles under Section 1557 to the use of patient care decision support tools in clinical care and requires those covered by the rule to take steps to identify and mitigate discrimination when they use AI and other forms of decision support tools for care.

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.

• Long COVID: plasma levels of neurofilament light chain in mild COVID-19 patients with neurocognitive symptoms (read here)
• Clinical trajectories preceding incident dementia up to 15 years before diagnosis: a large prospective cohort study (read here)
• APP C-Terminal Fragments Stifle Calcium Flow from ER to Lysosomes (read here)
• Oasis Or Mirage? Digital Dementia Screening In The Neurology Desert (read here)
• What is childhood dementia? And how could new research help? (read here)
• RNA modification is responsible for the disruption of mitochondrial protein synthesis in Alzheimer’s disease (read here)
• Spatiotemporal patterns of locus coeruleus integrity predict cortical tau and cognition (read here)
• Nanomaterial that mimics proteins could be basis for new neurodegenerative disease treatments (read here)
• Alzheimer’s and Arab Americans: More research needed (read here)
• National Trial Safely Scaled Back Prescribing of a Powerful Antipsychotic for the Elderly (read here)
• Alzheimer’s disease drug development pipeline: 2024 (read here)
• Essential tremor triples dementia risk, UTSW study shows (read here)
• Better heart health at midlife linked to less cognitive decline in Black women (read here)
• Global consortium to study Pick’s disease, rare form of early-onset dementia (read here)
• Understaffed Nursing Homes in Disadvantaged Neighborhoods More Likely to Overuse Antipsychotics (read here)
• Human brain small extracellular vesicles contain selectively packaged, full-length mRNA (read here)
• Innovative Microscopy Demystifies Metabolism of Alzheimer’s (read here)
• Finding hope in Alzheimer’s care  (read here)
• A linguistic warning sign for dementia (read here)
• In the brain, bursts of beta rhythms implement cognitive control (read here)
• Neuronal cell cycle reentry events in the aging brain are more prevalent in neurodegeneration and lead to cellular senescence (read here)
• Electroconvulsive Therapy in Individuals with Behavioral and Psychological Symptoms of Dementia (read here)
• St Petersburg University geneticists develop the world’s first bioinformatic tool to identify amyloids consisting of multiple proteins (read here)
• Study shows how depletion of mitochondria in axons can directly lead to protein accumulation (read here)
• Researchers use AI to improve Alzheimer’s disease treatment through the ‘gut-brain axis’ (read here)
• Could New Alzheimer’s Marker p-Tau212 Rival p-Tau217? (read here)
• The advent of Alzheimer treatments will change the trajectory of human aging (read here)
• Congress Must Act To Advance Innovation In Medicaid (read here)
• Analysis of the Association between Protein Intake and Disability-Adjusted Life Year Rates for Alzheimer’s Disease in Japanese Aged over 60 (read here)
• Tau Toggling Peptides: One Seeds Fibrils; the Other Dismantles Them  (read here)
• Early Alzheimer’s Treatment with Lecanemab Shows Reduced Disease Progression (read here)
• Can big data have a role in treating dementia? That’s what this Northeastern student is hoping to help solve (read here)
• Virtual reality study will assess link between navigation and Alzheimer’s disease (read here)
• Serum GFAP levels correlate with astrocyte reactivity, post-mortem brain atrophy and neurofibrillary tangles (read here)
• Estrogen-Only Hormone Therapy and Dementia (read here)
• Identification of senescent, TREM2-expressing microglia in aging and Alzheimer’s disease model mouse brain (read here)
• Reversal of the concreteness effect can be detected in the natural speech of older adults with amnestic, but not non‐amnestic, mild cognitive impairment (read here)
• Alzheimer’s Agitation Relapse Delayed With Dextromethorphan-Bupropion (read here)
• Obesity-Induced Cognitive Decline: Role of Brain Oxidation and Tocotrienols (read here)
• Despite FDA Delays, Experts Anticipate Donanemab Will Be Approved for Alzheimer’s Disease (read here)
• Joint transformer architecture in brain 3D MRI classification: its application in Alzheimer’s disease classification (read here)
• Trajectories of Occupational Cognitive Demands and Risk of Mild Cognitive Impairment and Dementia in Later Life (read here)
• USC study links lack of diversity in Alzheimer’s disease clinical trials to differences in amyloid levels (read here)
• Mentally stimulating work plays key role in staving off dementia, study finds (read here)
• The Path Bill Gates Sees to Overcoming Alzheimer’s Biggest Remaining Challenges (read here)
• The Heartbreak and Hazards of Alzheimer’s Caregiving (read here)
• Antipsychotics for dementia linked to more harms than previously acknowledged (read here)
• Common HIV treatments may aid Alzheimer’s disease patients (read here)
• How new long-term care models and tech can cut into billions spent on rehospitalizations (read here)
• Alzheimer’s disease progresses faster in people with Down syndrome (read here)
• ‘A Time of Hope’: Experts on Alzheimer’s Drug Breakthroughs (read here)
• WVU Alzheimer’s disease study focuses on broken connections (read here)
• Scientists identify cell vulnerability ‘fingerprint’ related to Parkinson’s, Lewy body dementia (read here)
• Higher drug burden score tied to poorer cognition, processing speed among older adults (read here)
• Awareness and cognitive rehabilitation in Alzheimer’s disease and frontotemporal dementia (read here)
• Repurposing non-pharmacological interventions for Alzheimer’s disease through link prediction on biomedical literature (read here)
• New mechanism uncovered in early stages of Alzheimer’s disease (read here)
• One-Minute Speech Test Could Help Assess Dementia Risk  (read here)
• Common dementia medication doesn’t increase risk of death, life-threatening heart abnormalities (read here)
• Local greenery and low crime rates may reduce dementia risk factors: study (read here)
• The Cognitive Health Clues of Long COVID (read here)
• Relationship of plasma biomarkers to digital cognitive tests in Alzheimer’s disease (read here)
• MIND Diet May Slow Aging and Lower Dementia Risk, Study Shows (read here)
• Extending the phenotypic spectrum assessed by the CDR plus NACC FTLD in genetic frontotemporal dementia (read here)
• Over the Span of AD, Roles of Astrocytes and Microglia Change  (read here)
• APOE3ch alleviates Aβ and tau pathology and neurodegeneration in the human APPNL-G-Fcerebral organoid model of Alzheimer’s disease (read here)
• Balancing act: Dementia care needs to change for safe integration (read here)
• Could Sumoylation Take Down Tangles? (read here)
• 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

BOLD Center on dementia detection publishes health systems toolkit 

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. 

• 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

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

1. 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.
2. 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)
• Protein modifications key influencers in neurodegenerative diseases (read here)
• Tracing synaptic loss in Alzheimer’s brain with SV2A PET‐tracer UCB‐J (read here)
• New genetic therapy could be a gamechanger for MND and frontotemporal dementia (read here)
• Epigenetic Shenanigans—In AD, Chromatin Opens Up in Blood Immune Cells (read here)
• Dementia: Could a new blood test predict it 15 years before symptoms? (read here)
• Pattern of thinning may predict dementia risk a decade before symptoms (read here)
• Family-based study identifies potential new genetic factors linked to Alzheimer’s risk in people with African ancestry (read here)
• Helping caregivers help people with dementia eat at home (read here)
• Dementia Researchers Share Recruitment Strategies for Pragmatic Clinical Trial (read here)
• Double risk of dementia after mouth ulcer virus (read here)
• Drug for Agitation in Alzheimer Disease Dementia Fails in Phase 3 Trial (read here)
• UC Irvine-led research team creates novel rabies viral vectors for neural circuit mapping (read here)
• Immune Genes Are Altered in Alzheimer’s Patients’ Blood (read here)
• Can AI Enhance MRI Detection of Amyloid-Related Abnormalities in Patients with Alzheimer’s Disease? (read here)
• The association of GNB5 with Alzheimer disease revealed by genomic analysis restricted to variants impacting gene function (read here)
• 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. 

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)
• 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)

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