NEWS

October, 2025 News

The LEAD Coalition along with member and allied groups join letter pressing Congress to finalize FY2026 Labor-HHS spending bill

On October 27, the Ad Hoc Group for Medical Research sent a letter to Congress urging appropriators to finalize the Fiscal Year (FY) 2026 Labor, Health and Human Services, Education, and Related Agencies spending bill with a robust investment in the National Institutes of Health. The letter, signed by over 450 organizations including the LEAD Coalition, specifically urges appropriators to provide no less than the Senate Appropriations Committee approved level of $47.2 billion for NIH, in addition to funding for the Advanced Research Projects Agency for Health (ARPA-H). The letter noted, “To ensure that funding supports the work of NIH effectively, it is imperative that Congress finalize the NIH funding level as quickly as possible; the bipartisan approach in S. 2587 both helps achieve that goal and upholds key attributes essential to the NIH’s success.” The LEAD Coalition helped secure support from a significant number of our member and allied organizations.

Congress remains at an impasse as shutdown enters week four 

As of October 23, the U.S. federal government has been shut down for 23 days – and a clear, bipartisan resolution to this impasse is not in sight. Republican leaders in the Senate assert that they will not enter substantive negotiations on policy issues such as health care until a clean continuing resolution (“CR”) is passed to reopen the government; Democrats are holding firm that they will only vote for a CR if it includes extensions to the Affordable Care Act tax credits and reverses recent Medicaid cuts. 

As November approaches, Senate Republicans soon will have to determine whether to replace the House-passed clean CR, which would extend government funding only through November 21, with a bill extending the CR into December or beyond. Less than one month is insufficient time for robust negotiations on the year-long spending bills. 

While the House has been held out of Session by the Speaker since late September, the Senate has  held votes on other measures including bills tied to federal worker compensation amid the shutdown. Although most federal employees are not permitted to work during the shutdown some are deemed “essential” and are reporting to their duty stations without the promise of a paycheck. Senate Republicans proposed a bill to pay these “essential workers” as well as military personnel on time, but this bill failed, with almost all Democrats opposing passage of a partial pay bill. As counter measures, Senate Democrats offered alternate bills to ensure all federal workers receive their paychecks.

Check this space for more updates over the coming days. For more details about the shutdown, please see previous entries on this page entitled “U.S. Federal government shutdown enters third week” and “U.S. Federal government enters shutdown; thousands of HHS employees furloughed.” For more information on the impact of the expiration of the tax credits, please review this Kaiser Family Foundation article.

U.S. federal government shutdown enters third week

The federal government has been closed for two full weeks and a resolution is not yet in sight. Since the shutdown began, the Senate has held numerous votes on two competing Continuing Resolution (CR) proposals to reopen the government while negotiations continue for FY 2026 appropriations bills:

• A House Republican-proposed “clean” CR to fund the government through November 21. Essentially, this bill would continue funding the government at current (FY 2025) levels and not include additional policy provisions.
• A Senate Democrat-proposed CR to fund the government at current levels and address key policy priorities to protect healthcare for millions of Americans (namely, extending Affordable Care Act tax credits and mitigating Medicaid cuts passed earlier this year on a partisan basis). 

Unfortunately, neither CR proposal has gathered the necessary 60 votes in the Senate to advance in the chamber. The most recent vote – held on the afternoon of October 16 – marked the tenth failed attempt to advance legislation. Top Republicans insist that an extension of the Affordable Care Act’s premium tax credits should not be a part of the current appropriations negotiations as the tax credit expiration deadline is not imminent. Democrats – as well as experts and leaders of state-based health insurance marketplaces across the U.S. – disagree, asserting that an extension realistically needs to pass by November 1, when open enrollment for these plans begins.

CMS issues final guidance for Medicare Drug Price Negotiation Program’s 2026 negotiations 

The Centers for Medicare & Medicaid Services (CMS) issued final guidance that details requirements and parameters for the third cycle of negotiations and the first cycle of renegotiations for the Medicare Drug Price Negotiation Program (“Negotiation Program”), which will occur during 2026 and may result in negotiated Maximum Fair Prices (MFPs) that would be effective beginning in 2028. In accordance with the Inflation Reduction Act of 2022 (IRA), CMS will select up to 15 additional negotiation-eligible drugs covered under Part D and/or payable under Part B for this third cycle of negotiations. CMS may also select drugs negotiated in the first or second cycles of negotiation to be renegotiated, if those selected drugs meet certain eligibility and selection criteria. This final guidance also includes additional clarifications and policies regarding how participating manufacturers will make any agreed upon negotiated MFPs available in 2026, 2027, and 2028. Additionally, CMS released a revised Drug Selection Information Collection Request (ICR) for the Medicare Drug Price Negotiation Program, covering the initial price applicability year 2028, for a 30-day public comment period ending October 30, 2025. The ICR package includes three components: the Small Biotech Exception, the Biosimilar Delay, and the Identification and Selection of Renegotiation-Eligible Drugs. For additional information, see CMS-10844 and CMS-10157 and the CMS fact sheet.

FDA clears Roche’s blood test for use in primary care to help rule out Alzheimer’s-related amyloid pathology

The U.S. Food and Drug Administration (FDA) has cleared Roche’s Elecsys® pTau181 blood test for use in primary care settings to help rule out Alzheimer’s-related amyloid pathology. Elecsys® pTau181 is the only FDA-cleared blood-based biomarker test indicated as an aid in the initial assessment of Alzheimer’s disease and other causes of cognitive decline in adults 55 and older. Developed in collaboration with Eli Lilly and Company, the test measures phosphorylated Tau (pTau181) protein in human plasma — a key biomarker associated with Alzheimer’s pathology, including amyloid plaque and tau aggregate formation. Results should be interpreted in conjunction with other clinical information. Importantly, the test is not intended to diagnose Alzheimer’s disease, but rather to help rule out the presence of Alzheimer’s-related pathology, supporting clinicians in identifying individuals whose cognitive decline may be due to other causes.

FDA grants fast track designation to BMS-986446 for the treatment of Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Bristol Myers Squibb’s BMS-986446, a drug currently in Phase 2 development (NCT06268886) for the treatment of early Alzheimer’s disease. This drug works by binding to specific regions of the tau protein to prevent cell-to-cell spread of the protein and tau uptake into cells. In preclinical models, BMS-986446 demonstrated significant reductions in tau uptake and spread, and was shown to be safe and well tolerated across three dose cohorts in a Phase 1 study of healthy participants. The ongoing Phase 2 study is fully enrolled and includes several biomarkers of tau and amyloid-beta biology, as well as clinical outcome measures, to evaluate the impact of BMS-986446 on disease progression. Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need. For additional information, see the BMS press release.

FDA issues final guidance documents on patient-focused drug development and expanded access to investigational drugs

The U.S. Food and Drug Administration (FDA) recently announced the availability of two new final guidance documents for patients and stakeholders.

The “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments” (Docket Number FDA-2022-D-1385) is the third in a series of four methodological guidance documents for industry, FDA staff, and other stakeholders that describe how patients, researchers, medical product developers, and others can submit patient experience and other relevant patient and caregiver information to be used for medical product development and regulatory decision-making. Guidance on clinical outcome assessments ultimately helps to ensure that assessments used during medical product development measure what matters to patients; are clear about what was measured; appropriately evaluate the effectiveness, tolerability, and safety of treatments; and avoid misleading claims. This guidance finalizes the draft guidance of the same title issued on June 30, 2022. Along with the guidance document, the FDA published resources including a guidance snapshot for industry audiences and a podcast.

FDA also has updated (October 2025) the “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers” (Docket Number FDA-2013-D-0446) guidance, which offers information for industry, researchers, physicians, institutional review boards, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (21 CFR part 312, subpart I). After these regulations went into effect on October 13, 2009, FDA received numerous questions concerning their implementation. As a result, FDA issued the 2016 (updated in 2017) guidance for industry Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers, providing recommendations in a question-and-answer format, addressing the most frequently asked questions. Since 2017, FDA has received additional questions concerning implementation of the regulatory and statutory requirements of expanded access to investigational drugs, including those added by the 21st Century Cures Act and the FDA Reauthorization Act of 2017.

NIH issues notice on key activities during federal government shutdown

On October 1, the National Institutes of Health (NIH) issued a notice titled “Information for the NIH Extramural Community During the Lapse of Federal Government Funding” (NOT-OD-26-004). In addition to the NIH contingency plan issued by the Department of Health and Human Services (HHS) in advance of the shutdown, the NIH notice reiterated information from the staffing plan and provided additional information about the status of key NIH activities:

• Related to the management of current, active grants, eRA Commons and grants.gov will be operational, but without technical support. Drawdown of funds will continue to be available, but technical problems and manual approval requirements could delay access to funds. Reporting deadlines for grantees remain in place without extension, even if no NIH staff can review the submissions during furlough. No-cost extension notifications for grants that will lapse during the shutdown should be submitted as usual, but those that require pre-approval will not be reviewed.
• For grant applications responding to active notices of funding opportunity, submission deadlines do not change, and NIH staff will be unavailable to answer questions or respond to technical difficulties.
• The Office of Laboratory Animal Welfare will not continue any activities during the shutdown.
• No NIH grant peer review meetings, advisory council meetings, issuance of new awards, and program/grants management activities will occur.
• New patients will not be admitted to the NIH Clinical Center (unless deemed medically necessary by the NIH Clinical Center Director).
• NIH will not hold scientific meetings at NIH facilities and NIH scientists will not travel to scientific meetings.
• Almost all NIH administrative functions will stop, including the onboarding of non-excepted staff, and many NIH employees will be unable to review or respond to emails, telephone calls, or mail.

CMS updates Medicare Advantage Plan disclosure requirements 

The Centers for Medicare & Medicaid Services (CMS) has issued a final rule (CMS-4208-F2) amending regulations on Medicare Advantage (MA) disclosure requirements. Beginning in 2026, the rule finalizes a new requirement for MA provider directory data to be submitted to CMS for publication online in accordance with guidance from the agency. Additionally, MA organizations must update their provider directory data within 30 days of becoming aware of a change to the data, and they are required to attest annually to the accuracy of the MA provider directory information. This policy follows guidance issued by CMS earlier this year addressing the addition of voluntarily reported MA provider directory information and the display of MA supplemental benefits in the Medicare Plan Finder tool. 

GSA Launches a New Series Highlighting Breakthroughs in Brain Health

The Gerontological Society of America (GSA) recently launched a new publication series, Insights & Implications: Understanding Breakthroughs in Brain Health, to help primary care providers stay up to date on dementia-related research advances and improve care trajectories for their patients. The inaugural issue, Understanding Breakthroughs in Brain Health: Top 10 Articles of 2024, provides a compilation of the insights and implications from key scientific articles with important impact on primary care for brain health. Major topics covered in this issue include detection and diagnosis, risk reduction, and care pathways.

Additional Reads

• NIH Alzheimer’s Research Funding Is Back — for 49% Fewer Projects (read here)
• Friendships can ease loneliness for dementia caregivers (read here)
• Dementia risk doubles or triples for people who are lonely, depressed, study finds (read here)
• Dementia: New Model of Home Care Proves Effective in Practice (read here)
• RNA tech could make fast test for Alzheimer’s disease (read here)
• First direct measurement of dementia-linked proteins (read here)
• CTE and Alzheimer’s: Overlapping Pathologies, Shared Challenges (read here)
• Add-on combination therapy with monoclonal antibodies: Implications for drug development (read here)
• The female factor in Alzheimer’s: UNSW study probes hormonal links to dementia. (read here)
• All of a sudden, dementia treatment is becoming very exciting (read here)
• Small study suggests 40Hz sensory stimulation may benefit some Alzheimer’s patients for years (read here)
• Gamma sensory stimulation in mild Alzheimer’s dementia: An open‐label extension study (read here)
• Longitudinal changes in triglyceride-glucose index and the risk of incident dementia: a prospective cohort study (read here)
• The 25-Year Incidence and Progression of Hearing Loss (read here)
• In a Sea of CAA Proteins, CRIP1 Surfaces as a Potential Biomarker (read here)
• Untangling Alzheimer’s: ASU researchers tackling our understanding of the disease on many fronts (read here)
• Air Pollution-Related Dementia Kills Over 625,000 People A Year (read here)
• Media imagery paints a one-sided and fear-inducing picture of dementia (read here)
• Alzheimer’s disrupts circadian rhythms of plaque-clearing brain cells (read here)
• Inside the U.S. POINTER Study: How Lifestyle Changes Improved Memory (read here)
• UC Irvine researchers find new Alzheimer’s mechanism linked to brain inflammation (read here)
• Dementia linked to problems with brain’s waste clearance system (read here)
• Algorithm maps genetic connection between Alzheimer’s and specific neurons (read here)
• Scientists find ways to boost memory in aging brains (read here)
• Association of Inpatient Prescribing of First‐Generation Antihistamines With Delirium in Older Adults: A Cross‐Sectional Study (read here)
• Corporate support cannot make up for threats to the NIH budget (read here)
• $27.2 Million National Effort Launches to Unify Alzheimer’s Research Data (read here)
• Relationship between dementia diagnostic characteristics and severity of depressive symptoms in a cross-sectional analysis of HOMESIDE baseline data (read here)
• Why APOE4 raises Alzheimer’s risk (read here)
• New blood test could streamline Alzheimer’s diagnosis and treatment access (read here)
• Apple-Tree intervention offers hope and support for people facing memory loss (read here)
• History of Alzheimer’s Disease Research Centers: From inception in 1984 to evolution beyond 2025 (read here)
• Sensory processing assessment in Alzheimer’s disease and related dementias: Opportunities for improved care (read here)
• Alector Therapeutics Announces Results From Their Phase 3 Clinical Trial Evaluating Latozinemab (read here)
• Francis S. Collins Joins ImmunoBrain Board of Directors (read here)
• Can digital replicas of patients help personalize Alzheimer’s treatment? (read here)
• The DNA as a musical score and the key of epigenetics to understand Alzheimer’s (read here)
• Precision Diagnosis: The New Paradigm for Neurocognitive Disorders (read here)
• Targeting brain immune cells could restore Alzheimer’s-related lipid imbalance (read here)
• Impact of Dementia on Patients Admitted With Complicated Diverticular Disease: A U.S. Nationwide Analysis (read here)
• Type 1 Diabetes Linked to Increased Dementia Risk (read here)
• FDA review of drugs is slowing while application delays are growing, analysis finds (read here)
• Whole-brain, bottom-up neuroscience: The time for it is now (read here)
• The Telehealth Cliff Has Arrived: What’s Changing and What to Watch (read here)
• Helpline support eases stress for dementia caregivers (read here)
• Former NIH leaders lament ‘constant chaos’ at the agency, and caution it’s not over (read here)
• CMS walks back Medicare payment pause (read here)
• New Trial Finds Diabetes Drug and Nasal Insulin Improve Brain Health in Early Alzheimer’s Disease (read here)
• ‘Death fold’ proteins can make cells self-destruct. Scientists want to control them (read here)
• No amount of alcohol is safe, at least for dementia risk, study finds (read here)
• Microglia-specific regulation of lipid metabolism in Alzheimer’s disease revealed by microglial depletion in 5xFAD Mice (read here)
• People with dementia less likely to be referred to allied health services by GPs (read here)
• New brain imaging technique can detect early frontotemporal dementia (read here)
• Medicare backs off plan to pause doctor payments amid shutdown (read here)
• Eye-tracking offers measure of change in pre-clinical Alzheimer’s Disease (read here)
• Understanding Cellular Impacts of Neurodegeneration (read here)
• New nanoparticle treatment helps brain to clear toxic Alzheimer’s proteins in mice (read here)
• Whiplash at CDC as hundreds of employees are terminated, then reinstated (read here)
• Why time could be as critical as diet and exercise for brain health (read here)
• Common hospice medications linked to higher risk of death in people with dementia (read here)
• Celebrating neuropathology’s contributions to Alzheimer’s Disease Research Centers (read here)
• The word ‘dementia’ is about to lose its value (read here)
• Stiff Arteries May Amplify Early Memory Decline in Older Adults (read here)
• Cellular Railroad Switches: How Brain Cells Route Supplies to Build Memories (read here)
• Outcomes With Donanemab for Early Symptomatic AD (read here)
• Music for the brain: Study tests the effect of slow-tempo relaxing music to address delirium in critically ill older adults (read here)
• Sex differences in healthy brain aging are unlikely to explain higher Alzheimer’s disease prevalence in women (read here)
• Sex/gender differences in lifetime dementia risk among Asian American and White older adults (read here)
• Faster MRI scans offer new hope for dementia diagnosis (read here)
• Study finds early menopause is associated with increased risk of dementia (read here)
• Nationwide Study Uncovers Alzheimer’s Risk Factors in MCI (read here)
• Broadening dementia risk models: building on the 2024 Lancet Commission report for a more inclusive global framework (read here)
• Plasma p‐tau217 and Aβ42/40 as markers of Aβ pathology in the Lewy body continuum (read here)
• Could dementia be the key to saving endangered Jewish languages? (read here)
• NIH Leadership Is Failing Early Career Researchers (read here)
• Trump administration begins laying off federal workers amid shutdown (read here)
• What the Science Says: Long COVID, Brain Health, and Cognitive Decline (read here)
• My mother had Alzheimer’s. I watched her slip away in the fragile care system (read here)
• “My young-onset dementia symptoms were dismissed as menopause” (read here)
• Cholesterol-lowering drugs could reduce the risk of dementia, study finds (read here)
• Risk of stroke associated with risperidone in dementia with and without comorbid cardiovascular disease: population-based matched cohort study (read here)
• IoMT driven Alzheimer’s prediction model empowered with transfer learning and explainable AI approach in healthcare 5.0 (read here)
• TDP-43 Knockdown Kicks Off a Cascade of Protein Changes (read here)
• A new chip could help scientists track Alzheimer’s disease as it unfolds in real time (read here)
• Can a keto diet help protect brain energy? (read here)
• Breakthrough in blood test for Alzheimer’s by University of York researchers (read here)
• First Large-Scale Alzheimer Disease Study in Brain Tissue from African American Donors Implicates Roles for Many Novel Genes (read here)
• Novel differentially expressed genes and multiple biological pathways for Alzheimer’s disease identified in brain tissue from African American donors (read here)
• Automated Alzheimer’s disease detection using active learning model with reinforcement learning and scope loss function (read here)
• He Was Expected to Get Alzheimer’s 25 Years Ago. Why Hasn’t He? (read here)
• UMass Chan scientists show how non-neuronal brain cells communicate to coordinate rewiring of brain (read here)
• ECU research debunks link between calcium supplements and dementia (read here)
• Scientists reverse Alzheimer’s in mice using nanoparticles (read here)
• Synaptic changes in the brains of patients with frontotemporal dementia can be modeled in patient-​derived neurons in the laboratory (read here)
• Rate of incident dementia and care needs among older adults with new traumatic brain injury: a population-based cohort study (read here)
• Salivary mitochondrial DNA is associated with biomarkers of Alzheimer’s disease in cognitively normal older adults (read here)
• Antidepressant-Resistant Depression Increases Dementia Risk in Older Adults (read here)
• Ten-Year Death Trends Related to Dementia, Alzheimer’s Disease, and Epilepsy in England and Wales (2014–2023): A Descriptive Analysis of National Death Registration Data (read here)
• Potential Alzheimer’s treatment, trontinemab, hits the news – how does it work and is it available? (read here)
• Can Annual Eye Checkups Reduce Risk of Alzheimer’s and Other Dementias? (read here)
• Creativity could be prescribed to improve brain health, study suggests (read here)
• HKUST Scientists Reveal Critical Impacts of a Chinese Genetic Risk Factor in Alzheimer’s Disease (read here)
• Education protects memory even in people over 90 (read here)
• Seeing Is Knowing: Introducing the Digital Neuropathology Collection (read here)
• Losing your sense of smell? It could be an early sign of Alzheimer’s or Parkinson’s disease (read here)
• COVID-19 infection associated with increased risk of new-onset vascular dementia in adults ≥50 years (read here)
• People with Down syndrome have early neuroinflammation (read here)
• Brain shape changes could offer early warning signs of dementia (read here)
• Liverpool scientists create affordable, AI-powered tests for early detection of Alzheimer’s disease (read here)
• Molecular hallmarks of excitatory and inhibitory neuronal resilience to Alzheimer’s disease (read here)
• Telehealth Is About to Abruptly End for Seniors (read here)
• Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEε4/ε4 Homozygotes with Early Alzheimer’s Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial (read here)

September, 2025 News

Late Breaking News Update: U.S. Federal Government Enters Shutdown; Thousands of HHS Employees Furloughed

At 12:01 on October 1, the federal government officially entered a shutdown after the Senate failed to pass funding legislation.

Late on September 30, the Senate held votes on two Continuing Resolution (CR) options –  a House Republican-proposed “clean” CR to fund the government through November 21, and a Democrat-proposed short-term CR that aimed to address key priorities to protect healthcare for millions of Americans (namely, extending Affordable Care Act subsidies and mitigating Medicaid cuts). Both failed to muster the 60 votes needed to pass the chamber.

Now, most non‑essential operations will halt, and hundreds of thousands of federal employees are expected to be furloughed or work without pay. In an aggressive posture preceding the shutdown, the White House Office of Management and Budget (OMB) instructed federal agencies to draft plans for mass firings/layoffs of furloughed employees in the event of a funding lapse. The Department of Health and Human Services (HHS) expects 41 % of its workforce to be furloughed (32,460 of 79,717 employees). The Centers for Disease Control and Prevention (CDC) is set to furlough 64% of its staff. The National Institutes of Health (NIH) would furlough over 75% of its workforce, halting grant peer reviews, advisory council meetings, and basic research. The Food and Drug Administration (FDA) is expected to retain 86% of its workforce, while the Centers for Medicare and Medicaid Services (CMS) would keep 53% of employees.

Services deemed essential—such as Social Security, Medicare, and Medicaid payments and matters of national security—will continue, though potentially under strain.

Check this space for updates over the coming days.

LEAD Coalition executive director and federal policy director submit response to CMS on 2026 Medicare PFS proposed rule

On September 12, the LEAD Coalition Executive Director and Federal Policy Director submitted a public comment  letter to the Centers for Medicare & Medicaid Services (CMS) in response to Docket Number CMS-1832-P: Calendar year 2026 proposed policy changes for Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B issues. The letter supported an array of proposed activities, including incentives to improve detection of cognitive impairment in primary care settings, a quality measure to capture reports of falls, improvement activities relating to oral health and diabetes, reduction of barriers to telehealth, and efforts to enhance care for chronic disease management. The letter also objected to the proposed removal of several quality measures related to health equity, such as the deletion of the Social Determinants of Health (SDOH) Risk Assessment, and removal of a measure on vaccination status.

LEAD Coalition Supports Passage of the CHANGE Act

The LEAD Coalition has submitted a letter to Congress, signed by 400 LEAD Coalition member organizations and allies, encouraging Members of Congress to co-sponsor the CHANGE Act (S. 1799 / H.R. 3501). This bipartisan legislation would better utilize the existing Welcome to Medicare initial exam and Medicare annual wellness visits to strengthen detection of cognitive impairment, potentially leading to an earlier diagnosis of Alzheimer’s disease and related dementias in their earliest stages. An early documented diagnosis communicated to the patient and caregiver enables timely access to care planning services along with available medical and non-medical treatments, and optimizes peoples’ ability to build a care team, participate in support services, and enroll in clinical trials. 

LEAD Coalition member and allied organizations are encouraged to use the letter to support their efforts to educate Congress and the public about the CHANGE Act and the importance of early detection of cognitive impairment.

NIH releases Annual AD/ADRD Professional Judgment Budget and Scientific Progress Report

On September 8, the National Institutes of Health (NIH) released the FY2027 AD/ADRD Professional Judgment Budget (webpage and PDF) and its companion document, the 2025 AD/ADRD Scientific Progress Report (webpage and PDF). These two documents, released on an annual basis, provide the broader research community with a prospective look into, and retrospective review of, NIH AD/ADRD research. (Read the blog, co-authored by NIH director Dr. Jay Bhattacharya and NIA director Dr. Richard Hodes.)

The Professional Judgment Budget, mandated by Congress through the Alzheimer’s Accountability and Investment Act, serves as a professional estimate of the additional funds needed to continue to advance AD/ADRD research. Importantly, this estimate is developed solely by scientific experts at NIH, and sent directly to Congress without change by the U.S. Department of Health and Human Services (HHS) nor the White House Office of Management and Budget (OMB). For FY2027, NIH estimates $187.2 million in additional funds are needed to advance scientific research, bringing the total required resources to $4.046 billion. Along with the budget estimate, NIH details research opportunities that could be pursued with the additional funding. Examples include opportunities to expand longitudinal studies and incorporate real world data, investigate disease mechanisms of action with cutting edge tools, validate biomarkers and disseminate diagnostic advances to clinicians, develop tools to aid translational research, explore new therapeutic modalities, and more. The report also describes cross-cutting research opportunities centered on open science and secondary analyses of existing data.

The complementary AD/ADRD Scientific Progress Report features a summary of promising science advances from the past year. These include progress in drug development and repurposing, behavioral and lifestyle interventions, diagnosis, dementia risk and protective factors, underlying biological pathways, care and caregiving research, and career training.

Together, these reports demonstrate the importance of predictable and growing federal investment in AD/ADRD research – they document the tremendous progress made possible by years of congressionally appropriated  funding increases and offer examples of additional research advancements that could be facilitated by continued investments. All previous reports can be found on the NIA website.

House Appropriations Committee advances FY2026 Labor-HHS bill with $7B in cuts to HHS; slight increase to NIH budget

On September 9, by a bipartisan vote of 35-28, the House Appropriations Committee approved the proposed Labor, Health, and Human Services (Labor-H) appropriations bill for FY2026 (see: accompanying report language). The bill proposes an overall $6.8 billion cut to the Department of Health and Human Services (HHS), or a reduction of 6% from the FY2025 level. Major cuts include:

• $7.4 billion for Centers for Disease Control and Prevention (CDC), a decrease of $1.7 billion below the FY2025 level. 
• $7.1 billion for Health Resources and Services Administration (HRSA), a decrease of $886 million below the FY2025 level.
• Eliminates funding for the Agency for Healthcare Research and Quality (AHRQ), a cut of $369 million below the FY2025 level.

Conversely, the bill rejects the drastic cuts to biomedical research proposed in the President’s Budget by recommending $47.8 billion for the National Institutes of Health (NIH), i.e., $46.9 billion for NIH’s base budget and $945 million for the Advanced Research Projects Agency for Health (ARPA-H). Although the overall NIH total reflects a 1% decrease from the FY2025 level, the bill includes a $99 million (0.2%) increase to the NIH base budget relative to the comparable $46.8 billion FY2025 level. The decrease comes entirely from ARPA-H funding, which would suffer a $555 million cut (-37%) below the FY2025 level.

Specific to Alzheimer’s disease and related disorders research at NIH, the bill includes $4.5 billion for the National Institute on Aging (equivalent to the FY2025 level) and $2.6 billion for the National Institute of Neurological Disorders and Stroke, an increase of $30 million above the FY2025 level. Notably, the bill excludes any provisions to reorganize the NIH. Although members on both sides of the aisle deserve credit for supporting scientific research and rejecting the President’s proposed 40% cut to NIH, the LEAD Coalition remains concerned that a minimal increase to the NIH budget will not be sufficient to keep pace with inflation and actual growth in costs of biomedical research.

The bill also rejects substantial cuts proposed in the President’s Budget for the Administration for Community Living (ACL).  The bill includes $2.5 billion for ACL, a decrease of $11 million below the FY2025 level.  Although a small cut, this comes at a time when demand for services is increasing and likely will begin to grow even more rapidly as the $1 trillion cut to Medicaid begins to take effect.

During the full committee markup, eight amendments were adopted, including an amendment offered by Congresswoman Lois Frankel that would prevent the Centers for Medicare and Medicaid Services (CMS) from running a prior authorization pilot. Senate and House Appropriators now must negotiate a final bill by the September 30 deadline. Some reports indicate that Senate and House Appropriators are eager to pass a short stopgap bill (or continuing resolution, i.e., a “CR”) soon, which would put off the deadline for these negotiations into November. The White House has weighed in, suggesting that a stopgap bill should run through the end of January.

LEAD Coalition supports congressional action to prevent OMB from instituting arbitrary caps on federal support for research costs

More than 160 national organizations, including the LEAD Coalition, have sent a letter to congressional appropriators urging strengthened language in the final spending bills supporting the Joint Associations Group on Indirect Costs (JAG) Financial Accountability in Research (FAIR) model and prohibiting the Office of Management and Budget (OMB) from instituting arbitrary caps on federal support for research costs. In the FAIR model, the JAG has put forward a proposal that further enhances transparency and accountability associated with the federal government’s support for these real expenses at research institutions across the country. Developed by subject matter experts from within and beyond the research community and informed by elements of the private foundation funding model and industry charging structures, the approach enhances visibility of research costs for taxpayers, government officials, researchers, and institutions alike, without undermining the critical support that makes research possible. 

LEAD Coalition joins national patient advocacy groups urging Congress to support robust medical research funding

The LEAD Coalition has joined with nearly four dozen leading national patient groups, representing millions of Americans living with chronic and acute diseases, in sending a letter to House Appropriators urging them to protect robust federal funding for medical research in FY2026. The letter, coordinated by UnitedforCures (press release), observes that continued public investment in research is critical to advancing prevention and early detection efforts, developing innovative treatments, and finding life-saving cures. Sent just ahead of the House LHHS subcommittee markup, the letter warns that cutting federal medical research funding would impose devastating consequences on all Americans. 

FDA announces real-time release of Complete Response Letters

The U.S. Food and Drug Administration (FDA) has announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released 89 previously unpublished CRLs issued from 2024 to the present associated with pending or withdrawn applications. Decision letters are accessible to the public as a centralized dataset at openFDA. Each of these CRLs detail specific safety and effectiveness deficiencies identified by the FDA as preventing the application from receiving approval. Going forward, the agency will release newly issued CRLs and, when approving applications, will release all CRLs associated with that application. The agency will publish batches of previously issued CRLs associated with withdrawn or abandoned applications. All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.

According to the FDA, publishing CRLs offers important benefits for public health, including empowering drug developers to avoid common missteps and efficiently bring more cures and meaningful treatments to the American public, delivering greater insight to patients and the health care providers who treat them, and ensuring sponsors provide complete and contextualized information in communications to investors and shareholders. The publication of all CRLs also complies with the President’s direction to all agencies, via Executive Order No. 14303, to release “data, analyses, and conclusions associated with scientific and technological information produced or used by the agency that the agency reasonably assesses will have a clear and substantial effect on important public policies or important private sector decisions.” 

New publication outlines importance of investing in Alzheimer’s disease research for next generation of adults with Down Syndrome

A recent open access publication in Alzheimer’s & Dementia outlines the health, community, and economic benefits of more systemic and deliberate investment in the treatment of Alzheimer’s disease in adults with Down syndrome (DS). The paper, “Investment in Alzheimer’s disease research for the next generation of adults with Down syndrome will yield health benefits for future generations,” describes a population simulation and projection model developed by the RAND Corporation to estimate the impact of such targeted investment between 2020 and 2070. Over these 50 years, DS adult lifespan would increase by five years, without any increase in unhealthy years of life for individuals living with Down syndrome-associated Alzheimer’s disease (DS-AD). Additionally, though caregiving costs would be roughly $1 billion per year, DS-AD innovations could reduce caregiving hours by nearly 40% by 2070, which could generate large annual savings. 

GSA releases new resources to assist health care providers and care partners 

The Gerontological Society of America (GSA) has released publications to aid health care providers and caregivers engaging with older adults. The first resource, Communicating with Older Adults:  A Review of What Really Works, is an evidence-based guide to help health care providers and caregivers enhance communication with older adults. This report provides practical, respectful strategies – e.g., the teach-back method, active listening, and the LEARN model – to support more effective interactions and improve health outcomes. This guide may be particularly helpful in aiding communications with older adults facing lower health literacy, sensory challenges, and/or cognitive changes. Another resource, Helping Patients Make Health Care Decisions, is designed to guide health care professionals in effectively supporting older adults as they navigate complex medical choices. Through case-based examples and practical communication strategies, this resource explores wide-ranging clinical, cultural, emotional, and financial factors that influence patient decision-making. From overcoming age-related bias to building strong provider-patient relationships and honoring religious and cultural values, this guide equips clinicians with actionable tools to promote informed, respectful, and patient centered care.

Additional Reads

• Bridging the Diversity Gap: Why Alzheimer’s Research in Africa Matters (read here)
• Life Purpose Lowers Risk for Cognitive Impairment in a United States Population-Based Cohort (read here)
• The way we talk about dementia is about to change completely (read here)
• New fiber-optic method tracks Alzheimer’s plaques in active mice (read here)
• What the Science Says: Long COVID, Brain Health, and Cognitive Decline (read here)
• Cutting country dementia risks through community collaboration (read here)
• TTUHSC Researchers Find Blood-Brain Barrier Remains Resilient in Alzheimer’s Disease Model (read here)
• Slowly crossing the blood–brain barrier takes time (read here)
• Bridging Silos: Aligning State Health Improvement, Aging, and Dementia Plans (read here)
• FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity (read here)
• Why Is Alzheimer Disease More Common in Women? (read here)
• Repeated Blows to the Head Nix Neurons Nestled in Brain’s Folds (read here)
• As Dementia Rises, More Older Americans Are Getting Care at Home. It’s Not Without Challenges. (read here)
• Personalized Music Intervention in Agitated Patients With Alzheimer’s Disease (read here)
• Penn State to co-lead national brain health and dementia prevention initiative (read here)
• 4 vaccines linked to a lower risk of dementia, according to science (read here)
• New protein interaction map sheds light on how brain cell communication breaks down in Alzheimer’s disease (read here)
• Independent validation of the PrecivityAD2™ blood test to identify presence or absence of brain amyloid pathology in individuals with cognitive impairment (read here)
• Special Report: “Living With Dementia: Learning from Cultural Narratives of Aging Societies” (read here)
• Mortality and institutionalization of patients with dementia treated in primary care: influence of neuropsychiatric symptoms (NeDEM project) (read here)
• Sociodemographic traits as early indicators of AD, FTD, and VaD up to 10 years before diagnosis (read here)
• Low labour market participation may be the first sign of dementia up to ten years before diagnosis (read here)
• Protein in urine can predict risk of dementia (read here)
• The great revolution against Alzheimer’s: ‘It’s the first time in human history that we’ve managed to slow the disease’ (read here)
• There is no safe amount of alcohol when it comes to dementia, study finds (read here)
• TDP-43 Missplicing: A Common Factor in Neurodegenerative Disease? (read here)
• How States Can Mitigate The Harm Of HCBS Cuts (read here)
• New landscape of the diagnosis of Alzheimer’s disease (read here)
• Lewy Body Dementia Treatment: What Helps Now, and What’s in Clinical Trials (read here)
• Why women bear the burden of dementia: Unraveling the sex gap (read here)
• Birthright Citizenship and Medicaid Coverage at a Constitutional Crossroads (read here)
• Rethinking Alzheimer’s: Why this common gene variant is bad for your brain (read here)
• Combining Lumipulse p‐tau217 and Aβ42/40 as confirmatory tests for Aβ positivity prior to disease‐modifying therapy (read here)
• Vascular Disease is an Overlooked Contributor to Dementia, UNM Researcher Finds (read here)
• Her dad doesn’t speak English. Without the right care help, she can’t get a break. (read here)
• FDA rescinds lab-developed test rule after court order (read here)
• Tariffs: Added Strain On The US Health Care System | Health Affairs (read here)
• NIH outlines new system for awarding research grants to foreign scientists (read here)
• Training hospital staff in person-centred dementia care improves recovery outcomes (read here)
• An Inside Look at How Doctors Diagnose Lewy Body Dementia (read here)
• Global experts unite to redefine diagnostic criteria for vascular dementia (read here)
• Does physical frailty contribute to dementia? (read here)
• Brain Border-Associated Macrophages Take Blame for Spreading Senescence (read here)
• Largest ever TauPET study of Alzheimer’s deepens understanding of the disease (read here)
• Brain training and healthy snacks show promise for older adults with less education (read here)
• Cellular crosstalk in the brain sheds light on Alzheimer’s progression (read here)
• The Hidden Link between Racism and Alzheimer’s Risk (read here)
• Improving Fire Safety In Assisted Living (read here)
• The TREM2 H157Y variant is associated with more severe neurodegeneration in Alzheimer’s disease and altered immune‐related processes (read here)
• The New Brain Economy: An Economic Strategy to Boost the Longevity Dividend (read here)
• Turning Music Into Care For Alzheimer’s Patients (read here)
• Donanemab in preclinical Alzheimer’s disease: Screening and baseline data from TRAILBLAZER‐ALZ 3 (read here)
• Revised Diagnostic Criteria for Vascular Cognitive Impairment and Dementia—The VasCog-2-WSO Criteria (read here)
• Menopause, Hormone Therapy, and Alzheimer’s: Why HRT Timing Matters (read here)
• Increasing the level of the protein PI31 demonstrates neuroprotective effects in mice (read here)
• Baylor researchers uncovered how physical activity helps improve memory in Alzheimer’s disease (read here)
• Researchers Show How Healthy Habits Can Improve Cognitive Decline (read here)
• Primary care detection of Alzheimer’s disease using a self-administered digital cognitive test and blood biomarkers (read here)
• U-M scientists discover unique brain cell that may hold key to Alzheimer’s disorientation (read here)
• Use of psychotics twice as high in aged care residents with dementia (read here)
• Dementia Mortality and Health Care Utilization Higher Among Men (read here)
• Building bridges between Alzheimer’s theories (read here)
• Creating User Personas to Represent the Needs of Dementia Caregivers Who Support Medication Management at Home: Persona Development and Qualitative Study (read here)
• Social lifetime experiences have long-lasting effects on mental and brain health (read here)
• FDA leaders moving to abandon advisory committee reviews of specific new drugs (read here)
• Childhood Loneliness and Cognitive Decline and Dementia Risk in Adulthood (read here)
• Multiple Ancestries Tell Similar Tale of Alzheimer’s Risk (read here)
• After lagging far behind, NIH now seems on pace to spend its entire $47 billion budget by Sept. 30 (read here)
• Study shows how visual landmarks tune the brain’s internal compass (read here)
• Portable light-based brain monitor shows promise for dementia diagnosis (read here)
• For migrants, dementia can mean losing a language – and a whole world (read here)
• New study links blood proteins to Alzheimer’s disease and memory loss (read here)
• Junk Food Puts Memory at Risk—Here’s How to Protect It (read here)
• Novel AI-powered eye scan predicts risk of cognitive decline and dementia (read here)
• Researchers discover cell defect linked to the development of Alzheimer’s (read here)
• Rice scientists develop ‘molecular magnifying glass’ to help identify diseases earlier (read here)
• Protein Found in the Eye and Blood Significantly Associated with Cognition Scores (read here)
• Menopause, Brain Fog, Alzheimer’s: What Women Should Know (read here)
• Monitoring and Managing ARIA in Antiamyloid Treatments (read here)
• Strong association between psychiatric disorders co-occurrence and dementia: a Bayesian approach on a 14-year clinical data warehouse (read here)
• Lewy Body Dementia: Symptoms, Causes, Risk Factors, and Diagnosis (read here)
• Purdue-led study shows how fat disables the brain’s immune shield in Alzheimer’s disease (read here)
• Can we detect Alzheimer’s disease decades before symptoms start? (read here)
• Zero burden technologies show that brighter days and cooler nights could improve sleep in dementia (read here)
• Brain Iron on MRI Predicts Cognitive Impairment, Decline (read here)
• Alzheimer’s erodes brain cells’ control of gene expression, undermining function, cognition (read here)
• Incidence and Prevalence of Frontotemporal Dementia (read here)
• UVA study of identical twins links faster aging to memory decline (read here)
• Air pollution linked to faster buildup of toxic proteins in Alzheimer’s brains (read here)
• Blood Test Could Streamline Early Alzheimer’s Detection (read here)
• Game-based training boosts memory and brain function in early dementia, studies find (read here)
• Computer games could level up cognitive function in people living with dementia (read here)
• The silent killer increases your risk of stroke and dementia. Here’s how to control it  (read here)
• Frailty and Risks of Dementia among Middle-aged and Older Adults: Evidence from Three Prospective Cohort Studies (read here)
• Alzheimer Disease Biomarkers and Cognitive Decline in Hispanic and/or Latino Adults (read here)
• D-CARE study finds caregiver satisfaction higher with dementia care programs than usual care (read here)
• Structure of clusterin decoded: New insights into the function of a risk factor for Alzheimer’s disease (read here)
• Study establishes link between rugby and dementia (read here)
• Clinical progression on CDR‐SB©: Progression‐free time at each 0.5 unit level in dominantly inherited and sporadic Alzheimer’s disease populations (read here)
• Using new blood biomarkers, USC researchers find Alzheimer’s disease trial eligibility differs among various populations  (read here)
• Stroke, Cardiovascular Disease, and Dementia After Hospitalized TIA (read here)
• How Two Genes Interact to Accelerate Alzheimer Disease’s Onset in African-Ancestry Populations (read here)
• How ‘brain cleaning’ while we sleep may lower our risk of dementia (read here)
• Researchers Reveal Potential Molecular Link Between Air Pollutants and Increased Risk of Lewy Body Dementia (read here)
• Misdirected: Increased Dementia Risk Associated with Errors of the “Brain’s Compass” (read here)
• Driven to understand: What driving data reveals about dementia (read here)
• The tale of donanemab: God is in the details (read here)
• Building bridges in a memory care desert (read here)
• Scientists Look to Commercial Dyes to Help them Diagnose Dementia (read here)
• Machine Learning to Detect Motor Agitation in People With Dementia Using Real-Time Location Data (read here)
• What your spatial awareness reveals about your dementia risk (read here)
• Can You Trust Brain Supplements? Experts on Hype, Hidden Dangers (read here)
• Unmet Needs in Dementia Care After Formal Diagnosis (read here)
• Gene variant slows down removal of debris in the brain, increasing Alzheimer’s risk, say USF Health researchers (read here)
• Study Reveals Surprising Link Between HIV and Alzheimer’s (read here)
• The National Dementia Workforce Study: Development of Questionnaires for Home Care, Assisted Living, and Nursing Home Settings (read here)
• Biomarker-related phospho-tau217 appears in synapses around Aβ plaques prior to tau tangle in cerebral cortex of preclinical Alzheimer’s disease (read here)
• These scientists found Alzheimer’s in their genes. Here’s what they did next (read here)
• Early Alzheimer’s brainwave test detects memory decline years before diagnosis (read here)
• Alzheimer’s erodes brain cells’ control of gene expression, undermining function and cognition (read here)
• Restrictive criteria for frontotemporal dementia lead to late treatment (read here)
• Africa Is Seeing a Surge of Dementia Cases. Families Aren’t Sure What to Do. (read here)
• Birth weight, incident dementia risk, and PET amyloid burden: The ARIC study (read here)
• FDA Approved: An Injectable Version of Alzheimer’s Drug Leqembi (read here)
• Exploring criminal behavior in patients with dementia (read here)
• ‘My dementia diagnosis was not the end of the world’ (read here)

August, 2025 News

Late Breaking News: FDA approves LEQEMBI® IQLIK™subcutaneous injection for maintenance dosing 

On August 29, the U.S. Food and Drug Administration (FDA) approved Eisai’s Biologics License Application (BLA) for lecanemab-irmb subcutaneous autoinjector (U.S. brand name: LEQEMBI® IQLIK™, pronounced “I Click”) for weekly maintenance dosing. LEQEMBI IQLIK is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). LEQEMBI is the first and only anti-amyloid treatment with an at-home injection option to help patients and care partners continue to treat this disease after initial treatment of 18 months. LEQEMBI IQLIK will be launched in the U.S. on October 6. (See: Eisai’s Approach to U.S. Pricing for LEQEMBI IQLIK.)

The BLA was based on data from sub-studies of the Phase 3 Clarity AD open-label extension trial in individuals with early AD. Data shows that transitioning to the weekly LEQEMBI IQLIK after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued intravenous (IV) dosing. The safety profile of the subcutaneous treatment was similar to that of the IV maintenance treatment with one key difference: systemic reactions (symptoms such as headache, fever, or fatigue) were much less common with subcutaneous dosing—less than 1% compared to approximately 26% with IV infusions.

Separately, the FDA recommended additional, earlier MRI monitoring for patients with Alzheimer’s disease taking LEQEMBI IV infusion. Earlier monitoring may help clinicians identify patients experiencing brain swelling or fluid buildup and help inform treatment decision-making. The MRI monitoring section of the prescribing information regarding the initiation phase of LEQEMBI IV has been updated.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Senate Appropriations Committee rejects President’s budget proposal and approves bill to support key AD/ADRD Programs

By a bipartisan vote of 26-3, the Senate Appropriations Committee has approved the proposed Labor, Health, and Human Services (LHHS) appropriations bill for FY2026 (see also the accompanying report language). The bill rejects the President’s harmful proposal to defund and dismantle programs across the Department of Health and Human Services (HHS), including those supporting essential Alzheimer’s disease and related disorders (AD/ADRD) activities. Instead, this bipartisan bill provides a $100 million increase over FY2025 levels to $3.9 billion for AD/ADRD research at the National Institutes of Health (NIH), $41.5 million for AD/ADRD work at the Centers for Disease Control and Prevention (CDC), and $31.5 million for the Administration for Community Living (ACL) Alzheimer’s Disease Program.

Among other AD/ADRD-related work, the bill encourages the NIH to improve diagnostic tests for neurodegenerative diseases, expand research into metabolic interventions, assess risk factors related to cognitive impairment, prioritize funding scientifically-based early interventions for dementia, and report on activities related to Alzheimer’s global cohort studies; encourages CDC to increase capacity to support populations with a high burden of Alzheimer’s and other dementias through public health promotion and workforce development; urges the Centers for Medicare and Medicaid Services (CMS) to reconsider Medicare’s National Coverage Determination policy for FDA-approved Alzheimer’s disease therapies; and encourages the Health Research and Services Administration (HRSA) to continue utilizing the ADRD screening measure reporting requirement to promote increased access to cognitive assessments across the Health Center Program.

To address dangerous actions of the current administration, the bill also calls for the HHS Secretary to submit a detailed plan and justification prior to initiating a reorganization or transfer of functions carried out by CDC, and urges the NIH to submit a detailed report and analysis on its multi-year funding approach policies.

Importantly, levels and initiatives proposed within this bill are subject to change as both chambers of Congress will need to engage in negotiations to develop a final bill. Currently, the House is in recess, and there are active discussions in the Senate about when they may depart for their August recess. Both the House and the Senate are expected to resume negotiations on FY2026 funding after the House LHHS bill is marked up by the subcommittee on September 2 (watch livestream), followed by a full committee markup on September 9.

Senate legislation introduced to strengthen long-term care ombudsman program

Senators Tim Kaine (D-VA) and Andy Kim (D-NJ) have introduced the Strengthening Advocacy for Long-Term Care Residents Act (S. 2490), legislation to improve the Long-Term Care Ombudsman program established under the Older Americans Act. Local Ombudsman programs designate staff and trained volunteers to advocate for residents of nursing homes and other long-term care (LTC) facilities, allowing residents and their families to report poor conditions and access confidential information related to their health and safety. With an increasing number of older Americans residing in LTC facilities, the program struggles to meet the needs of LTC residents under existing policies. The legislation would: 

• Instruct the Administration for Community Living (ACL) to establish categories of duties for volunteers and appropriate training requirements for volunteers based on those categories. Training guidelines should reflect the diversity of volunteer contributions to the Ombudsman program. This will make it easier to recruit and retain more Ombudsman program volunteers and continue to ensure volunteers have appropriate training.
• Reaffirm Congress’ intent that the Ombudsman program should be led by a full-time National Director. In 2019, a reorganization at the ACL resulted in the loss of this position. State and local ombudsmen have reported that the lack of a full-time National Director impedes coordination and distracts from the mission of the program.
• Require the National Academies of Sciences, Engineering and Medicine (NASEM) to study and issue a report on the effectiveness of the LTC Ombudsman program, including a recommendation for the number of ombudsmen per LTC facility bed. This would give states and the ACL better insight into the current needs of the program. In 1995, the Institute of Medicine (now part of NASEM) released a report recommending a staffing ratio of one ombudsman per 2,000 beds for the Ombudsman program. This staffing ratio has not been updated in the intervening three decades.

MedPAC publishes annual Data Book

The Medicare Payment Advisory Commission (MedPAC) recently published a brief titled “A Data Book: Health Care Spending and the Medicare Program.” The Data Book provides information on national health care and Medicare spending as well as Medicare beneficiary demographics, dually eligible beneficiaries, quality of care in the Medicare program, and Medicare beneficiary and other payer liability. The Data Book also examines provider settings, such as hospitals and post-acute care, and presents data on Medicare spending, beneficiaries’ access to care in the setting (measured by the number of beneficiaries using the service, number of providers, volume of services, length of stay, or through direct surveys), and the sector’s Medicare profit margins, if applicable. In addition, the Data Book covers the Medicare Advantage program and prescription drug coverage for Medicare beneficiaries, including Part D.

ASTHO issues report on supporting brain health and caregiving

The Association of State and Territorial Health Officials (ASTHO) published a new report, “From Policy to Practice: Supporting Brain Health and Caregiving at the State Level,” that explores promising policies, models, and strategies to strengthen caregiving systems and improve cognitive health outcomes. By examining recent legislation and innovative practices, the report provides actionable recommendations in key areas, including:

• Supporting a skilled workforce
• Educating the public
• Fostering partnerships and collaboration
• Strengthening data collection and utilization
• Coordinated state planning
• Funding and reimbursement mechanisms

Health agencies, as well as their partners, can adapt and scale these strategies to advance their Healthy Brain Initiative Road Map actions and increase their public health impact.

LuMind IDSC releases training for researchers to include people with Down syndrome 

As more people with Down syndrome (DS) participate in research and barriers to inclusion fall, clinical trial sponsors will need additional study teams and sites equipped to welcome and support them and their families. To meet this need, the LuMind IDSC Foundation has developed MinDSet™—a 60-minute, on-demand training for experienced research teams new to working with people with DS. The course offers practical guidance and instantly available tools, including a scientific overview of DS, common physical and behavioral traits, strategies for building trust, and procedure videos (MRI, PET, lumbar puncture) showing how to ensure participant comfort and successful procedures. MinDSet™ helps study teams prepare to conduct inclusive, person-centered research with the DS community. For more information about the MinDSet™ training program, please contact Lois Kelly.

ADvancing States issue brief explains the HCBS Quality Measure Set

ADvancing States, in collaboration with the Rehabilitation Research and Training Center on Home and Community-based Services at Shirley Ryan AbilityLab, has produced a new issue brief, “The HCBS Quality Measure Set: An Introduction.” The brief provides an overview of the Home and Community-based Services (HCBS) Quality Measure Set (QMS), developed by the U.S. Centers for Medicare & Medicaid Services (CMS) to improve the quality and accountability of Medicaid-funded HCBS. The brief discusses the growing need for long-term services and supports, the development of the QMS, and reporting requirements under the Ensuring Access to Medicaid Services (Access Rule) final rule. It also outlines the quantitative and qualitative measures in the QMS, how states are expected to use the tool, and CMS’s plans to refine the HCBS QMS for 2028.

Bio-Hermes-001 study Alzheimer’s disease dataset available to the public

The Global Alzheimer’s Platform Foundation® (GAP) and the Alzheimer’s Disease Data Initiative (AD Data Initiative) recently announced that data generated from the Bio-Hermes-001 study are publicly available. The Bio-Hermes-001 study produced the most extensively characterized cohort in Alzheimer’s disease to date, creating opportunities for new research and diagnostics with the data being available on the Alzheimer’s Disease Data Initiative’s AD Workbench. The Bio-Hermes-001 dataset represents over 80,000 blood and digital test results and is the most comprehensive set of dementia biomarker data from studies for Alzheimer’s disease. Bio-Hermes compared the performance of dozens of blood tests, digital cognitive tests, retinal exams, and speech analysis with traditional methods of measuring cognition and PET images, and enrolled an unprecedented number of cognitively, racially, and ethnically diverse participants, with 24% of participants representing traditionally understudied communities and reflecting people who range from cognitively normal, having mild cognitive impairment, or having mild dementia due to Alzheimer’s disease.

UsAgainstAlzheimer’s launches Clinical Trial Connector

UsAgainstAlzheimer’s recently launched the BrainGuide Clinical Trial Connector, a free, confidential tool developed in partnership with Carebox. This new resource helps individuals, caregivers, and healthcare providers more easily find and connect with clinical trials for Alzheimer’s disease and related dementias (AD/ADRD). At a time when participation in AD/ADRD trials remain low, this tool seeks to make it easier for people to take part in research that could lead to better treatments and care. For too long, patients have struggled to find relevant trials, and lengthy enrollment periods have delayed studies for months or years. Such delays disproportionately affect women and communities of color, who remain underrepresented in research. This confidential platform educes barriers to participation and promotes diverse representation in research.

AARP and NAC release 2025 “Caregiving in the US” report

AARP and the National Alliance for Caregiving have released the 2025 edition of “Caregiving in the US.” The report includes the latest data on the landscape of family caregiving. The report focuses on the experiences, living situations, and needs of the 63 million family caregivers of adults. There is a growing demand for family caregivers who provide support to those with chronic, disabling, or serious health conditions. The report outlines policy areas, workplace protections, and access to services. The report’s key findings include: 

• Demographics: One in every four adults is a caregiver. Of these, 94% care for adults, and one in three is under age 50. Caregivers are increasingly diverse across race, income, and generation. 29% are sandwich generation caregivers, supporting both children and adults. 
• Intensity and Complexity: Over 40% of caregivers now provide high-intensity care. Many perform complex medical tasks like administering injections or managing equipment, yet only 22% receive training. 
• Health and Financial Strain: One in five caregivers report poor health; a quarter are taking on debt due to caregiving. Half report negative financial impact due to caregiving, and one in five cannot afford basic needs like food. 
• Workplace Impact: Seven in ten family caregivers are employed, but many face disruptions and lack access to supportive benefits, especially the 18 million hourly wage workers. 
• Paid Caregivers: For the first time, the report includes 11 million caregivers who receive some compensation through Medicaid, VA, or other state programs. These caregivers are more likely to be younger, lower-income, and from diverse backgrounds. 

Additional Reads

• Utah high court pauses firing squad execution of man with dementia (read here)
• Blood P-tau217’s New Frontiers: Primary Care, Test-at-Home (read here)
• The gut immune system is altered in mouse model of Alzheimer’s, providing a new target for therapeutics (read here)
• Association of plasma Alzheimer’s disease biomarkers with cognitive decline in cognitively unimpaired individuals (read here)
• The Worst Piece of Health Care Legislation Ever (read here)
• The brain’s activity at rest may provide clues to Alzheimer’s disease progression, diagnosis (read here)
• The National Dementia Workforce Study: Perspective From the National Institute on Aging (read here)
• Digital Cognitive Tests: How AI Tools Could Transform Alzheimer’s Diagnosis and Care (read here)
• Key protein complex drives nerve cell death in Alzheimer’s disease, study finds (read here)
• Could routine eye exams reveal early signs of Alzheimer’s? (read here)
• Managing Alzheimer’s and Dementia: Patterns in Primary Care (read here)
• Novel Enzyme Activator Discovered as Potential Alzheimer’s Disease Therapy (read here)
• Coming Soon: Africa’s First Large-Scale Alzheimer’s Datasets (read here)
• Having a sense of purpose may protect against dementia (read here)
• Cardiovascular contributions to dementia: Examining sex differences and female‐specific factors (read here)
• Communication between tau and amyloid-β proteins found to mitigate Alzheimer’s toxicity (read here)
• Cold Sore Virus Concept for Alzheimer’s Takes a Hit in Drug Trial (read here)
• Interplay of genetic predisposition, plasma metabolome and Mediterranean diet in dementia risk and cognitive function (read here)
• Amyloid PET Imaging Improves Clinical Management in Dementia Care (read here)
• Metabolic syndrome and risk of incident all-cause dementia, Alzheimer’s disease and vascular dementia: a systematic review and meta-analysis of longitudinal studies (read here)
• Therapeutic Implications of Allopregnanolone in Alzheimer’s Related Depression (read here)
• Real-World Experience With Antiamyloid Therapies for Alzheimer Disease (read here)
• Roche Spells Out Phase Three Plans for Trontinemab (read here)
• Potential stroke and dementia therapies, along with oral health discoveries, put on hold at UCLA (read here)
• Symptoms to Symphonies: Composer İdil Özkan on Music, Memory, and Loss (read here)
• How a Gift Card Could Help Speed Up Alzheimer’s Clinical Research (read here)
• Pitt Study Finds No Significant Link Between ECAC and Alzheimer’s Disease Biomarkers (read here)
• Researchers uncover hemoglobin’s antioxidant role in brain cells and boost it to fight ALS, Parkinson’s, Alzheimer’s, aging, and autoimmune disorders (read here)
• Supreme Court Lets Trump Administration Cut N.I.H. Grants for Disfavored Research (read here)
• Epilepsy and Dementia: Studying the Hidden Role of Seizures (read here)
• CDC finalizes roughly 600 layoffs; union says workforce ‘decimated’ (read here)
• Midkine protein plays a preventive role against Alzheimer’s disease (read here)
• Brain’s Blood Flow Could Change How We Understand and Treat Alzheimer’s (read here)
• Senate Labor-HHS Funding Bill a Rebuke to Trump’s Budget Proposal, Experts Say (read here)
• ABCA7 deletion lowers age at onset of Alzheimer’s disease and interacts with APOE ε4 synergistically in African‐ancestry populations (read here)
• Exploring the effect of pre-clinical Alzheimer’s disease on blood pressure using Mendelian randomisation and parental dementia as an instrumental variable in UK Biobank (read here)
• A smart secure virtual reality immersive application for alzheimer’s and dementia patients (read here)
• This Protein Slows the Aging Brain, and We Know How to Counter It (read here)
• Omega-3’s could protect women against Alzheimer’s (read here)
• Advancing Care in Alzheimer’s Disease: Current Treatments and Their Impact on Quality of Life (read here)
• Sleep regularity is associated with cognitive function and shows an inverted U-shaped relationship with serum brain-derived neurotrophic factor (read here)
• Dementia’s Link With Hearing Loss May Start Sooner Than We Think (read here)
• Forget PET and CSF. Start Immunotherapy on a Blood Test? (read here)
• Blood-Based Biomarker Guidelines for Alzheimer Disease Diagnosis (read here)
• Vascular Contributions to Cognitive Impairment and Dementia in the United States: Prevalence and Incidence: A Scientific Statement From the American Heart Association (read here)
• Listen to the music: How – and when – emotional responses to music influence memory (read here)
• The unexpected medication that could revolutionize the treatment of Alzheimer’s disease (read here)
• Metformin Use Linked to Lower Risk for Dementia, Death in Adults With Overweight, Obesity (read here)
• The Dementia Disparity: Rethinking Alzheimer’s Through The Female Lens (read here)
• Dementia: Exploring the Neuropathology of Hyperactive and Psychotic Symptoms (read here)
• Why do some people age faster than others? Study IDs genes at play (read here)
• Blood phosphorylated tau for the diagnosis of Alzheimer’s disease: a systematic review and meta-analysis  (read here)
• NIH chief calls for immediate research review, dangling threat of project termination (read here)
• Clinicians Who Practice Primarily in Nursing Homes and Quality of Care for Residents With ADRD (read here)
• Insights into Smelling Problems Associated with Alzheimer’s (read here)
• An unexpected link between pancreatic cancer and dementia could help us beat the disease (read here)
• Mitochondrial move-in: Could relocating proteins help diagnose Alzheimer’s? (read here)
• NIH Funding Roller Coaster: The Ride Isn’t Over (read here)
• New high blood pressure guideline emphasizes prevention, early treatment to reduce CVD risk (read here)
• Inside the Lab Studying Why Women Face Greater Alzheimer’s Risk  (read here)
• Microtuble-Binding Region—the Next Marker for Immunoassay Platforms? (read here)
• Alzheimer’s Disease Pathology and Potential Treatment Targets Identified in Brain Organoids (read here)
• Linking Alzheimer’s biomarkers to cognitive decline (read here)
• Ultrasensitive platform detects Alzheimer’s biomarkers in body fluids with high precision (read here)
• Dementia care and mortality in people experiencing homelessness: A matched cohort study (read here)
• Fewer Dementia Neuropsychiatric Symptoms With Hearing Aids (read here)
• Light therapy provides new hope for Alzheimer’s patients (read here)
• Women with Down syndrome may develop Alzheimer’s disease more rapidly than men (read here)
• First Morsel of Results from DIAN Concurrent Amyloid and Tau Trial (read here)
• Cats with dementia share hallmarks of Alzheimer’s (read here)
• Decoding memory function through naturalistic gaze patterns (read here)
• AI-driven fusion of multimodal data for Alzheimer’s disease biomarker assessment (read here)
• The Dawn of a New Era in Alzheimer’s and Parkinson’s Treatment (read here)
• Antiparasitic Drug Shows Power Against Alzheimer’s and Dementia (read here)
• New AI Tool to Predict Markers of Alzheimer’s Disease (read here)
• Alzheimer’s Disease: The Complexities of Clinical Trials (read here)
• More women get Alzheimer’s than men. It may not just be because they live longer (read here)
• Importance of Patient Selection and Future Therapies in Alzheimer Treatment (read here)
• Top Tips for Understanding the Dementia Side of Interactions  (read here)
• Early Locus Coeruleus noradrenergic axon loss drives olfactory dysfunction in Alzheimer’s disease (read here)
• Enhancing the validity of CAIDE dementia risk scores with resting heart rate and machine learning: An analysis from the National Alzheimer’s Coordinating Center across all races/ethnicities (read here)
• Your lifestyle could be affecting your brain’s ‘brake system’ and putting you at a higher risk of dementia (read here)
• Multimodal Alzheimer’s disease recognition from image, text and audio (read here)
• Toward compassionate communication: a rapid review on facilitating the dementia disclosure process (read here)
• ‘A tipping point’: An update from the frontiers of Alzheimer’s disease research (read here)
• Will Keeping HDLs Lipidated Also Keep Alzheimer’s Away? (read here)
• ‘Life’s Not Over—Just Different’ 10 Years With Early-Onset Alzheimer’s (read here) 
• Neighbourhoods may hold the key to slowing cognitive decline (read here)
• The first 25 years of SuperAger research show cognitive decline is not an inevitable part of aging (read here)
• Strengthening Africa’s brain health and economic resilience (read here)
• An integrated view of the relationships between amyloid, tau, and inflammatory pathophysiology in Alzheimer’s disease (read here)
• New Multiomic Atlas To Decode the Brain’s Blood Vessels (read here)
• UC Irvine researchers find combination of natural compounds for brain cleaning (read here)
• Altered Cholesterol Uptake by Neurons in Alzheimer’s Disease Linked to APOE4 Variant (read here)
• Lithium deficiency and the onset of Alzheimer’s disease (read here)
• Trump Administration Illegally Withheld N.I.H. Funding, Watchdog Finds (read here)
• RFK Jr. may be on the verge of dismantling U.S. preventive health care (read here)
• ‘Virtual’ socialization greatly eases isolation in older adults with dementia (read here) 
• Experiments Add to Evidence of Links Between Amyloid Deposits in Brain and Bone Marrow (read here)
• Preclinical Study: Enzyme Could Help Treat Alzheimer’s Disease (read here)
• Mitochondrial dysfunction linked to Alzheimer’s onset and treatment response (read here) 
• Is dirty air driving up dementia rates? (read here)
• Exposure to nanoplastics could induce spread of Alzheimer’s disease from the brain to other other organs (read here)
• Fasting is required for many of the benefits of calorie restriction in the 3xTg mouse model of Alzheimer’s disease (read here)
• Lifetime Dementia Risk Highest Among Women, Black Adults, APOE ε4 Carriers (read here)
• Tau PET Positivity Varies by Age, Genetics, and Sex (read here)
• Phase 3 Study Results of Obicetrapib on Alzheimer Disease Biomarker Progression: Philip Scheltens, MD, PhD (read here)
• Single-cell multiregion epigenomic rewiring in Alzheimer’s disease progression and cognitive resilience (read here)
• Common Questions About the FDA-Approved Alzheimer’s Blood Test (read here)

July, 2025 News

LEAD Coalition submits FY 2026 Appropriations letter to Congress

The LEAD Coalition has submitted its FY 2026 appropriations letter to Congress. The letter, signed by 481 LEAD Coalition member organizations and allies, urges Congress to reassert our country’s non-partisan national priority to overcome Alzheimer’s disease and related disorders (AD/ADRD) by:

• making robust appropriations for federal agencies to meet the National Alzheimer’s Project Act (NAPA) goals and ensuring expenditure of those funds is completed in a full and timely manner for the Congressionally-designated purposes
• guaranteeing that the work of civil servants, research institutions, clinicians, and social service providers is not disrupted
• reauthorizing essential laws.

LEAD Coalition member and allied organizations are encouraged to use the letter to support their efforts to educate Congress and the public about the urgency to continue the momentum toward the National Alzheimer’s Plan goals and your own commitment to advancing science, care and support, and public health. 

House Appropriations Committee announces interim 302(b) allocations to subcommittees 

The House Appropriations Committee has issued updated fiscal year (FY) 2026 appropriations subcommittee allocations. The allocations — known as “302(b)s” —  inform each subcommittee of the maximum funding it can provide the agencies and programs within its authority. The top-line allocation for non-defense discretionary spending has been set at $705.6 billion and would constitute a roughly six percent cut compared to FY 2025. The 302(b) allocation for the Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations subcommittee, which provides discretionary funding for the entirety of the Department of Health and Human Services except for the Food and Drug Administration, is $184.49 billion. This would cap the subcommittee’s FY 2026 appropriations bill at approximately $1.3 billion less than the amount it appropriated in its FY 2025 Labor-HHS bill. The subcommittee does have the power to make steeper cuts below the $184,49 billion ceiling. 

In a related development, it now appears likely that the House Labor-HHS appropriations subcommittee will not mark up its spending bill at least until September, a substantial delay from the originally announced schedule in which the subcommittee planned to mark up the bill on July 21, followed by a full committee mark up on July 24 (see the schedule). The new House timeframe considerably increases the risk of a continuing resolution being necessary to avert a partial federal government shutdown on October 1, which is the first day of the fiscal year. The Senate Appropriations Committee has noticed that there will be a full committee markup of the Labor-H bill on July 31 at 9:30 a.m. ET. The markup will be held in 106 Dirksen Senate Office Building and will be livestreamed here.

14 Senate Republicans press OMB to disburse all appropriated FY 2025 funds for NIH

Senator Katie Britt (R-AL) and 13 fellow Republican Senators sent a July 24 letter to Office of Management and Budget (OMB) Director Russell Vought calling for the full implementation of the “Fiscal Year (FY) 2025 Full-Year Continuing Appropriations and Extensions Act, including funds appropriated for the National Institutes of Health (NIH).” The letter notes that the “continuing resolution supports NIH initiatives across a range of critical research areas – cancer, cardiovascular disease, rare pediatric disorders, and more.” The letter continues, noting that the Senators share the goal to restore public trust in the NIH but “Withholding or suspending these funds would jeopardize that trust and hinder progress on critical health challenges facing our nation.”  

CBO analysis determines that funding cuts to NIH and FDA will lead to fewer drugs coming to market

The non-partisan Congressional Budget Office (CBO) has analyzed the effects of a potential 10% reduction in NIH funding and a nine-month increase in FDA review times of new drug applications. The analysis found that these proposed changes could have significant effects on the drug development pipeline. (See the full analysis and a summary.)

Using a simulation model, CBO projected that a permanent 10% reduction in NIH funding would decrease the number of new drug candidates available for testing in clinical trials by roughly 4.5%. This effect would unfold over decades and lead to fewer drugs eventually entering the market. More specifically, CBO estimated that one (1) less drug would be introduced in the first decade after the implementation of the funding reductions, nine (9) fewer drugs in the second decade, and 20 fewer by the third decade. CBO also acknowledged that NIH funding reductions would decrease the number of NIH-funded clinical trials in which these drug candidates could be tested. Though unable to calculate the magnitude, CBO noted that reduced funding for clinical trials, especially late-phase trials, would create effects realized more immediately than cuts to preclinical research.

CBO also projected that a nine-month increase in FDA review timelines automatically would delay drug approvals – and thus entries into the market – and would increase the cost of developing new drugs. Increased costs would deter the number of drug approvals sought over time; specifically, CBO estimated that three (3) fewer drugs would enter the market in the first decade after delayed FDA review timelines and 10 fewer drugs would reach market in both the second and third decades. Taken together, delayed review timelines would be associated with a 2% decrease in the number of new drugs coming to market over time.

CBO acknowledged that proposed funding cuts and delays in review could lead to several other effects that are currently unknown or unable to be quantified. Importantly, the 10% reduction in NIH funding is a mere quarter of the cuts proposed in the FY 2026 President’s Budget.  If Congress cuts NIH funding at the President’s budget level (a nearly 40% reduction), these effects would increase exponentially.

FDA approves Kisunla label update with new titration dosing schedule

The U.S. Food and Drug Administration (FDA) has approved a label update for Kinsunla (donanemab-azbt), Lilly’s amyloid-targeting therapy for individuals with early symptomatic Alzheimer’s disease, with confirmed amyloid pathology. The label update includes a new recommended titration dosing schedule based on findings from the TRAILBLAZER-ALZ 6 study. The results of this recent Phase 3b study (NCT05738486) showed that modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. For more information, visit the FDA Safety-Related Labeling Changes update or the Lilly press release.

NIH issues guidance to discourage use of AI in investigator applications and restrict PIs to six applications per year

The National Institutes of Health (NIH) has issued new policy guidance, “Supporting Fairness and Originality in NIH Research Applications,” regarding use of Artificial Intelligence (AI) in investigator applications and the total number of applications investigators may submit. There is no evidence that NIH sought any public comment or input from Congressional committees of jurisdiction on this new policy prior to its implementation.

Per this new policy, NIH will not consider applications identified as having been developed substantially by AI. Problematically, the new policy neither defines “substantial” use of AI nor describes the AI detection tools that NIH will utilize. Furthermore, the policy details that if an application is successfully reviewed and awarded, and AI-generated content is detected post-award, the NIH Office of Research Integrity will initiate an investigation into research misconduct. The lack of detail in this new policy leaves many unanswered questions, including any basis upon which NIH determined the need for such a new policy and a process for resubmission and/or appeal for investigators whose applications may be flagged in error. 

As a second component of this new policy, the NIH is limiting the number of applications considered from an investigator per calendar year. As of September 25, 2025, the NIH will accept only six (6) new, renewal, resubmission, or revision applications from an individual Principal Investigator/Program Director or Multiple Principal Investigator for all council rounds in a calendar year. This limit applies across all grant activity codes except for certain training grants (T) and conference (R13) grants. The NIH policy  leaves unclear how such limitations actually will deter the use of AI tools – though such limitations likely will discourage investigators from applying with new, innovative ideas and cause  reduced opportunities for scientific collaboration.

Taken together, the aspects of this new policy are likely to result in fewer applications to NIH and thus skew NIH success rates for FY2026 and beyond (i.e., the total number of applications, or the denominator, will be lower than previous fiscal years). Such an approach could allow the administration to make drastic cuts to the number of funded awards while claiming little to no change in success rates and budgets for programs.

LEAD Coalition welcomes new member organizations

The LEAD Coalition recently welcomed Neurogen Biomarking and Cure MAPT FTD as its newest member organizations.

Neurogen Biomarking supports the early detection of Alzheimer’s disease with a seamless process that includes easy-to-use at-home testing and access to world-class neurologists, enabling more people to receive better care and achieve better outcomes. The team consists of clinical neurologists, leading scientific researchers, and healthcare entrepreneurs, united by a mission to make high-quality, early Alzheimer’s detection and care accessible to all. The team has witnessed firsthand the urgent need to improve the Alzheimer’s care journey. That’s why the team built an integrated ecosystem – bringing advanced biomarker testing, remote cognitive assessment, and expert clinical guidance directly to people concerned about their cognition.

Cure MAPT FTD is a global patient advocacy organization focused on finding a cure for a MAPT-gene mutations; this results in frontotemporal dementia (FTD), with disease onset typically in one’s 40s and 50s. Cure MAPT FTD unites families, researchers, and advocates worldwide to push for a disease-modifying solution. This tauopathy has yet to have a single medical trial, so by demonstrating this disease is severely undercounted, Cure MAPT FTD hopes to convince researchers, pharmaceutical executives, and governmental bodies to green-light these potentially life-saving trials and expand labeling for the tau-related medications emerging onto the marketplace. 

MedPAC issues annual report to Congress

The Medicare Payment Advisory Commission (MedPAC) has released its annual Report to Congress, outlining improvements to Medicare payment systems and issues affecting the Medicare program, including changes to health care delivery and the market for health care services. The seven chapters of the 2025 report cover the following topics:

• Reforming physician fee schedule updates and improving the accuracy of relative payment rates. The Commission recommends replacing the current-law updates to fee-for-service (FFS) Medicare’s physician fee schedule (PFS) with an annual update based on a portion of the growth in inflation, as measured by the Medicare Economic Index (MEI). The Commission also recommends that the relative accuracy of PFS payment rates be improved by collecting and using timely data that better reflect the relative costs of delivering care.
• Supplemental benefits in Medicare Advantage. The Commission reviews trends in Medicare’s spending for Medicare Advantage (MA) supplemental benefits, summarizes the types of supplemental benefits offered by MA plans, and assesses the potential utility of MA encounter data for measuring enrollees’ use of these benefits.
• Examining home health care use among Medicare Advantage enrollees. Using a combined dataset of the encounter and home health assessment data, the Commission assesses use of home health care by MA enrollees.
• Part D prescription drug plans for beneficiaries in fee-for-service Medicare and Medicare Advantage. The Commission describes how MA and Part D policies and other factors may be affecting trends in plan offerings and relative costs and payments for stand-alone prescription drug plans (PDPs) and MA Prescription Drug plans (MA–PDs).
• Medicare beneficiaries in nursing homes. The Commission describes the Medicare long-stay nursing home (NH) population and reviews regulations and programs that CMS has implemented to improve NH quality, including specialized MA plans known as institutional special-needs plans.
• Medicare’s measurement of rural provider quality. The Commission reviews the inclusion of rural providers in current Medicare FFS quality-reporting programs.
• Reducing beneficiary cost sharing for outpatient services at critical access hospitals. The Commission recommends that FFS beneficiary cost sharing for outpatient services provided at critical access hospitals be based on each hospital’s Medicare payment amount instead of on the hospital’s charges.

Excel files of the data underlying the figures in the chapters of this publication are available for download. Excel files are provided only when the data are not otherwise shown or labeled in the chapter. 

NIH publishes 2025-2030 Strategic Plan for Data Science

The National Institutes of Health (NIH) has published the 2025-2030 Strategic Plan for Data Science. Highlights of the plan include increased support for the NIH Data Management and Sharing Policy, noting new tools and processes are forthcoming; new suggested methods for collecting informed consent when combining data from multiple sources; enhanced support for community-developed software tools with better visualization capabilities; progress towards a federated data ecosystem where researchers can more easily connect disparate datasets across platforms; and increased data science training opportunities. This strategic plan builds on significant progress made since the first Data Science Strategic Plan, with a renewed focus on partnership, capacity-building, and responsible innovation. 

ACL grants strengthen state No Wrong Door systems

The Administration for Community Living (ACL) Office of Network Advancement has awarded 12 new grants through the Enhancing State No Wrong Door Systems for Efficient Access to Long-Term Services and Supports funding opportunity. The grantees are the California Department of Aging, the Maryland Department of Aging, the Massachusetts Executive Office of Aging & Independence, the Michigan Department of Health & Human Services, the Curators of the University of Missouri, the University of North Carolina at Asheville, the Rhode Island Office of Healthy Aging, Texas Health and Human Services, the University of Utah, the Vermont Aging Network Consortium, Inc., the Virginia Department for Aging and Rehabilitative Services, and the Wisconsin Department of Health Services.

These two-year grants will strengthen state No Wrong Door (NWD) System infrastructure to make it easier for individuals in need of long-term services and supports (LTSS) to connect to existing community resources. NWD transforms the way people access services in the community to support their health, well-being, and independence. Enabled by state-led, cross-agency initiatives, NWD makes it easier for people of all ages, abilities, and incomes to get the services they need. This funding will support state efforts to modernize access to LTSS through their NWD System. Projects funded through this opportunity will focus on at least one of the four core NWD functions:

• State governance and administration
• Public outreach and coordination with key referral sources
• Person-centered counseling
• Streamlined eligibility to public programs

Grantee activities include aligning NWD goals with state multi-sector plans on aging, establishing or strengthening governance committees, modernizing information technology systems, expanding community partnerships, and strengthening the NWD workforce.

Additional Reads

• Global dementia research must reflect global diversity (read here)
• Food Security As A Brain Protector? Study Links SNAP To Lower Dementia Risk (read here)
• Dementia’s broad reach: More than 1 in 4 families of older adults at risk for providing care (read here)
• Alzheimer’s Association Clinical Practice Guideline on the use of blood‐based biomarkers in the diagnostic workup of suspected Alzheimer’s disease within specialized care settings (read here)
• Demographic Data Supporting FDA Authorization of AI Devices for Alzheimer Disease and Related Dementias (read here)
• Major Alzheimer’s group says some blood tests may be used in place of brain scans for diagnosis (read here)
• Care beyond kin: U-M study urges rethink as nontraditional caregivers step up in dementia care (read here)
• Antiviral Treatment Fails to Slow Early-Stage Alzheimer’s (read here)
• Nature-Inspired Virtual Reality Boosts Emotional Well-Being In Older Adults Living With Dementia (read here)
• What the U.S. POINTER results mean for public health initiatives and the Alzheimer’s Association (read here)
• Structured vs Self-Guided Multidomain Lifestyle Interventions for Global Cognitive Function: The US POINTER Randomized Clinical Trial (read here)
• Worried about Alzheimer’s? Start walking, according to a new 10-year study (read here)
• When Caveolin Ferries Fibrinogen Into the Brain, CAA Gets Worse (read here)
• How Existing Cardiovascular Drugs Could Slow Cognitive Decline (read here)
• These Immune Cells Eat Molecular Trash to Keep Alzheimer’s at Bay (read here)
• Blood Vessels and Immune Cells Drive Risk for Alzheimer’s and Stroke (read here)
• Older Adults Taking Heart Disease, Diabetes Meds Have Slower Rates of Cognitive Decline (read here)
• How is artificial intelligence helping to diagnose dementia? (read here)
• Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer’s disease (read here)
• Tau, atrophy, and domain-specific cognitive impairment in typical Alzheimer’s disease (read here)
• Dementia Risk Among US Veterans Varies Significantly by Region (read here)
• Predicting mortality risk in Alzheimer’s disease using machine learning based on lifestyle and physical activity (read here)
• Long-term exposure to outdoor air pollution linked to increased risk of dementia (read here)
• Europe Needs More Alzheimer’s Treatments – Now (read here)
• Math Model Sheds Light On Alzheimer’s Spread (read here)
• Meta-Analysis Finds Apathy Highly Prevalent Across Lewy Body Dementia Spectrum (read here)
• Sleep disruption damages blood vessels in brain and may increase dementia risk: study (read here)
• Big Data Insights: Blood Signatures of Cognitive Decline, Aging, APOE4 (read here)
• Why So Many Seniors Can’t Afford Long-Term Care (read here)
• New Study Validates Insulin Nasal Spray to Deliver Alzheimer’s Drug Directly to the Brain (read here)
• GLP-1 diabetes drugs likely trump metformin for curbing dementia risk in type 2 diabetes (read here)
• Defendants living with dementia face challenges in justice system (read here)
• Inflammatory bowel disease possibly accelerates dementia (read here)
• Breakthroughs Changing The Diagnosis And Treatment Of Alzheimer’s (read here)
• Blood plasma reveals shared pathways in neurodegenerative diseases (read here)
• Could the Brain Be the Real Fountain of Youth? (read here)
• What Can Spiders Tell Us About Alzheimer’s Disease? (read here)
• Cell-type-directed network-correcting combination therapy for Alzheimer’s disease (read here)
• Do These Two Cancer Drugs Have What It Takes to Beat Alzheimer’s? (read here)
• ‘A disaster for all of us’: US scientists describe impact of Trump cuts (read here)
• Structural and social determinants of dementia risk among adults racialized as Black: Results from a community‐based system dynamics approach (read here)
• Seniors face widening care gaps after dementia diagnoses, major study reveals (read here)
• Purdue Researchers Develop a Novel Human Brain Model to Study Alzheimer’s Disease (read here)
• Nearly 4 in 10 extended families of older adults in the United States include an older relative with dementia (read here)
• Dementia With Lewy Bodies: What You Need to Know (read here)
• AI can accelerate search for more effective Alzheimer’s medicines by streamlining clinical trials (read here)
• New Database Could Speed Up Alzheimer’s, Parkinson’s Research (read here)
• Music may reduce distress for dementia patients (read here)
• Deafness and loneliness pave the way for dementia (read here)
• Large Tau-PET Studies Confirm: Tangles Foretell Decline (read here)
• Caring for a loved one with dementia is hard. Financial planning can alleviate the stress. (read here)
• Global collaboration is key to decoding Alzheimer’s disease (read here)
• Long-term musical training can protect against age-related upregulation of neural activity in speech-in-noise perception (read here)
• Six-hour ‘undo’ button: GAI-17 rewinds stroke damage and may beat Alzheimer’s (read here)
• Using HIV Drugs to Fight Alzheimer’s (read here)
• Microglia discovery offers clues to Alzheimer’s progression (read here)
• Shared and disease-specific pathways in frontotemporal dementia and Alzheimer’s and Parkinson’s diseases (read here)
• NIH to dismiss dozens of grant reviewers to align with Trump priorities (read here)
• In Down’s Syndrome, Alzheimer’s Disease Has Unique Features (read here)
• Demystifying the Link Between Major Depression and Alzheimer’s Disease (read here)
• Brain biomarkers of Alzheimer’s disease can be detected as early as middle age (read here)
• Sleep, pericyte subtypes and cognitive decline in adults with and without Alzheimer’s disease (read here)
• IU-led Alzheimer’s drug discovery center moves forward with promising new therapeutic targets (read here)
• Older adults with dementia misjudge their financial skills – which may make them more vulnerable to fraud, new research finds (read here)
• What to know about the new Alzheimer’s blood test (read here)
• UCI MIND Investigators Identify Differences In Cognitive Decline Based On Alzheimer’s Genes (read here)
• David Gergen, consummate political insider, dies at 83 from complications of Lewy body dementia (read here)
• SARS-CoV-2 Causes Buildup of Alzheimer’s-Related Peptides in the Retina (read here)
• More misfolded proteins than previously known may contribute to Alzheimer’s and dementia (read here)
• Nerve pain drug gabapentin linked to increased dementia, cognitive impairment risks (read here)
• CTE and normal aging are difficult to distinguish, new study finds (read here)
• In Centenarians, More Amyloid Spells Poorer Cognition (read here)
• NIH director is replacing his top outside advisory board (read here)
• Over 400 different types of nerve cell have been grown – far more than ever before (read here)
• A Key Role of Brain Protein in Learning and Memory Is Deciphered by Scientists (read here)
• Uncovering ApoE3 Christchurch’s Multi-Pathway Defense Against Alzheimer’s (read here)
• Novel AI Method Sheds Light on how Enzyme Linked to Alzheimer’s Selects its Targets (read here)
• University of Maryland School of Medicine Launches Groundbreaking Study on THC/CBD Therapy for Dementia-Related Agitation at End of Life (read here)
• Discovery Could Battle Alzheimer’s by Boosting Blood Flow to Brain (read here)
• What to Know About the Collapse of the F.D.A.: The regulatory agency confronts a future determined by a health secretary hostile to its mission. (read here)
• Dementia and Alzheimer’s disease aren’t the same thing. Here’s why. (read here)
• Efficacy of music therapy as a non-pharmacological measure to support alzheimer’s disease patients: a systematic review (read here)
• People diagnosed with dementia are living longer, global study shows (read here)
• Dementia protection linked to where the body lies – belly fat a risk factor (read here)
• Vision Problems? Language Loss? It Could Still Be Alzheimer’s (read here)
• Group is investigating biomarkers for the early detection of Alzheimer’s disease (read here)
• Dementia Incidence and Prevalence: What’s Changing in Medicare Data? (read here)
• Why are women twice as likely to develop Alzheimer’s as men? (read here)
• Elderly people with dementia being subjected to violence, abuse and neglect in their own homes (read here)
• A New Blood Biomarker Predicts the Progression of Alzheimer’s Disease Even in Its Earliest Stages (read here)
• Regular Use of Strong Opioids May Lead to Increased Dementia Risk (read here)
• Using scores from the 4AT delirium detection tool as an indicator of possible dementia: a study of 75,221 older adult hospital admissions (read here)
• Where Axon Meets Myelin—Alzheimer’s Pathology? (read here)
• It’s never too late to start playing an instrument: Playing music may benefit memory in old age, study suggests (read here)
• Unravelling the plasma proteome: Pioneering biomarkers for differential dementia diagnosis (read here)
• Enhancing early detection of cognitive impairment in primary care with the TabCAT‐BHA (read here)
• SARS-CoV-2 induces Alzheimer’s disease–related amyloid-β pathology in ex vivo human retinal explants and retinal organoids (read here)
• Estimating the impact of risk factor reduction on dementia prevalence in New Zealand (read here)
• Why Do Some Brain Regions Resist Alzheimer’s? (read here)
• New study maps four key pathways to Alzheimer’s disease (read here)
• Hearing devices significantly improve social lives of those with hearing loss (read here)
• First Large-Scale Stem Cell Bank Enables Worldwide Studies on Genetic Risk for Alzheimer’s Disease (read here)
• Wider Availability of Alzheimer’s Blood Test Brings Reason for Hope and Need for Caution, Experts Say (read here)
• Shingles, RSV vaccines may protect older adults from dementia (read here)
• Caregiving Again? How Experience Transforms Your Next Journey (read here)
• Changes in the blood could protect against Alzheimer’s disease (read here)
• A genome-wide in vivo CRISPR activation screen identifies BACE1 as a therapeutic vulnerability of lung cancer brain metastasis (read here)
• We’ve Never Seen Health Care Cuts This Big (read here)
• Fueling the Brain: How Metabolism May Hold the Key to Alzheimer’s Prevention (read here)
• The Death of a Partner and Financial Stress Have Been Linked to an Increased Risk of Alzheimer’s Disease and Differences in Brain Structure (read here)
• How exercise can protect against Alzheimer’s (read here)

June, 2025 News

LEAD Coalition welcomes new federal policy director

The LEAD Coalition is pleased to announce the appointment of Dr. Courtney Wallin as its new Federal Policy Director, beginning on June 10.  In this role, Dr. Wallin will work alongside the Executive Director to build and leverage consensus on federal public policies relevant to Alzheimer’s disease and related causes of dementia. Dr. Wallin will contribute technical expertise to strategic conversations, forge relationships with LEAD Coalition member and allied organizations along with the scientific community, and develop messaging to effectively articulate policy positions to a broader audience. 

Dr. Wallin brings a wealth of leadership and experience to the LEAD Coalition. She joins the LEAD Coalition from the National Institutes of Health (NIH), where she most recently was the Director of the Office of Legislation, Policy, & International Activities at the National Institute on Aging (NIA). In this role, Dr. Wallin served as a liaison to Congress and other stakeholders and led a team responsible for developing high-impact products, such as the annual Alzheimer’s Disease Professional Judgment Budget and Scientific Progress Report. Dr. Wallin joined the NIH in 2016 as a Presidential Management Fellow, serving as a health science policy analyst within NIA. As a fellow, Dr. Wallin contributed to a range of projects and events, including organizing the inaugural National Dementia Care and Caregiving Research Summit in 2017, a groundbreaking event (first proposed by the LEAD Coalition) that has set the stage for national dialogue on dementia care and led to numerous NIH funding opportunities. Dr. Wallin also served as the Outreach Lead at NIH’s All of Us Research Program in 2020 and 2021, where she led efforts to raise awareness about the value of the All of Us dataset, engage researchers from a broad range of communities, and cultivate program partnerships.

Dr. Wallin earned her Ph.D. in Cognitive Neuroscience from The George Washington University. While pursuing her doctorate, Dr. Wallin was awarded the National Science Foundation Graduate Research Fellowship; she also received the Australian Endeavour Research Fellowship to support research training at the University of Wollongong in Australia. Dr. Wallin also holds undergraduate degrees in Biology and Psychology from Providence College. 

Administration releases updated details on radical FY 26 budget proposal

The Trump Administration has released the Fiscal Year 2026 (FY 26) Discretionary Budget Request technical supplement, a 1,215 page document containing various tables and schedules, explanations of the work to be performed and the money needed, language proposed for enactment by the Congress on each item that requires congressional action in an appropriations bill, and language proposed for the general provisions of appropriations Acts that apply to entire agencies or groups of agencies. The Administration also released its proposed HHS Budget in Brief.

The Administration seeks to slash the HHS discretionary budget by 25%, from $127 billion in FY 2025 to $95 billion in FY 2026. NIH would be cut by nearly 40% (over $18 billion), funding for the National Institute on Aging (NIA) would plummet from $4.512 billion to $2.687 billion. Simultaneously, the National Institute of Neurological Disorders and Stroke (NINDS) and two largely unrelated institutes would be merged into a single institute with their combined funding dropping from $4.114 billion to $2.445 billion. Taken together, the ability of NIA and NINDS to lead Alzheimer’s disease and related disorders research likely would be crippled. The Administration budget also seeks to codify a 15% cap on facilities and administrative (F&A) costs — an essential component of scientific research grants, critical to research infrastructure. On June 10 at 10:00 a.m. ET,  the Senate Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee, which has jurisdiction over NIH funding, will hold a hearing titled “A Review of the President’s Fiscal Year 2026 Budget Request for the National Institutes of Health” (view webcast). NIH Director Jay Bhattacharya, M.D., Ph.D, will be the sole witness and the hearing will be held in Dirksen Senate Office Building, room 124.

As a direct result of powerful advocacy led by USAging and its allies, the Administration has retreated from its previously announced plan to impose deep funding cuts on Older Americans Act (OAA) programs and services, the State Health Insurance Assistance Programs (SHIPs), Aging and Disability Resource Centers, and Adult Protective Services. The Administration also now proposes that all OAA programs and many other aging and disability programs previously administered by the Administration for Community Living (ACL) be moved to a newly renamed Administration for Children, Families and Communities. None of these programs will move to the Centers for Medicare and Medicaid Services (CMS), and the programs that made up ACL will continue to be housed in one HHS agency, which will allow for continued collaboration between the aging and disability networks to maintain coordination in the delivery of critical services to millions of older adults and caregivers. 

The following Congressional Justifications have been published:

• Administration for a Healthy America (AHA)
• CDC
• CMS
• FDA
• NIA
• NINBR (which would include NINDS)

This entry will be updated periodically as additional details and analysis become available.

House Appropriations Committee releases mark-up schedule

House Appropriations Committee Chair Tom Cole (R-OK) has issued the fiscal year (FY) 2026 markup schedule. The Labor, Health and Human Services, and Related Agencies (Labor-HHS) Appropriations Subcommittee is scheduled to mark up its FY 2026 spending bill on July 21, and the full House Appropriations Committee would mark up the bill on Thursday, July 24.

Improving Seniors’ Timely Access to Care Act reintroduced

The Improving Seniors’ Timely Access to Care Act – bipartisan, zero-cost legislation to improve access to care for seniors enrolled in Medicare Advantage (MA) plans – has been reintroduced by Senators Mark Warner (D-VA) and Roger Marshall (R-KS), along with Representative Ami Bera (D-CA), Mike Kelly (R-PA), Suzan DelBene (D-WA), and John Joyce (R-PA). Last Congress, the bill was supported by a super majority of members in the Senate (60) and a majority in the House (232), and was unanimously passed by the House in 2022. The bill focuses on streamlining the often cumbersome and time-consuming prior authorization process, ultimately allowing healthcare providers to spend more time on patient care rather than administrative burdens. This legislation aims to help clinicians better serve and improve care for the 32.8 million Americans enrolled in MA plans. Audits by the Department of Health and Human Services Inspector General have found that MA plans subjected enrollees to unnecessary delays, incorrectly denied medically necessary care, and ultimately approved 75% of requests that were initially denied.

The legislation would:

• Establish an electronic prior authorization process for Medicare Advantage plans, including a standardization for transactions and clinical attachments.
• Increase transparency around Medicare Advantage prior authorization requirements and their use.
• Clarify HHS’ authority to establish timeframes for e-prior authorization requests, including expedited determinations, real-time decisions for routinely approved items and services, and other prior authorization requests.
• Expand beneficiary protections to improve enrollee experiences and outcomes.
• Require HHS and other agencies to report to Congress on program integrity efforts and other ways to further improve the e-prior authorization process.
• Result in a zero cost to American taxpayers.

NIH issues update on categorical information and FY 2024 spending data 

The National Institutes of Health (NIH) has updated its annual categorical information with actual spending data for fiscal year (FY) 2024. The annual support level for various research, condition, and disease categories are available on the Research, Condition, and Disease Categorization (RCDC) page, The data are based on grants, contracts, intramural projects, and other funding mechanisms used across NIH. There were 215 public categories when RCDC information began being reported for FY 2008. In FY 2024, there are a total of 327 categories. 

The Alzheimer’s Disease including Alzheimer’s Disease Related Dementias (AD/ADRD) category combines and removes duplicate projects found in the Alzheimer’s Disease and the Alzheimer’s Disease Related Dementias (ADRD) categories. Projects reported in this category are from the Alzheimer’s Disease category and/or the Alzheimer’s Disease Related Dementias (ADRD) category. It was established pursuant to Section 230, Division G of the Consolidated and Further Continuing Appropriations Act of 2015 as related to reporting of NIH initiatives supporting the National Alzheimer’s Project Act (NAPA). In FY 2015, NIH invested $631 million in AD/ADRD projects. In FY 2024, NIH invested $3.859 billion in AD/ADRD projects.

Updated resource on impact of NIH grant terminations 

The Association of American Medical Colleges (AAMC) has issued an updated analysis on the impact of NIH grant terminations on U.S. institutions. A previous AAMC analysis detailed the termination of more than 770 NIH grants, after which there was a lengthy pause in updates to publicly reported data from HHS. The agency released updated information on May 19, revealing nearly double the number of grant terminations since its last report. The new analysis shows that 1,424 NIH grants now have been terminated (39% were NIH R01 grants), accounting for $2.4 billion in lost funding across U.S. institutions. 160 active clinical trials have been affected by the cuts.

Alzheimer’s Association launches free mobile app to support newly diagnosed individuals and care partners

The Alzheimer’s Association announced has launched a new mobile app to support newly diagnosed, early-stage individuals and their care partners navigate their journey with Alzheimer’s and other dementias. The free My ALZ Journey app provides personalized guidance, education, planning tools, interactive activities and local community resources. People living with dementia, including current and former members of the Alzheimer’s Association National Early Stage Advisory Group (ESAG), were instrumental in the app’s development — identifying the need for it, helping shape and test its content, and eventually naming it. My ALZ Journey features a simple, intuitive design that guides users through a personalized experience. The Home screen offers a curated path with step-by-step guidance and resources that evolve over time to reflect the user’s journey. The app’s Library provides easy access to topic-based educational content from alz.org, answering common questions about Alzheimer’s, caregiving and planning for the future. Users can connect directly to their local Alzheimer’s Association chapter through the Community section, which highlights nearby support groups, events and programs. The Activity Center offers interactive tools, planning resources and activities to help users stay engaged and supported. The My ALZ Journey app is available now for free in the Apple App Store and Google Play Store. 

FDA approves post-market surveillance study of Alzheimer’s disease prognostic tool

The U.S. Food and Drug Administration (FDA) has approved Darmiyan, Inc.’s post-market surveillance study for BrainSee, its clinical prognostic tool for Alzheimer’s disease. This 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States. The insights gained will support pharmaceutical companies and contract research organizations (CROs) in identifying optimal candidates for next-generation Alzheimer’s clinical trials—advancing both precision and equity in patient selection. BrainSee is an AI-powered technology that combines standard brain MRI, basic cognitive assessments, age, and biological sex to generate a prognostic score. It is the first and only FDA-approved, non-invasive technology that offers clinicians actionable insight into whether patients over the age of 55 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer’s disease within five years. The FDA granted BrainSee marketing authorization in January 2024 via the De Novo pathway. The post-market study will collect, curate, and analyze large-scale data from patients of diverse ethnic and socioeconomic backgrounds via community clinics and hospitals. It will also highlight BrainSee’s clinical utility in underrepresented populations. Darmiyan is collaborating with leading Alzheimer’s Disease Research Centers and nationally recognized datasets, including the National Alzheimer’s Coordinating Center (NACC), the Health & Aging Brain Study – Health Disparities (HABS-HD), the Alzheimer’s Disease Neuroimaging Initiative (ADNI), the University of Alabama at Birmingham (UAB) ADRC, UC Davis ADRC, and the Open Access Series of Imaging Studies (OASIS) of Washington University.

KKF issue brief examines Older Americans Act and proposed changes by Trump Administration

The Kaiser Family Foundation (KFF) has released an issue brief reviewing key aspects of the Older Americans Act (OAA). The brief explains the types of services and programs made available by the OAA, how these programs are administered through federal, state, and local agencies, recent funding levels, and data about the older adults receiving services provided under Title III programs. The number of older adults served and services provided in 2023 include:

• 181 million home-delivered meals and 57 million congregate meals provided
• 1.2 million one-way assisted transportation trips provided
• Nearly 2 million individuals received some type of nutrition counseling and education
• 216,000 individuals received legal assistance

The issue brief also examines the proposed reorganization of the U.S. Department of Health and Human Services (HHS) that would close the Administration for Community Living (ACL) and shift its responsibilities to the Administration for Children, Families, and Communities (ACFC), while reducing staffing for OAA programs and services.

Additional Reads

• Your neighborhood may be tied to risk of inflammation, dementia biomarkers (read here)
• Mayo Clinic’s AI tool identifies 9 dementia types, including Alzheimer’s, with one scan (read here)
• Retinal asymmetry between eyes may serve as early indicator of cognitive frailty (read here)
• 8 recent breakthroughs in the fight against Alzheimer’s disease (read here)
• Blood Tests Forecast Dementia in Down’s Syndrome (read here)
• Improving Alzheimer’s prevention and care (read here)
• USC researchers define brain scan marker to better classify Alzheimer’s disease-related changes (read here)
• Researchers hope to harness the cognitive benefits of a workout for Alzheimer’s patients with mobility issues (read here)
• Semaglutide linked to reduced dementia risk in 1.7 million patients (read here)
• Blood test shows promise for early dementia with Lewy Bodies diagnosis (read here)
• Breast Cancer Survivors may have Lower Alzheimer’s Risk, Linked to Radiation Therapy (read here)
• Critical brain link could explain how Alzheimer’s takes hold (read here)
• Chinese Study Explores the Psychological Well-being and Health of Dementia Caregivers (read here)
• A Loved One Was Diagnosed With Dementia. Now What? Families and experts share their best advice for navigating and coping. (read here)
• Would You Want to Know if Alzheimer’s Were in Your Future? (read here)
• Space-Based Experiment Opens New Avenues in Alzheimer’s Research (read here)
• Researchers identify lost genetic messages as a target for treating dementia (read here)
• How do vaccines reduce the risk of dementia? (read here)
• Modifiable Risk Factors Linked to Spread of Alzheimer’s Tau Tangles, Suggesting Path to Slower Disease Progression (read here)
• Newborns have elevated levels of a biomarker for Alzheimer’s (read here)
• The brain’s sweet spot: How criticality could unlock learning, memory—and prevent Alzheimer’s (read here)
• Regular Running Wards Off Alzheimer’s Signatures in the Hippocampus (read here)
• Congressional Budget Proposal Includes Adjustments to Dual—Eligible Enrollment Pathways and Medicare Savings Program Rules (read here)
• Could a Busier Social Life Be a Very Early Sign of Alzheimer’s? (read here)
• Mechanisms of interventions targeting modifiable factors for dementia risk reduction (read here)
• Alzheimer’s Protective Mutation Works by Taming Inflammation in the Brain (read here)
• Blood Test for Insulin Resistance Predicts Cognitive Decline in Alzheimer’s (read here)
• Dementia: Tactile decline may signal early cognitive impairment (read here) 
• Study: Iron Plays a Major Role in Down Syndrome-Associated Alzheimer’s Disease (read here)
• The simple life changes that can prevent your cognitive decline (read here)
• Former NIH chief calls research cuts “careless” and “heartless” (read here)
• Global study uncovers genetic risk factors for Alzheimer’s Disease across populations (read here)
• How an Alzheimer’s peptide and a blood protein may combine to drive early disease pathology (read here)
• Do Strong Immune Responses Protect People from Dementia? (read here)
• Family and friends shoulder the real cost of dementia − $224B in unpaid care (read here)
• How creative activities can help people with dementia (read here)
• A new bedtime recall exercise may enhance memory in older adults with and without Alzheimer’s Disease (read here)
• The journey to Alzheimer’s diagnosis matters, here’s why (read here)
• NHS patients denied new Alzheimer’s drugs (read here)
• AI Is Detecting Unlikely but Potential Drug Candidates for Neurological Diseases (read here)
• Texas A&M Research Offers Hope For Patients Facing Alzheimer’s (read here)
• Valley of Forgetting: A Journalist’s Journey Into a Land of Inherited Early-Onset Alzheimer’s (read here)
• Transferability of European-derived Alzheimer’s disease polygenic risk scores across multiancestry populations (read here)
• PhD student explores spirituality’s role in dementia care (read here)
• Alzheimer’s Risk Linked to Increased Social Activity, Not Isolation (read here)
• The Cold Shoulder: Grant Freezes, Indefinite Delays Take Their Toll (read here)
• Projected Effects of Proposed Cuts in Federal Medicaid Expenditures on Medicaid Enrollment, Uninsurance, Health Care, and Health (read here)
• Good cognitive health lowers risk of Alzheimer’s disease later in life – but genetics can weaken that protection (read here)
• Bill Gates: I lost my father to Alzheimer’s. But I’m more optimistic than ever about fighting the disease (read here)
• Brain imaging improves Alzheimer’s diagnosis in healthcare (read here)
• Alzheimer’s: bacteria that cause stomach ulcers may protect the brain, our new research indicates (read here)
• Alzheimer’s risk gene may disrupt brain health (read here)
• Brain white matter abnormalities affect cognition and impact Alzheimer’s disease development: study  (read here)
• Cannabis-Related ED Visits, Hospitalizations Tied to Higher Dementia Risk (read here)
• Judge rules some NIH grant cuts illegal, saying he’s never seen such discrimination in 40 years (read here)
• Alzheimer’s disease digital biomarkers multidimensional landscape and AI model scoping review (read here)
• NUS Medicine study finds key blood proteins which predict future cognitive decline (read here)
• Texas A&M Launches Statewide Dementia Research Initiative To Tackle Alzheimer’s Crisis (read here)
• Unlocking Secrets of the Brain to Prevent Alzheimer’s (read here)
• New study shines a light on nieces and nephews caring for relatives with dementia (read here)
• Lance has Alzheimer’s. Here’s what he wants you to know (read here)
• The Silent Symptom Most People Don’t Realize Could Be a Dementia Sign, According to Neurologists (read here)
• The Trump administration’s NIH and FDA cuts will negatively impact patients (read here)
• Nurse practitioners step in as geriatrician ranks shrink (read here)
• Moving from dementia risk disclosure to return of individual research results: a bioethics perspective (read here)
• We May Soon Be Telling a Very Different Kind of Story About Dementia (read here)
• 6 Steps To Preserve Brain Health Now To Prevent Dementia As You Age (read here)
• ‘Transformative’: the UK lab working on a way to halt genetic type of dementia (read here)
• To Understand Alzheimer’s Disease, Researchers Turn to Myelin Sheath (read here)
• Early Behavioral Markers of Loss of Financial Capacity (read here)
• Brain cell discovery may explain excessive hunger (read here)
• Trump’s cuts to more than 1700 NIH grants get court hearing (read here)
• An analysis found that dementia caregivers are more likely to report factors that increase their own dementia risk, including smoking, hypertension (read here)
• Researchers Identify How Physical Activity Protects the Brain—Cell by Cell—in Alzheimer’s Disease (read here)
• Study finds seniors are money savvy – until dementia sets in (read here)
• Chaperone-mediated autophagy directs a dual mechanism to balance premature senescence and senolysis to prevent intervertebral disc degeneration  (read here)
• KU researchers publish specialized clinic model to fast-track access to new Alzheimer’s drugs (read here)
• Neural maps used to locate rewards may be disrupted in dementia and heightened in addiction (read here)
• Scientists map the first step in Alzheimer’s protein aggregation and discover clues for future therapies (read here)
• The same technology that enables targeted immunotherapy for cancer could be used to tackle Alzheimer’s (read here)
• Virtual reality adds empathy to dementia care (read here)
• Circulating Monocytes Replace Microglia, Border-Associated Macrophages (read here)
• ‘Low Quality’: Experts Question Usefulness of Quest’s AD-Detect Blood Test (read here)
• Cycling in Midlife Tied to Lower Risk of Dementia (read here)
• How High Is Your Dementia Risk? It Might Depend on Where You Live (read here)
• Compound Produced by Gut Bacteria May Slow Alzheimer’s Progression (read here)
• Diverse tau pathologies in late‐life mood disorders revealed by PET and autopsy assays (read here)
• Regional Differences in Dementia Incidence Among US Veterans (read here)
• Timing and intraindividual variability of daytime napping and Alzheimer’s disease in older adults (read here)
• Can Sealing Burst Membranes Slow Alzheimer’s Disease Pathology? (read here)
• Mayo Clinic researchers validate blood test to diagnose Alzheimer’s disease in outpatient memory clinics (read here)
• Calls for RFK Jr. to Resign Grow Louder (read here)
• Economic Burden of Alzheimer Disease and Related Dementias by Race and Ethnicity (read here)
• The history of Down syndrome–associated Alzheimer’s disease; past, present, and future (read here)
• Navigating Medicaid for Dementia Care: What Families Need to Know (read here)
• Alzheimer’s Gene Therapy Shows Promise in Preserving Cognitive Function (read here)
• UQ study finds dementia risk drops across generations (read here)
• Rosemary has been linked to better memory, lower anxiety and even protection from Alzheimer’s (read here)
• Creatine shows potential to boost cognition in Alzheimer’s patients (read here)
• Novel truncated RNAs from jumping DNA encode reverse transcriptases in aging human brain (read here)
• Do PERK’d Up Astrocytes Slow Amyloid Clearance? (read here)
• Upgrading Brain’s “Dishwasher” May Help Clear Alzheimer’s Toxins (read here)
• Digital screening during primary care visits may lead to earlier dementia detection, care (read here) 
• Alzheimer’s Disease Research Centers Struggle As 1/3 Lose Their Federal Funding (read here)
• Non-coding variation in dementias: mechanisms, insights, and challenges (read here)
• Epilepsy is more common in patients with frontotemporal dementia than expected (read here)
• Forever Chemicals: The Link Between PFAS and Dementia (read here)
• Immune Discovery Reveals Potential Alzheimer’s Solution (read here)
• Molecular Stress in Old Neurons Increases Susceptibility to Neurodegenerative Diseases, Study Finds (read here)
• Detection of emergency department patients at risk of dementia through artificial intelligence (read here)

May, 2025 News

FDA clears first blood test used in diagnosing Alzheimer’s disease

The U.S. Food and Drug Administration (FDA) has cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease. The test measures two proteins, pTau217 and β-amyloid 1-42, and calculates the numerical ratio; this ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan. Similar FDA-authorized/cleared tests, one from the same company as this new test, are used with cerebrospinal fluid (CSF) samples, which are collected through an invasive lumbar puncture. This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access. 

FDA evaluated data from a multi-center clinical study of 499 individual plasma samples from adults who were cognitively impaired. The samples were tested by the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio and compared with amyloid PET scan or CSF test results. In this clinical study, 91.7% of individuals with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of individuals with negative results had a negative amyloid PET scan or CSF test result. Less than 20% of the 499 patients tested received an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result. These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information.

The risks associated with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio are mainly the possibility of false positive and false negative test results. The study found that 91.7 percent of patients who tested positive for the presence of amyloid were confirmed to have the plaques by brain scans or spinal tap procedures, and 97.3 percent of patients with negative results were similarly confirmed not to have the plaques. For more information, see the Fujirebio statement.

Administration releases radical FY 26 budget proposal

The Trump Administration has released its Fiscal Year 2026 (FY 26) Discretionary Budget Request (see pages 9-14 for an overview of proposed changes at the U.S. Department of Health and Human Services). The Administration seeks to cut the Agency for Healthcare Research and Quality by 35%, the Centers for Disease Control and Prevention (CDC) by 39%, National Institutes of Health (NIH) by 40%, the National Science Foundation by 57%. The Administration’s budget proposal perpetuates its previously initiated plans to eliminate vital agencies including the Administration for Community Living and programs to address many of the most consequential health disparities facing people every community nationwide. At the CDC, the Administration budget plans to eliminate entirely the National Center for Chronic Diseases Prevention and Health Promotion, National Center for Environmental Health, National Center for Injury Prevention and Control, Global Health Center, Public Health Preparedness and Response, and the Preventive Health and Human Services Block Grant. The Administration budget also appears to propose a radical reorganization of NIH’s 27 institutes and centers into five new institutes: the National Institute on Body Systems Research; National Institute on Neuroscience and Brain Research (presumably incorporating whatever would remain of the current National Institute on Aging and National Institute of Neurological Disorders and Stroke); National Institute of General Medical Sciences; National Institute of Disability Related Research; and National Institute on Behavioral Health.

For insight regarding the Administration’s proposed cuts, see statements from the Alzheimer’s Association, the Ad Hoc Group for Medical Research, USAging, and the American Brain Coalition. 

Senate Appropriations hearings on biomedical innovation

Senators Susan Collins (R-ME) and Patty Murray (D-WA), Chair and Vice Chair of the Senate Appropriations Committee, have scheduled a two-part full committee hearing series, “Biomedical Research: Keeping America’s Edge in Innovation.”  On April 30, the Senate Appropriations Committee held the first hearing, which featured researchers and stakeholder groups to discuss the importance of U.S. biomedical research for the nation’s health and economy.  A second hearing, which will occur on a later date, will include Administration witnesses testifying on the federal government’s role in investing in and fostering biomedical innovation.

Alzheimer’s Association publishes annual Facts and Figures report and special report on early detection and treatment 

The Alzheimer’s Association has released its 2025 Alzheimer’s Disease Facts and Figures report and executive summary, providing an in-depth look at the latest national statistics on Alzheimer’s incidence, prevalence, mortality, costs of care, and impact on caregivers. Among the findings:

• 7.2 million people aged 65 and older are living with Alzheimer’s disease.
• Total annual costs of caring for people living with Alzheimer’s and other dementias (excluding unpaid care) is projected to be $384 billion in 2025.
• Additionally, nearly 12 million family members and friends provide 19.2 billion hours of unpaid care, valued at an additional $413 billion.
• Deaths due to Alzheimer’s disease more than doubled between 2000 and 2022.

The accompanying special report, American Perspectives on Early Detection of Alzheimer’s Disease in the Era of Treatment, examines awareness and attitudes about Alzheimer’s disease, early detection and diagnosis, tests used to help diagnose Alzheimer’s, and treatments that can slow progression of the disease. The report highlights several key efforts needed to improve early detection, diagnosis and treatment in the current environment, including:

• Supporting research to validate and advance biomarker testing so it can be used widely in clinical settings to detect and diagnose Alzheimer’s disease at the earliest stages.
• Creating clinical practice guidelines to keep pace with rapidly evolving science. The Alzheimer’s Association is preparing guidelines on blood-based biomarker tests (anticipated in 2025), cognitive assessment tools (anticipated in 2025), and clinical implementation of staging criteria and treatment (anticipated in 2026).
• Improving physician-patient conversations about testing, diagnosis and treatment so patients and their caregivers better understand the meaning of test results and the risks and benefits of new treatments. Physicians should have access to training to deliver information in a way that is easy for patients to understand.
• Addressing ethical concerns of early detection by making sure patients understand that tests only measure potential risk and that a formal diagnosis involves cognitive testing and other assessments, including the health professional’s clinical judgment. Counseling patients in advance and making sure that test results are shared by a physician who provides context can help avoid misinterpretation or undue emotional distress.
• Advocating for laws and policies that require insurance coverage of tests, which will speed up diagnosis and provide faster access to treatments that slow disease progression and support better care planning.
• Fostering public health efforts to educate health care providers and the public about the latest research and best practices for risk reduction, diagnosis, treatment and safe, high-quality care.

EBRI releases issue brief on worker attitudes about long term care 

The Employee Benefit Research Institute has released an issue brief, “Employee Perspectives on Long-Term Care,” which examines employees’ awareness of, access to, and perspectives on LTC financing. The issue brief is based on a survey of 2,445 workers, ages 20 through 74, and uncovered emerging insights while reaffirming well-established LTC awareness and preparedness trends. A significant share of employees either said they expect to need long-term care or had caregiving experience, yet awareness, planning, and benefit take-up remained low. Many workers underestimated costs, were unsure how to access services, and mistakenly expected Medicare or Medicaid to cover future care. Employees’ perceptions of their LTC needs were influenced by personal experience and socioeconomic status, highlighting an opportunity for employer-informed, public-private solutions paired with targeted education efforts.

Justice in Aging publishes D-SNP contract toolkit

Justice in Aging (JiA) has published its Dual Eligible Special Needs Plan (D-SNP) State Medicaid Agency Contract Toolkit. The toolkit includes a document addressing eligibility, enrollment and supplemental benefits, and a separate document addressing marketing and communications. Cumulatively, the toolkit provides advocates and State Medicaid Agency policymakers with principles and corresponding template language to develop State Medicaid Agency Contracts (SMACs)  responsive to the needs of the dually eligible populations that they serve. Stakeholders are encouraged to use this tool to advance their priorities, utilizing and tailoring the most appropriate components for their state’s integrated environments. D-SNPs are a type of Medicare Advantage plan designed to serve individuals dually enrolled in Medicare and Medicaid. As enrollment in D-SNPs increases significantly nationwide, these health plans must meet the unique health and social needs of the dually eligible population. JiA plans to add additional documents to the toolkit at a later time.

AAMC releases analysis on impact of NIH grant terminations 

The Association of American Medical Colleges released a new analysis on the impact of National Institutes of Health (NIH) grant terminations on U.S. institutions. To date, U.S. institutions have lost $1.9 billion in funding across 777 terminated NIH grants, including 245 R01 grants and over 100 active clinical trials spanning a broad range of diseases. This data brief provides insight into the nature of terminated grants as institutions grapple with loses in funding and impacts to the pace of scientific progress.

Additional Reads

• Memory cafes offer camaraderie and fun for people with dementia — and their caregivers (read here)
• Alzheimer’s Association launches free app for newly diagnosed dementia patients (read here)
• Can this nasal spray slow down Alzheimer’s? One couple is helping scientists find out (read here)
• Common gene variant doubles dementia risk for men (read here)
• Predicting and preventing Alzheimer’s disease (read here)
• Depression is linked to an increased risk of dementia in both mid and later life, finds a new study (read here)
• Accelerated brain ageing and dementia (read here)
• Astrocytes, the Gatekeepers of Norepinephrine Signaling in the Brain (read here)
• Chronic stress contributes to cognitive decline and dementia risk – 2 healthy-aging experts explain what you can do about it (read here)
• Research untangles role of stress granules in neurodegenerative disease (read here)
• Yale Scientists Uncover Sex Differences in Recalling and Reporting of Family History of Alzheimer’s Disease (read here)
• Sleep aid blocks neurodegeneration in mice (read here)
• Investing in Relationships Builds Resilience for Dementia Caregivers, Study Finds (read here)
• Different versions of APOE protein have varying effect on microglia in Alzheimer’s disease (read here)
• No Mere Microglial Marker, TMEM119 Supports Aβ Phagocytosis (read here)
• Scientists test real-time view of brain’s waste removal (read here)
• New State Laws Require Insurance to Cover Alzheimer’s Biomarker Tests (read here)
• Rural Georgians lack access to Alzheimer’s disease treatment (read here)
• Racial ethnic variations in the cardiometabolic determinants and blood pressure of white matter hyperintensities among females—The HABS‐HD Study (read here)
• Treatment of agitation in dementia – a systematic review (read here)
• New discovery on factors related to Alzheimer’s disease progression (read here)
• How to spot dementia early and reduce your risk by half (read here)
• Sex differences in amyloid PET in a large, real‐world sample from the Imaging Dementia–Evidence for Amyloid Scanning (IDEAS) Study (read here)
• How the GOP’s proposed Medicaid cuts could affect millions of family caregivers (read here)
• The Meaning of Goodbye (read here)
• Breakthroughs in Alzheimer’s prevention (read here)
• The 78th World Health Assembly agrees to extend the Global Action Plan on the Public Health Response to Dementia (read here)
• Mindfulness may be a window into brain health in early Alzheimer’s risk (read here)
• STING deletion protects against amyloid β–induced Alzheimer’s disease pathogenesis (read here)
• The Effect of Influenza Vaccination on Hospitalization and Mortality Among People With Dementia (read here)
• An Expensive Alzheimer’s Lifestyle Plan Offers False Hope, Experts Say (read here)
• Are Artery Exosomes to Blame for Vascular Cognitive Impairment? (read here)
• Potential new treatment for Alzheimer’s disease, other neurodegenerative conditions (read here)
• Trump and GOP’s tax bill would force cuts to Medicare, CBO says (read here)
• Psychological impact of biomarker-assisted diagnosis of Alzheimer’s disease (read here)
• Flipping the script on dementia language (read here)
• Cold sore viral infection implicated in development of Alzheimer’s disease (read here)
• Insulin resistance in the brain may be one of the factors linking Alzheimer’s disease and epilepsy (read here)
• NeuroVoices: Brad Kamitaki, MD, on Aiming to Improve Dementia Care in Asian and Pacific American Communities (read here)
• Candidate drug that boosts protective brain protein in mice has potential to treat Alzheimer’s Disease (read here)
• Incidence and prevalence of dementia among US Medicare beneficiaries, 2015-21: population based study (read here)
• Scientists discover potential new targets for Alzheimer’s drugs (read here)
• Novel algorithms & blood‐based biomarkers: Dementia detection and care transitions for persons living with dementia in the emergency department (read here)
• Brains Run on Good Sleep. Researchers Are Closer to Understanding Why (read here)
• How AI can improve dementia detection (read here)
• Sex differences in prodromal dementia with Lewy bodies using the National Alzheimer’s Coordinating Center data (read here)
• An integrated deep learning model for early and multi-class diagnosis of Alzheimer’s disease from MRI scans (read here)
• How do patients, medical assistants and physicians accept and experience tablet-based cognitive testing by medical assistants in general practice? – A qualitative study (read here)
• In Clinical Use, Most ARIA Occurs in People With Dementia, Not MCI (read here)
• Stress can lead to Alzheimer’s disease in women who are post-menopausal, UT Health San Antonio study finds (read here)
• Study reveals impacts of Alzheimer’s disease on the whole body (read here)
• Trends in Home Health Care Among Traditional Medicare Beneficiaries With or Without Dementia (read here)
• USC researchers develop low-cost blood test for early Alzheimer’s detection (read here)
• Contrary to Clear, Verifiable Facts, Secretary Kennedy Continues to Repeat Harmful Myths About Alzheimer’s and Dementia Research (read here)
• Heavyweight Tau Snuffs Out Hippocampal Bursts (read here)
• The roots of dementia can start in childhood – prevention should be a lifelong goal (read here)
• USC study reveals link between type 2 diabetes and brain health in older adults from various populations (read here)
• Referral Criteria for Specialist Palliative Care for Patients With Dementia (read here)
• Sugar-coated nanotherapy dramatically improves neuron survival in Alzheimer’s model (read here)
• Too much sleep can hurt cognitive performance, especially for those with depression, UT Health San Antonio study finds (read here)
• Loss of smell linked to higher risk of death and dementia (read here)
• Researchers develop a potential new drug for Alzheimer’s and pain treatment (read here)
• Gene variant protects against inherited form of dementia: Researchers (read here)
• Study reveals sedentary behavior is an independent risk factor for Alzheimer’s disease (read here)
• Dementia risk depends on more than lifestyle factors. Overstating this can cause stigma and blame (read here)
• Drug to slow Alzheimer’s well tolerated outside of clinical trial setting (read here)
• Poor heart health increases risk of dementia for Black Americans (read here)
• Is a Cellular ‘Stalled Engine’ Causing Alzheimer’s? (read here)
• Addressing Hearing Loss May Reduce Isolation Among the Elderly (read here)
• Cell death discovery could lead to next-gen drugs for neurodegenerative conditions (read here)
• A scoping review of remote and unsupervised digital cognitive assessments in preclinical Alzheimer’s disease (read here)
• Realizing The Promise Of The GUIDE Model For Dementia Caregivers (read here)
• Wearable sleep recording augmented by artificial intelligence for Alzheimer’s disease screening (read here)
• An Enzyme as Key to Protein Quality (read here)
• Characterization of Research Grant Terminations at the National Institutes of Health (read here)
• Using Negative Emotions for Positive Outcomes in the Dementia Journey (read here)
• Confirmed: Lowering Blood Pressure Cuts Risk of Dementia (read here)
• Researchers Identify Measure of Pulse Rate That Can Predict Faster Cognitive Decline in Older Adults (read here)
• A digital intelligence visualization health monitoring device for Alzheimer’s disease patients based on WBAN technology (read here)
• What a New MRI Meta-Analysis Reveals About AI-Powered Hippocampal Segmentation and Alzheimer’s Disease (read here)
• HIV Drugs Offer ‘Substantial’ Alzheimer’s Protection (read here)
• Hearing loss in middle age may accelerate cognitive decline (read here)
• A systematic analysis for disease burden, risk factors, and trend projection of Alzheimer’s disease and other dementias in China and globally (read here)
• Are you curious? It might help you stay sharp as you age (read here)
• Knowing Your Alzheimer’s Risk May Ease Anxiety but Reduce Motivation for Healthy Habits (read here)
• Emotional response to amyloid beta status disclosure among research participants at high dementia risk (read here)
• EEG-based neurodegenerative disease diagnosis: comparative analysis of conventional methods and deep learning models (read here)
• Alzheimer’s Studies Are Diversifying. Will Scientists Be Able to Finish the Job? (read here)
• Next Act for Amyloid Immunotherapy: Be Safer, Target Tau, Too (read here)
• Most people say they want to know their risk for Alzheimer’s dementia, fewer follow through (read here)
• Alzheimer’s: certain combinations of prescription drugs may slow progression of the disease, says mice study (read here)
• Cutting greenhouse gases will reduce number of deaths from poor air quality (read here)
• Brain networks rewire to compensate for difficulty hearing speech in noisy environments (read here)
• My Care Recipient’s Doctors Don’t Respect My Boundaries (read here)
• Sleep disturbances and disorders in the memory clinic: Self-report, actigraphy, and polysomnography (read here)
• Sex differences in sleep apnea and Alzheimer’s Disease: role of cerebrovascular dysfunction (read here)
• Menopause symptoms may be critical to understanding Alzheimer’s disease risk in women (read here)
• Correlations between agitation and other neuropsychiatric symptoms in each stage of Alzheimer’s disease: A re-analysis of CATIE-AD (read here)
• Researchers develop model that predicts onset of Alzheimer’s disease (read here)
• Black tea and berries could contribute to healthier ageing (read here)
• The Dementia Diagnosis Gap Is Wider Than We Think (read here)
• Loss of WDR23 slows the rate of age-related cognitive decline with elevated amyloid burden (read here)
• Her partner of 45 years developed Alzheimer’s. She’s sharing their story to ‘take away fear’ (read here)
• Down Syndrome and Alzheimer’s: Clinical Trials, Equity, and Patient-Centered Progress (read here)
• Intimate partner violence and cognitive functioning – toward quantifying dementia risk (read here)
• Inflammasome signaling in astrocytes modulates hippocampal plasticity (read here)
• Scientists reel as turmoil roils National Science Foundation (read here)
• Molecular double agent: Protein “Eato” plays surprising role in protecting the brain (read here)
• Thirty years on, our research linking viral infections with Alzheimer’s is finally getting the attention it deserves (read here)
• Triple Trouble: New Knock-in Turbocharges Tauopathy (read here)

April, 2025 News

LEAD Coalition and SWHR submit public comment letter to FDA on study of sex differences

On April 7, 304 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Food and Drug Administration (FDA) regarding its draft guidance for the study of sex differences in the clinical evaluation of medical products (Docket No. FDA-2024-D-4245). The letter, co-led by the Society for Women’s Health Research, supports the draft guidance, urges the FDA to implement a comprehensive framework that considers sex as a fundamental variable throughout drug and device development, approval, and post-market processes across disease. The letter also makes three sets of recommendations. Read the letter here.

LEAD Coalition and allies press for immediate halt to HHS staff and funding cuts

The day after the U.S. Department of Health and Human Services (HHS) initiated deep staff and funding cuts along with agency closures, a diverse group of organizations called for the Administration to halt immediately any further steps that will reverse progress toward effective prevention, treatment, and care for people facing Alzheimer’s disease and related disorders. Organizations that would like to join the updated list of signatories are encouraged to contact LEAD Coalition executive director Ian Kremer as soon as possible.

The full statement and list of signatories follows:

We, the undersigned organizations, are deeply concerned that additional reductions in staff and funding for dementia programs across the Department of Health and Human Services (HHS) will reverse progress toward effective prevention, treatment, and care. Half of all American families have been touched by Alzheimer’s or other forms of dementia, and we have all benefited from the bipartisan commitment to ending this disease.

We count on a strong disease prevention program at the CDC, on research toward cures and care at the NIH, on world-class scientific experts at FDA, on Meals on Wheels and other programs from the Administration for Community Living, and on coordination of all of these efforts through staff at the HHS headquarters. The agencies affected by these cuts are at the heart of the progress America has made toward better understanding how to prevent and treat these devastating diseases. Cuts made without a clear, public plan to continue these efforts will have enduring and tragic consequences for millions of families, increase the economic burden on our nation and on families caring for the millions of Americans with these diseases, and could derail progress toward the goals established under the National Alzheimer’s Project Act and its reauthorization (passed unanimously by Congress in 2024).

We commend the bipartisan calls for greater transparency in how these decisions are being made and urge the Administration to immediately halt any further cuts. It is essential to first engage with stakeholders—patients, caregivers, researchers, and organizations like us—to ensure we protect the progress we’ve made and chart a responsible path forward.

Fiscal efficiency must not come at the expense of patients, caregivers, or the research that offers hope for a cure. We stand ready to work in partnership to find solutions that uphold both public health and financial stewardship.

Signed,

Alliance for Aging Research
American Society on Aging
Association of Population Centers
Alzheimer’s Association
Alzheimer’s Impact Movement
Alzheimer’s Los Angeles
Alzheimer’s Orange County
Alzheimer’s San Diego
Association for Frontotemporal Degeneration
Benjamin Rose Institute on Aging
BrightFocus Foundation
Caregiver Action Network
CaringKind
Family Caregiver Alliance
Gerontological Advanced Practice Nurses Association
Gerontological Society of America
Hilarity for Charity
International Association for Indigenous Aging
Justice in Aging
The John A. Hartford Foundation
LEAD Coalition (Leaders Engaged on Alzheimer’s Disease)
LuMind IDSC Foundation
Medicare Rights Center
National Alliance for Caregiving
National Association of Social Workers
National Down Syndrome Society
National Indian Council on Aging
The National Minority Quality Forum
Ohio Council for Cognitive Health
UsAgainstAlzheimer’s

HHS issues information on canceled grants

HHS continues to issue information on terminated awards (see spreadsheet) through the Department’s publicly available Tracking Accountability in Government Grants System (TAGGS) website. According to HHS, the spreadsheet of terminated awards, which includes NIH grants, is aligned with the presidential memo on “Radical Transparency About Wasteful Spending.” The spreadsheet of terminated awards includes information on the awarding office, award number, recipient name, date terminated, total award amount for the budget period, anticipated amount canceled as a result of the termination, and award title.

CMS issues 2026 MA, Part D payment policy and redesign program instructions

The Centers for Medicare & Medicaid Services (CMS) has finalized the 2026 Medicare Advantage (MA) and Part D updates to payment factors. For MA plans, CMS projects an average increase in payment rates of 5.06%, representing a $25 billion increase in payments. CMS attributes the increase to the growth in Medicare Fee-for-Service (FFS) per capita costs. CMS also released the final 2026 Part D Redesign Program Instructions, which provide guidance regarding implementing the Inflation Reduction Act of 2022’s (IRA) changes to the defined standard Part D drug benefit structure. The key changes include the 2026 annual out-of-pocket (OOP) threshold of $2,100, guidance on the successor regulation exception to the IRA’s formulary inclusion requirement for selected drugs, and the revised simplified determination methodology for creditable drug coverage, among other guidance. For additional details, read the CMS fact sheet.

FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs

The U.S. Food and Drug Administration (FDA) has announced plans to replace animal testing in the development of monoclonal antibody therapies and other drugs. The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in the FDA’s new Roadmap to Reducing Animal Testing in Preclinical Safety Studies. To make determinations of efficacy, the agency will begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has been studied in humans. The FDA and federal partners will host a public workshop later this year to discuss the roadmap and gather stakeholder input on its implementation. Over the coming year, the FDA aims to launch a pilot program allowing select monoclonal antibody developers to use a primarily non-animal-based testing strategy, under close FDA consultation. Findings from an accompanying pilot study will inform broader policy changes and guidance updates expected to roll out in phases.

Over 500 organizations recommend $51.3 billion for NIH

The LEAD Coalition has joined more than 500 organizations in supporting the Ad Hoc Group for Medical Research letter urging Congress to provide at least $51.3 billion for the National Institutes of Health (NIH) for fiscal year (FY) 2026, in addition to support for the Advanced Research Projects Agency for Health (ARPA-H). Specifically, the recommendation for NIH would represent a $4.222 billion or 9.0% increase over the final FY 2025 funding level (due to the full-year Continuing Resolution, the FY 2025 level represented no increase for NIH from FY 2024 appropriations). The recommendation notes, “Robust support for medical research makes Americans healthier. Patients across the country — from urban centers to rural communities — benefit from medical research supported by the NIH, which serves as the foundation for nearly every preventive intervention, diagnostic, treatment, and cure in practice today.” In addition, the Ad Hoc Group shared an accompanying question and answer (Q&A) document for the FY 2026 recommendation. The Q&A document provides an overview of the justification for the FY 2026 recommendation and messages on the importance of NIH investment for driving economic growth and securing U.S. global leadership. It also highlights the harmful impacts of funding delays and disruptions, among other issues.

LEAD Coalition welcomes new member organizations

The LEAD Coalition recently welcomed the Advanced Medical Technology Association® (AdvaMed®) and Cognito Therapeutics as its newest member organizations.

AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve healthier lives around the world. AdvaMed®’s more than 500 members range from the largest to the smallest medical technology innovators and companies. The Association acts as the common voice for companies producing medical devices, diagnostic products and digital health technologies. AdvaMed® promotes competitive policies that foster the highest ethical standards, appropriate reimbursement, and access to international markets. 

Cognito Therapeutics is a pioneer in non-invasive neuromodulation to treat neurodegenerative diseases and improve human cognitive performance. Cognito has received FDA Breakthrough Device Designation for the treatment of Alzheimer’s disease. The company has completed multiple clinical studies, including the Phase 2 OVERTURE study, demonstrating its investigational therapeutic has the potential to safely slow or stop cognitive decline and loss of brain volume in Alzheimer’s disease. Cognito currently is recruiting for its pivotal HOPE study. The company’s technology, used in over 40,000 patient sessions, was based on pioneering optogenetics research by scientific co-founders Professors Li-Huei Tsai and Ed Boyden at MIT. 

District court strikes down key components of CMS nursing home staffing rule

The U.S. District Court for the Northern District of Texas has vacated key provisions of the U.S. Centers for Medicare and Medicaid Services (CMS) final rule establishing minimum staffing requirements for long-term care facilities. The rule, scheduled to take effect in 2026, would have required an on-site registered nurse (RN) 24 hours a day, a minimum staffing per resident of 0.55 hours per day for RNs, 2.45 hours per day for nursing assistants, and 3.48 hours per day for total nurse staffing. The court held that when Congress has spoken clearly — such as by requiring only eight hours per day of RN coverage — an agency cannot replace that standard with a broader mandate under general regulatory authority. The court also found that CMS failed to meet statutory requirements to tailor staffing requirements to the needs of each facility’s resident population. The 3.48 hours per resident per day (HPRD) formula, the court held, unlawfully substituted a one-size-fits-all benchmark in place of individualized assessment, contrary to the governing statute. The court left in place some provisions such as Medicaid transparency rules. Read the court’s ruling.

District court vacates FDA final rule on laboratory developed tests

The U.S. District Court for Eastern District of Texas has vacated the U.S. Food and Drug Administration (FDA) final rule regulating laboratory-developed tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA). The court ruled that LDTs are professional services regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA), not tangible products under FDA’s jurisdiction. This decision relies on the precedent set by the Supreme Court in Loper Bright Enterprises v. Raimondo. For now, the ruling has nationwide effect, but future congressional action may affect such decisions. Read the court’s ruling. For additional details and analysis, click here.

Additional Reads

• Scientists Uncover How Tau Protein Weakens the Brain’s Vascular Defenses in Alzheimer’s Disease (read here)
• The Risks and Genetics of Alzheimer’s Disease (read here)
• Alzheimer’s Association calls on doctors to use newer early diagnostic testing due to improvements (read here)
• Signs of dementia or normal forgetfulness? How to tell the difference (read here)
• How Public Supported Studies Bring This Researcher and Patient Closer to a Cure for Alzheimer’s (read here)
• ‘Smart insoles’ could help diagnose dementia, other health problems (read here)
• Association between high plasma p-tau181 level and gait changes in patients with mild cognitive impairment (read here)
• Trontinemab Fuels Hope for Brain Shuttle Lift-Off (read here)
• AI Helps Unravel a Cause of Alzheimer’s Disease and Identify a Therapeutic Candidate (read here)
• Rapidly Progressive Dementia: Key Factors That May Aid Diagnosis (read here)
• An Alzheimer’s study in South America offered tremendous insights. Then it was cut. (read here)
• Brain’s ‘blue spot’ key to healthy aging, early Alzheimer’s detection (read here) 
• Even Light Exercise Could Help Slow Cognitive Decline in People at Risk of Alzheimer’s (read here)
• Dementia care: are terms of endearment like ‘sweetheart’ comforting or condescending? (read here)
• Study Shows Higher Fall Risk for Older Adults with Alzheimer’s Compared to Mild Cognitive Impairment (read here)
• Empathy might be retained in Alzheimer’s disease (read here)
• There Are Ways to Make Life Easier for Patients with Alzheimer’s Disease and Their Caregivers (read here)
• The Cost of Dementia in 2025 (read here)
• New clues as to why drugs are effective for Alzheimer’s disease (read here)
• Isolated older adults find joy and connection through virtual singing. Those with neurocognitive disorders like dementia especially benefit. (read here)
• New Research Lays Groundwork for Early Detection of Alzheimer’s Disease (read here)
• Sex Hormones Are Brain Hormones. What Does This Mean for Treating Brain Diseases? (read here)
• A New Take on How Tau Spreads in the Brain — and Speeds Up Alzheimer’s (read here)
• New NIH grant rules override the Civil Rights Act of 1964, barring recipients from DEI activities (read here)
• Intensive lowering of blood pressure tied to lower dementia risk (read here)
• Engineered microglia show promise for treating Alzheimer’s, other brain diseases (read here)
• UT Health San Antonio-led discovery means IV medication could be taken orally for range of cancer, Alzheimer’s treatments (read here)
• When They Don’t Recognize You Anymore (read here)
• Global trends in prevalence, disability adjusted life years, and risk factors for early onset dementia from 1990 to 2021 (read here)
• Tau PET as Progression Marker: It’s the Spread, Not the Brightness (read here)
• Lifesaving Alzheimer’s Research Delayed by Trump Funding Cuts (read here)
• Drug Development Is Slowing Down After Cuts at the FDA (read here)
• Population Attributable Fraction of Incident Dementia Associated With Hearing Loss (read here)
• Five reasons why young-onset dementia is often missed (read here)
• Reduced Deep and REM Sleep Could be Early Markers of Alzheimer’s (read here)
• Modulating the Brain’s Immune System May Curb Damage in Alzheimer’s (read here)
• Moving Target: New Biology Casts TREM2 as a Shifty Mark (read here)
• Mouse model reveals how a mutation protects against Alzheimer’s disease (read here)
• Integrative approach reveals promising candidates for AD risk factors or targets for treatments (read here)
• Understanding the Emotional Toll of Alzheimer’s Disease (read here)
• Women, minorities fired in purge of NIH science review boards (read here)
• Why women experience Alzheimer’s disease differently from men (read here)
• Menopause at an Early Age Can Exacerbate Cognitive Decline (read here)
• Towards Gene-Targeting Drugs Capable of Targeting Brain Diseases (read here)
• Association of Nonmodifiable Risk Factors With Alzheimer Disease Blood Biomarkers in Community-Dwelling Adults in the ESTHER Study (read here)
• Hereditary Alzheimer’s: Blood Marker for Defective Neuronal Connections Rises Early (read here)
• Popular diabetes medications may protect against Alzheimer’s disease, UF researchers find (read here)
• Leqembi® (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorized in the European Union (read here)
• NIH terminates $13 million grant on dementia risks for sole nationally representative mental health sample of Black Americans (read here)
• Cognitively Impaired Older Drivers Are Less Likely to Cause a Crash When Accompanied by a Passenger (read here)
• Global telemedicine therapy for dementia shows benefit (read here)
• AI tool unlocks long-standing biomedical mystery behind Alzheimer’s, Parkinson’s (read here)
• As dementia rates increase, experts warn hospital emergency rooms are underprepared (read here)
• Benefits and Risks of New Tests for Alzheimer’s Disease (read here)
• It Takes Tau to Tangle: Is Faster Buildup Driving Women’s Alzheimer’s Risk? (read here)
• Scientists Identify Key Enzyme in Alzheimer’s Disease That Links Brain Inflammation to Memory Loss (read here)
• Digital Dementia: Does Technology Use by ‘Digital Pioneers’ Correlate to Cognitive Decline? (read here)
• Risk of dementia in individuals with emergency department visits or hospitalizations due to cannabis (read here)
• One of the country’s leading Alzheimer’s projects is in jeopardy (read here)
• Experiences and perceptions of sexism in dementia research careers: A global cross-sectional survey (read here)
• New Partnership Forms to Harness AI for Alzheimer’s Research (read here)
• Atrophy trajectories in Alzheimer’s disease: how sex matters (read here)
• First Participant With Down syndrome (DS) Dosed in Landmark Phase 1b HERO Study For the Potential treatment of Alzheimer’s disease (AD) (read here)
• More opportunities to test for Alzheimer’s using new analytical method (read here)
• Journey to Diagnosis: Real-Life, Personal Stories of Navigating Cognitive Decline (read here)
• A gene guiding brain cell growth may regulate Alzheimer’s plaque size and toxicity (read here)
• Can Stem Cells Address Behavioral Symptoms in Alzheimer’s Patients? (read here)
• Alzheimer’s Association expands PSA campaign about early dementia signs to focus on Black Americans (read here)
• Association Between Alcohol Consumption, Cognitive Abilities, and Neuropathologic Changes (read here)
• Potential Alzheimer’s Disease Therapeutic Target Identified in Brain Immune Cells (read here)
• Students lead breakthrough study on diabetes drugs and dementia risk (read here)
• Ohio State study reveals new insights into neurodegeneration (read here)
• Scientists complete largest wiring diagram and functional map of the brain to date (read here)
• Plasma phospho-tau217 for Alzheimer’s disease diagnosis in primary and secondary care using a fully automated platform (read here)
• Discovery of Mitochondrial Protein Opens Path to Therapeutic Advances for Heart and Alzheimer’s Disease (read here)
• ALS drug effectively treats Alzheimer’s disease in new animal study (read here)
• Eye health linked to dementia risk (read here)
• Redefining Value in Care for Alzheimer’s Disease and Dementia (read here)
• Personalized Alzheimer’s Risk Reduction Software Improves Calculated Alzheimer’s Risk: A Digital, Decentralized, Randomized Controlled Trial (P1-3.004) (read here)
• PolyU scholar unveils research on long-term effects of obesity on brain and cognitive health (read here)
• States Propose Bills to Make Private Insurers Cover Approved Alzheimer’s Drugs, Diagnostics (read here)
• Exposure to air pollution may harm brain health of older adults (read here)
• Finding a new drug target to treat Frontotemporal Lobar Degeneration (read here)
• Linking blood flow and brain health (read here)
• Confronting Alzheimer’s Disease: The Changing Biomarker and Treatment Landscape (read here)
• Biotech start-ups struggle as Trump throttles NIH funding (read here)
• Gamma Sensory Stimulation Preserves Corpus Callosum, P-Tau 217 and 181 Correlate With Clinical Outcomes, Lecanemab ARIA Risk Highest in Elevated Aß42/Total Tau Ratios (read here)
• FDA will consolidate to five ‘shared services offices,’ according to memo to Hill staffers (read here)
• Alzheimer’s research was never a waste of time. Let’s not lose progress. (read here)
• Do Synaptic Markers Foreshadow Cognitive Decline? (read here)
• What Can We Learn About Dementia from LGBTQ+ Brain Health Research? (read here)
• Following layoffs, the future of FDA’s user fee programs is in extreme jeopardy (read here)
• America’s Brightest Minds Will Walk Away (read here)
• Key differences between visual- and memory-led Alzheimer’s discovered (read here)
• Cognitive decline comes sooner for people with heart failure (read here)
• Mass General Brigham Researchers Reveal 17 Modifiable Risk Factors Shared by Stroke, Dementia, and Late-Life Depression (read here)
• Unlocking memories of the past with the soundtrack of a lifetime (read here)
• Researchers Identify New Targeted Approach to Protect Neurons Against Degeneration (read here)
• Religious stress coping is associated with lower entorhinal tau pathology and better memory performance in autosomal dominant Alzheimer’s disease (read here)
• Blood test may rule out future dementia risk (read here)
• Study strengthens link between shingles vaccine and lower dementia risk (read here)
• People with dementia could stay in the workplace longer – with the right tech (read here)
• AI effectively predicts dementia risk in American Indian/Alaska Native elders (read here)
• Blood test may rule out future dementia risk (read here)
• Study strengthens link between shingles vaccine and lower dementia risk (read here)
• People with dementia could stay in the workplace longer – with the right tech (read here)
• AI effectively predicts dementia risk in American Indian/Alaska Native elders (read here)
• Remote Screening for Early Alzheimer Holds Promise Amid Key Challenges (read here)
• Low LDL cholesterol levels linked to reduced risk of dementia (read here)
• Weight training protects older people’s brains against dementia, study suggests (read here)
• UB researchers develop a new compound with therapeutic potential against Alzheimer’s disease (read here)
• ‘One of the darkest days’: NIH purges agency leadership amid mass layoffs (read here)
• UCalgary researchers find important clues contributing to Alzheimer’s disease (read here)
• University of Minnesota Medical School study identifies key heart marker predicting ischemic stroke and dementia (read here)

March, 2025 News

HHS announces radical reorganization with deep staff cuts and closing of agencies

The U.S. Department of Health and Human Services (HHS) has announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” According to HHS, the decision will include cutting approximately 10,000 full-time employees (when combined with HHS’ other efforts, the restructuring will eliminate roughly 20,000 full-time employees). The U.S. Food and Drug Administration (FDA) is expected to lose 3.500 people, the Centers for Disease Control and Prevention will lose 2,400 people, the National Institutes of Health will lose 1,200 people, and the Centers for Medicare and Medicaid Services (CMS) will lose 300 people.

The plan will collapse 28 HHS divisions into 15 new divisions and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to five. Among the specific contents of the restructuring plan that have been announced so far are as follows:

• Creation of the Administration for a Healthy America (AHA), which will combine multiple agencies — the Office of the Assistant Secretary for Health (OASH), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Toxic Substances and Disease Registry (ATSDR), and National Institute for Occupational Safety and Health (NIOSH) — into a new, unified entity. 
• HHS will create a new Assistant Secretary for Enforcement to oversee the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeals (OMHA), and Office for Civil Rights (OCR).
• HHS will merge the Assistant Secretary for Planning and Evaluation (ASPE) with the Agency for Healthcare Research and Quality (AHRQ) to create the Office of Strategy.
• HHS will close the Administration for Community Living (ACL) and move programs that support older adults and people with disabilities into other HHS agencies, including the Administration for Children and Families (ACF), ASPE, and the Centers for Medicare and Medicaid Services (CMS). 

For analysis, see this FAQ about the staffing cuts at FDA, this Forbes article about the impact on ACL, and statements from the National Alliance for Caregiving, the Medicare Rights Center, and the American Society on Aging.

NIH releases plan to centralize peer review process

The National Institutes of Health (NIH) recently released plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within the agency’s Center for Scientific Review (CSR). The proposed centralization plan would apply to the first stage of the review process and the consolidation would transition study sections that take place across NIH Institutes and Centers (ICs) to CSR for all first-level review. Such removal of significant authority from individual ICs risks sacrificing the benefits derived from their specialized expertise at a critical early juncture. The NIH’s proposal is now under review with implementation pending external review, including by the Department of Health and Human Services and the Office of Management and Budget, providing Congress with a 15-day notification period, and issuing a Federal Register notice.

NIH updates categorization spending website

The National Institutes of Health (NIH) has issued information on recent updates to the Research, Condition, and Disease Categorization (RCDC) categorical spending webpage. According to NIH, “The new visual and contextual changes aim to improved usability and understanding of the RCDC categorization process. In particular, the categorical spending page was reorganized so data are more prominent and easier to navigate.” The RCDC was launched in 2008 as a tool within the Research Portfolio Online Reporting Tools (RePORT) and provides estimates of the annual support level for more than 300 research, condition, and disease categories based on grants, contracts, and other funding mechanisms used across the NIH, as well as disease burden data published by the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics.

CMS rescinds guidance on health-related social needs

The Centers for Medicare & Medicaid Services (CMS) has released a Center Informational Bulletin (CIB) rescinding guidance related to coverage of health-related social needs (HRSN). The bulletin rescinds two CIBs published in November 2023 and December 2024, both titled “Coverage of Services and Supports to Address Health-Related Social Needs in Medicaid and the Children’s Health Insurance Program,” as well as an accompanying document from November 2023 known as the “Framework of Coverage of HSRN Services in Medicaid and CHIP.” CMS has indicated that approved 1115 waivers and 1915(c) waivers that include HRSN provisions will not be affected. State applications to cover these services and supports will be considered on a case-by-case basis.

HHS OIG issues report on assessing nursing home emergency preparedness programs

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued the report “State Survey Agencies Need Additional Guidance to Assess Nursing Home Emergency Preparedness Programs” (full report and report highlights). In response to nursing home failures, such as resident deaths during disasters and emergencies, the HHS OIG assessed State survey agencies’ processes for overseeing nursing home emergency preparedness in accordance with the Centers for Medicare & Medicaid Services (CMS) Requirements for Participation. The report found that a quarter of State survey agencies reported challenges with surveyor emergency preparedness expertise; however, almost half of State survey agencies reported successes beyond CMS guidance. The report recommends that CMS provide surveyors with instructions on how to assess the contents of nursing home emergency preparedness documentation and issue guidance that encourages State survey agencies to collaborate and share information.

LEAD Coalition welcomes new member organizations

The LEAD Coalition recently welcomed the University of Chicago Healthy Aging & Alzheimer’s Research Care (HAARC) Center and the National Council of Dementia Minds (NCDM) as its newest member organizations.

The HAARC Center is a leading hub for aging and dementia research, focused on resilience, resistance, and promoting longer health spans. It conducts multidisciplinary studies, applies community-engaged research, and develops evidence-based interventions to advance care and knowledge. The HAARC Center leads the international SuperAging Research Initiative, studying adults aged 80+ with exceptional memory to uncover factors supporting cognitive resilience. The HAARC Center also addresses atypical dementias like Primary Progressive Aphasia (PPA) through the Communication Bridge Research Program, the first efficacious intervention which enhances communication and care strategies. The HAARC Center utilizes precision, cognitive, neuroimaging, and biomarker research to improve understanding of neurodegenerative diseases. The HAARC Center enrolls participants in its research registry and collaborates on large multisite initiatives, including serving as a Diversity Hub Site for the Alzheimer’s Disease Neuroimaging Initiative (ADNI). 

NCDM is proud to be the first national 501(c)(3) nonprofit organization founded and governed by persons living with dementia. NCDM includes individuals with all types of mild cognitive impairment or dementia, including younger-onset dementias. NCDM challenges societal stigmas along with offering hope-filled strategies and resources to support living well with dementia. NCDM’s mission comes to life through the following four program areas:

• Dementia Minds Groups. NCDM develops and sustains peer support groups that empower individuals with dementia to connect, share experiences, and support one another. NCDM also provides opportunities for people with dementia or mild cognitive impairment to come together in larger settings through NCDM “Meetings of the Minds.” 
• Educational Opportunities. NCDM offers interactive virtual programming tailored to audiences of individuals living with dementia, care partners, service providers, and other stakeholders. 
• Resources. NCDM develops and shares practical resources to enhance daily life and address real-world challenges that people with dementia face. 
• Lived Experience Expertise. Dedicated to ensuring that people with dementia have a powerful voice in both personal and public conversations, NCDM participates in co-researcher opportunities to impart its lived experience expertise.

Global CEOi launches Alzheimer’s blood test performance database for clinicians

The Global CEO Initiative on Alzheimer’s Disease (CEOi) has launched the Alzheimer’s Blood Test Performance Database, a first-of-its-kind resource designed to support clinicians and other healthcare decision makers in evaluating the performance of blood tests for Alzheimer’s disease. With a growing number of Alzheimer’s blood tests becoming available, clinicians need a simple way to assess which tools meet clinical standards. The Alzheimer’s Blood Test Performance Database addresses this critical gap – providing a clear, centralized view of how each test compares against performance standards recommended by CEOi’s expert Blood Biomarker (BBM) Workgroup. The database is built on data voluntarily submitted by companies offering Alzheimer’s blood tests in the U.S. All submissions follow a standardized format and are independently quality checked for consistency, clarity, and scientific rigor. The database will be updated regularly to ensure healthcare providers have the most current information on test performance. 

NAC releases policy brief on Medicaid and family caregiving

The National Alliance for Caregiving has released “Policy Brief: The Role of Medicaid in Supporting Family Caregivers.” The policy brief discusses how Medicaid has emerged as the primary source of support for family caregivers which enables individuals to receive care in their homes rather than nursing facilities. Medicaid provides direct financial support to family caregivers and supplemental services like respite care, training, and counseling to help families avoid or delay institutional care. The National Strategy to Support Family Caregivers recognizes Medicaid’s central role in supporting family caregivers. This policy brief reviews how policy affects family caregivers’ ability to maintain their own health and provide care for the people in their lives. Read the policy brief to learn more.

Among older women, hormone therapy linked to tau accumulation

Research published in Science Advances shows faster accumulation of tau—a key indicator of Alzheimer’s disease—in the brains of women over the age of 70 who took menopausal hormone therapy (HT) more than a decade before. While the researchers did not see a significant difference in amyloid beta accumulation, they did find a significant difference in how fast regional tau accumulated in the brains of women over the age of 70, with women who had taken HT showing faster tau accumulation in specific regions of the brain. This difference was not seen in women younger than 70. The study compared brain imaging from 73 women who had used hormone therapy an average of 14 years prior and 73 age-matched women who had not. Participants were between ages 51 and 89 at the beginning of the study. Participants had PET scans for amyloid beta over a mean 4.5-year period and for tau over a 3.5-year period. The authors note that they cannot definitively conclude whether the influence of chronological age is due to changes in guidelines on HT prescribing or simply due to a higher tau-PET signal typically observed at more advanced ages. Current clinical guidance is that HT should be initiated within 10 years following a woman’s age at menopause to avoid adverse effects.

Consumer digital devices can be used to assess brain health

A study published in Nature Medicine has found widely used consumer grade digital devices, such as the iPhone and Apple Watch, can be effective in assessing an individual’s cognitive health without requiring in-person visits or supervision. This is the largest cognition study of its kind to demonstrate that self-administered cognitive assessments can be leveraged to accurately assess cognitive health over time. The study enrolled more than 23,000 adults represented from across the U.S. who used an iPhone. Enrollment was broad and included individuals (from ages 21 to 86) raging from cognitively healthy to diagnosed with mild cognitive impairment. Of the participants enrolled, over 90% were able to adhere to the study protocol for at least one year, which included using an iPhone and wearing an Apple Watch on a daily basis, as well as taking cognitive assessments on their own and completing questionnaires on a monthly and quarterly basis. The researchers also found that self-administered digital cognitive assessments were reliable and clinically valid across the broad populations enrolled. The ability to accurately measure cognitive health remotely could be the first step in providing individuals with the information they need to take action on their brain health.

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February, 2025 News

NIH ADRD Summit postponed and transitioned to virtual-only format

Due to unforeseen circumstances, the NIH Alzheimer’s Disease Related Disorders (ADRD) Summit 2025 is being postponed; the tentative dates for the Summit now are April 29 and April 30. The Summit will be held exclusively as a virtual meeting. To register, click here. For assistance with your registration, please contact Rachael Heiner.

The ADRD Summits complement the Alzheimer’s Disease Research Summits, and the National Research Summits on Care, Services, and Supports. These summits are coordinated planning efforts that respond to the National Plan to Address Alzheimer’s Disease, first released in 2012 and now updated annually. The conferences set national research recommendations that reflect critical scientific priorities for research on Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD). 

The ADRD Summit 2025 will address research priorities for Alzheimer’s disease-related dementias, including frontotemporal degeneration, Lewy body, multiple etiology dementias, and vascular contributions to cognitive impairment and dementia, along with broader cross-cutting areas, including health equity. Significant portions of the Summit will be dedicated to public comment on the updated draft research recommendations. The Summit will conclude with a review of the highlights from the sessions and summary of the major themes from the public comments. Based on input received at the Summit, the recommendations will be revised and presented to the National Institute of Neurological Disorders and Stroke NINDS Council for approval. Approved recommendations will become research milestones in the National Plan to Address Alzheimer’s Disease.

House Labor-H Appropriations Subcommittee issues notice on public witness testimony

The House Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee (Labor-H), which has jurisdiction over National Institutes of Health (NIH) funding, has issued notices that it will hold a Members Day Hearing on March 5 and will hold a Public Witness Hearing on April 9 to discuss fiscal year (FY) 2026 appropriations. The Public Witness Hearing deadlines to submit requests to testify and/or offer written testimony for the record are March 21 and April 9, respectively.

In a related development, House Appropriations Committee Chair Tom Cole (R-OK) has issued a statement on continued FY 2025 appropriations negotiations, noting that top congressional appropriators “continue to work to move topline discussions and cooperation forward. Progress has been made since the start of the negotiations, and we remain engaged in good-faith discussions with the Senate and minority.” The statement followed a series of letters sent by Chair Cole to leadership of House authorizing committees urging coordination and a review of legislative priorities for the 119th Congress.

Paid Family and Medical Leave Tax Credit Extension and Enhancement Act re-introduced in Congress

The Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (see Senate text and summary) has been re-introduced by U.S. Senators Deb Fischer (R-NE) and Angus King (I-ME) and Representatives Rep. Marie Gluesenkamp Perez (D-WA), Randy Feenstra (R-IA) and Stephanie Bice (R-OK). The legislation would expand and reform the IRS Section 45S Employer Credit for Paid Family and Medical Leave (PFML)  – which was a two-year tax credit authorized by the Tax Cuts and Jobs Act of 2017 and later extended by Congress through the end of 2025 – for employers that voluntarily offer up to 12 weeks of PFML. The legislation builds on the 2017 law to better serve working families and hourly workers. It also provides additional ways for businesses to qualify for the paid leave tax credit, such as paying for PFML insurance products, and requires greater outreach efforts to raise awareness about the credit.

The legislation seeks to improve the 45S tax credit available to small businesses that provide PFML, expanding it to include PFML provided through an insurance company or in a state with a mandate. The legislation would reduce the minimum time a worker must be employed to claim the credit from one year to 6 months to more quickly support young employees who are starting their families and provide resources and outreach to help guide and educate small businesses about the use of the credit. According to the Bureau of Labor Statistics, more than 41 percent of employees at businesses with more than 500 employees have access to PFML while just 20 percent of workers at businesses with fewer than 99 employees have access to PFML.

HHS ASPE forecasts savings from Medicare Part D out-of-pocket cap

On January 13, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) Office of Health Policy published a report showing that about 11 million Medicare Part D enrollees are expected to reach the $2,000 out-of-pocket cap in 2025. These enrollees are projected to save $7.2 billion annually, for an average savings of $600 per enrollee. Average out-of-pocket savings are projected to be even higher for enrollees who do not receive financial assistance for their prescription drug costs — about $1,100 per enrollee. The report also contains state-based data showing the conditions and specific drugs with the highest Part D spending. For additional information, click here.

Justice in Aging provides Medicaid advocacy resources

As Congress considers proposals to restrict or cap federal Medicaid funding to states, Justice in Aging has developed resources to help advocates understand how these cuts would harm older adults. Medicaid is essential for people living with dementia, covering critical services that private insurance and Medicare do not cover, including long-term services and supports (LTSS), transportation, and respite for caregivers. Capping federal Medicaid spending would be devastating for individuals with dementia and their families, forcing states to restrict eligibility, cut benefits, and lower provider reimbursement—ultimately resulting in decreased enrollment and service access for people in need. Justice in Aging’s materials equip advocates with valuable information to defend Medicaid:

• Cutting Medicaid Harms Older Adults No Matter How It’s Sliced –This fact sheet provides an overview of the proposals Congress is considering and how each would cut care for older adults.
• How Medicaid Funding Caps Would Harm Older Adults – This issue brief outlines how proposals to cut Medicaid would shift financial liability to states, forcing states to slash services and enrollment, highlighting how Medicaid funding caps would harm the millions of older adults who rely on the program.
• Work Requirements Would Cut Medicaid Funding for Older Adults – This fact sheet provides data and stories to explain how — even though most people targeted by work requirements should remain eligible — bureaucratic hurdles associated with the policy will take away coverage from people already working, older adults who are retired or having difficulty finding work, people with disabilities, and family caregivers.
• Protecting Medicaid for Older Adults: What’s at Risk & What Advocates Can Do – This recorded webinar provides an overview of potential Medicaid cuts, how Congress can fast-track these changes, and key advocacy strategies and resources to help advocates mobilize and defend Medicaid in their states and communities.

FDA issues 2024 Drug Safety Priorities report

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released the Drug Safety Priorities Fiscal Year 2024 report. The report underscore CDER’s ongoing commitment to promote and protect public health by addressing potential medication risks and enhancing safety measures. The report highlights continuing initiatives to combat the overdose crisis, including the launch of a new campaign offering free training, mentoring, and resources for health care professionals prescribing medications for opioid use disorder. The report details efforts to prevent medication shortages and transparently relay information about recalls and medication safety information to the public. It also features the CDER’s robust safety monitoring program through Sentinel, work to enhance the quality of compounded medications, and partnerships to reduce medication-related harm. 

Interactive online tool helps consumers understand costs of Alzheimer’s disease self-care and medicines

Fair Health has launched a new Alzheimer’s disease shared decision-making tool featuring clinical information for self-care and drug therapy options, related cost information. and supplementary resources. Provided at no cost to users, these offerings are made available with support from the John A. Hartford Foundation. The online tools, educational content and resources on Alzheimer’s disease care also are available in Spanish. For additional details, read the Fair Health press release (English and Spanish).

“Flip the Script on Aging” during Older Americans Month

Each May, the Administration for Community Living (ACL) leads observances for Older Americans Month (OAM). The 2025 OAM theme is “Flip the Script on Aging,” which will focus on transforming how society perceives, talks about, and approaches aging. Throughout OAM, ACL and partnering organizations will honor older adults’ contributions, approaches for staying active and engaged, and highlight the opportunities for purpose, exploration, and connection that come with aging. For OAM 2025 resources, click here.

Milken Institute releases report on employer support for family caregivers

The Milken Institute Future of Aging has released a report, “Supporting Family Caregiving: How Employers Can Lead,” which highlights three essential strategies for organizations to support employees who are family caregivers:

• Flexible Work Arrangements: Offer adaptive schedules and remote work options to help caregivers manage responsibilities without sacrificing productivity.
• Caregiver-Specific Benefits: Implement policies such as paid caregiving leave (distinct from vacation or personal days), educational resources, employee support groups, and financial tools tailored to caregivers’ needs.
• Technology and Inclusive Cultures: Use technology-enabled caregiving platforms and foster workplace environments where employees feel comfortable identifying as family caregivers.

Organizations that prioritize caregiver support experience measurable benefits, including improved employee retention, higher engagement, and greater productivity. These efforts enhance workforce well-being and position organizations as leaders in an evolving talent landscape. 

AD/ADRD is chronically undiagnosed and early detection is underused

According the new research findings, “Older US adults’ experiences with and views about cognitive screening and blood biomarker testing for Alzheimer’s disease,” despite the potential benefits of early detection and increasing treatment options for Alzheimer’s disease and related dementias, there is limited use of valuable screening and testing tools. Researchers at the University of Michigan School of Public Health and Michigan Medicine studied responses from nearly 1,300 participants in the National Poll on Healthy Aging—a large, nationally representative survey of older adults—to understand experiences and views of cognitive screening and blood biomarker testing among adults aged 65-80. Consistent with previous research, their study found that only about 1 in 5 older Americans reported having cognitive screening in the past year, with such rates lower among certain racial and ethnic minority groups (i.e., Hispanic, Asian American). More than 6.5 million people in the United States have Alzheimer’s disease or a related dementia, a number projected to double by 2060, according to the Alzheimer’s Association. The study showed that a majority of older Americans are aware of the upsides of early detection— earlier treatment and emotional support, financial and legal planning, care coordination and more. Even with recognition of potential benefits and Medicare coverage of cognitive testing for beneficiaries, the underuse of cognitive screening persists. Millions of dementia cases go undiagnosed and untreated, fueled by multiple barriers to diagnosis at the patient, provider and health care system levels, which the study details.

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January, 2025 News

FDA approves Leqembi IV maintenance dosing for the treatment of early AD

The U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks LEQEMBI® (lecanemab-irmb) intravenous (IV) maintenance dosing for the treatment of patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. After an initial 18 months phase of once every two weeks dosing, a transition to the maintenance dosing regimen every four weeks may be considered (or the regimen of once every two weeks may be continued). The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301) and its LTE study. Modeling simulations predict that transitioning to once every four weeks maintenance dosing after 18 months of once every two weeks treatment will maintain clinical and biomarker benefits of therapy. For additional details, read the full press release and a Neurology Live article.

CMS launches national nursing home staffing recruitment campaign

The Centers for Medicare & Medicaid Services (CMS) has launched a national nursing home staffing campaign to help recruit more nurses to work in nursing homes and state survey agencies that inspect nursing homes for compliance with health and safety standards. CMS will partner with state governments to leverage the foundation CMS is building to bolster the campaign in their state. CMS also will collaborate with various interested parties, such as resident advocates, nursing organizations, and nursing home associations to strengthen the campaign by amplifying recruitment messages and promoting incentives to work in nursing homes. The CMS “Explore Nursing Home Careers” website highlights nursing home career pathways and provides information on becoming a certified nursing assistant (CAN) at no cost. For additional information and updates, click here.

GAO report on Older Americans Act programs finds overlap, but no duplication, with other federal programs 

In fiscal year 2024, Older Americans Act (OAA) services received approximately $2.4 billion in congressional appropriations. These services exist alongside other federal programs that provide social services for older adults. The U.S. General Accounting Office (GAO) regularly reports on federal programs with potentially fragmented, overlapping, or duplicative efforts, with the goal of improving the efficiency and effectiveness of government. GAO was asked by Congress to review potential duplication between programs authorized under the OAA and federal programs authorized under other laws. The newly published GAO report determined that OAA services and assistance overlap — but do not duplicate — those available under 36 other federal programs. GAO found that these programs differ in the population served, goals and services provided, or both. The overlapping programs can complement OAA-funded services, for example by providing more specialized services relevant to an agency’s expertise. The areas of need served by these programs include health, nutrition, transportation, and employment. Nine departments and agencies administer the 36 non-OAA programs, which indicates there is fragmentation of services for older adults. 

The U.S. Department of Health and Human Services (HHS), Administration for Community Living (ACL), which administers most OAA programs, is taking steps to manage fragmentation by coordinating with other federal agencies that serve older adults. Coordination among federal agencies can enhance complementary efforts and mitigate potential negative effects of fragmentation. ACL acts as the lead agency of the Interagency Coordinating Committee on Healthy Aging and Age-Friendly Communities (Coordinating Committee), which began work in 2023 after receiving initial funding. The Coordinating Committee is composed of 18 federal agencies — including the Departments of Agriculture, Labor, Transportation, and Housing and Urban Development — which have taken initial steps to work together to avoid duplicative work and leverage resources. Last May, the Coordinating Committee published a strategic framework as a basis to develop a national set of recommendations to advance healthy aging and age-friendly communities for older adults. The Coordinating Committee is in the process of further developing strategic goals, in part, by hosting listening sessions that include older adults. GAO has identified leading practices for effective interagency collaboration, including defining common outcomes and ensuring accountability, which could inform ACL’s work with the Coordinating Committee. Incorporating these practices could increase the effectiveness of the coordination in managing fragmentation of services.

Elizabeth Dole Home and Community Based Services for Veterans and Caregivers Act signed into law

President Biden has signed into law the Elizabeth Dole Home and Community Based Services for Veterans and Caregivers Act (S. 141/H.R. 542; P.L. 118-210), which improves and expands home and community-based services (HCBS) provided by the Department of Veterans Affairs (VA) for disabled and older veterans, including those living with Alzheimer’s disease and other forms of dementia. Under the bill, the cost of providing non-institutional alternatives to nursing home care may not exceed the cost that would have been incurred if a veteran had been furnished VA nursing home care, unless the VA determines that a higher cost is in the best interest of the veteran. Under previous law, these expenditures were limited to 65% of the cost. Among other requirements, the VA must:

• establish a partnership with the Program of All-Inclusive Care for the Elderly (PACE) in certain areas to furnish non-institutional alternatives to nursing home care;
• implement various programs (e.g., the Veteran Directed Care program) to expand access to HCBS;
• provide specified support and benefits to caregivers of certain disabled veterans;
• implement a pilot program to provide homemaker and home health aide services to veterans who reside in communities with a shortage of home health aides; and
• ensure the availability of HCBS for Native American veterans.

For veterans or family caregivers who are discharged from the Program of Comprehensive Assistance for Family Caregivers, a caregiver support coordinator must provide for a personalized transition to an appropriate program. The Veterans Health Administration must review programs administered through the Office of Geriatric and Extended Care to ensure consistency in program management, eliminate service gaps at the medical center level, and ensure the availability of and access to HCBS.

A new report from the National Academies of Sciences, Engineering, and Medicine identifies research priorities that the National Institutes of Health (NIH) should pursue over the next three to 10 years to advance the prevention and treatment of Alzheimer’s disease and related dementias (AD/ADRD). 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 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

The research priorities identified by the report are not focused on individual dementia types. Instead, they emphasize research opportunities that would apply across the spectrum of AD/ADRD and respond to the high prevalence of mixed etiologies dementia (MED). NASEM also has published highlights summarizing the full report.

FDA begins consideration of BLA for Leqembi subcutaneous maintenance dosing

The U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for Leqembi (lecanemab-irmb) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved by the FDA, Leqembi would be the first maintenance dosing treatment for AD that can be administered at home using SC-AI. The injection process is expected to take 15 seconds on average. As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that are expected to maintain the clinical and biomarker benefits. FDA is expected to issue a decision no later than the August 31 Prescription Drug User Fee Act (PDUFA) action date. 

ADvancing States IQ offers updated introductory course on elder abuse

In partnership with the National Center on Elder Abuse (NCEA), ADvancing States is offering a fully updated online training course, “An Introduction to Elder Abuse,” available on ADvancing States IQ in the course category Preventing Abuse and Exploitation. Course materials define, distinguish, and explain the significance and impact of elder abuse, as well as offer strategies to respond to possible scenarios. The course is designed for individuals in the fields of aging and disabilities who may encounter elder abuse or vulnerable adult abuse situations. Key topics covered in this course include elder abuse, aging and ageism, risk and protective factors, impacts and consequences, and responses and resources. 

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