Sign onto the LEAD Coalition’s letter to Congress regarding FY2027 appropriations

The LEAD Coalition invites organizations and university-affiliated researchers to become signatories on its Fiscal Year 2027 (FY2027) appropriations letter to Congress. Signatories do not need to be LEAD Coalition members. On behalf of the seven million Americans who live with dementia and their 12 million unpaid family caregivers, along with all Americans who are at risk for developing dementia in the coming decades, the letter urges Congress to reassert the country’s non-partisan priority to overcome Alzheimer’s and related disorders (AD/ADRD) by making robust appropriations for relevant federal agencies and ensuring complete and timely expenditure of those funds for Congressionally-designated purposes. Federal entities include: 

• Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (HHS ASPE)
• National Institutes of Health (NIH) 
• Centers for Disease Control and Prevention (CDC) 
• Administration for Community Living (ACL) 
• Health Resources and Services Administration (HRSA) 
• Agency for Healthcare Research and Quality (AHRQ)
• Food and Drug Administration (FDA)
• Centers for Medicare and Medicaid Services (CMS) 
• Department of Justice (DOJ) 

Action opportunity: Please use either the organizations sign-on form or the university-affiliated researchers sign-on form to join the LEAD Coalition letter by the April 10 deadline.

Provide input on a proposed framework for NIH’s next five-year strategic plan

The National Institutes of Health (NIH) is inviting input on a proposed framework for its next five-year strategic plan, which will cover fiscal years (FY) 2027 through 2031. The NIH-Wide Strategic Plan communicates how NIH will advance its mission to support research in pursuit of fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. 

The Framework for the NIH-Wide Strategic Plan for FY27-FY31 articulates NIH’s priorities in three key areas: 

• Priority 1: Research Areas
  • Goal 1: Advance Foundational Knowledge of Human Health and Disease
  • Goal 2: Prevent Disease and Promote Health Across the Lifespan
  • Goal 3: Advance and Optimize Interventions, Treatments, and Cures
• Priority 2: Research Capacity
  • Goal 1: Develop and Sustain an Interdisciplinary Research Workforce
  • Goal 2: Build, Improve, and Sustain Research Resources and Infrastructure
• Priority 3: Research Operations
  • Goal 1: Enhance Scientific Stewardship and Decision-Making
  • Goal 2: Foster Transparency and Accountability to Improve Public Trust in Science

Action Opportunity: Interested parties throughout the scientific research, advocacy, and clinical practice communities, as well as the general public, are encouraged to submit electronic responses using this form by May 26 deadline.

Submit a proposal for the new MAHA ELEVATE model 

The Centers for Medicare and Medicaid Services (CMS), through its Centers for Medicare and Medicaid Innovation (CMMI or Innovation Center), is soliciting applications for the MAHA ELEVATE model. MAHA ELEVATE, which stands for Making America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence, is the first Innovation Center model to focus on holistic, patient-centered functional or lifestyle medicine approaches that include nutritional and/or physical activity interventions along with other psychological or self-care strategies to address the whole person rather than individual disease. The model is envisioned as a three-year service delivery model and is expected to provide critical data to inform future Medicare coverage determinations or potential future CMS Innovation Center models designed to improve the health of beneficiaries and reduce health care costs. It also is expected to provide a critical evidence base needed to determine how lifestyle interventions best can be incorporated into care for older populations. CMS plans to award up to thirty 3-year cooperative agreements up to a combined total of $100 million.

Action Opportunity: Interested organizations are invited to submit a mandatory Letter of Intent by April 10. Applications for the first cohort of recipients are due on May 15 and the model will launch in October.

Submit public comments on FDA draft guidance for patient preference studies

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “E22 General Considerations for Patient Preference Studies” (FDA-2026-D-0207). When finalized, this guidance is expected to provide general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development.. 

Action Opportunity: LEAD Coalition member and allied organizations are encouraged to review the draft guidance and provide comments via the Federal Register (FDA-2026-D-0207) by the April 7 deadline.

Provide input on the FDA Commissioner’s National Priority Voucher pilot program

The U.S. Food and Drug Administration (FDA) is seeking public comment on the Commissioner’s National Priority Voucher (CNPV) pilot program (FDA-2026-N-2366). The CNPV pilot program was established in June 2025 to reduce review times for qualifying new drug applications (NDAs), biologics license applications (BLAs), and manufacturing or efficacy supplements through enhanced regulatory engagement and streamlined review procedures. So far, the agency has awarded vouchers for 18 products and granted four approvals. In addition to accepting written feedback, the agency will host a public hearing on June 12 to seek input about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.

Action opportunity: Interested parties are encouraged to attend the June 12 public hearing and/or submit written comments by the June 27 deadline. Details about meeting registration, including requests for participation, can be found here; written comments can be submitted via the Federal Register.

Submit feedback to NIH on return of results to research participants

The Office of Science Policy (OSP) at the National Institutes of Health (NIH) is undertaking a comprehensive policy development process to establish requirements tied to the responsible return of summary-level study results to research participants for all NIH-funded clinical research. Public input is vital to ensuring NIH develops a policy that is flexible, forward-thinking, and serves the best interest of the research participants and the researcher community. NIH is interested in understanding what information should be included in the summary-level results, best practices for participant engagement to ensure that results are returned in meaningful ways, and the timing of sharing summary level results. 

Action opportunity: Interested parties – including study participants, researchers, clinicians, and the broader public— are encouraged to provide feedback to NIH OSP via the available form to help shape the future return of results policy. Feedback is also being sought via a webinar on April 27; individuals can register to attend the webinar here.

Respond to NIH RFI on drug development to prevent or treat specific aging-related conditions

The National Institute on Aging (NIA) has released a request for information (RFI; NOT-AG-26-001) on the development of disease-modifying drugs to prevent or treat specific aging-related conditions. There is evidence that some biologic mechanisms contribute both to physiologic aging changes and to specific aging-related conditions, but few drugs expressly target these mechanisms to modify such conditions.

The RFI seeks input from academic and industry stakeholders who have identified relevant therapeutic targets or are actively developing such drugs. Responses to the RFI will aid NIA in assessing the extent to which potential mechanistic targets for interventions have been identified and validated and will inform planning for possible drug development research initiatives.

Action Opportunity: LEAD Coalition member organizations and allies are encouraged to submit comments to NIA_DrugDevelopment@NIH.gov by the July 1 deadline.

Apply to ADDF and AFTD joint funding opportunities on FTD research 

The Alzheimer’s Drug Discovery Foundation (ADDF) and the Association for Frontotemporal Degeneration (AFTD) jointly announced two new funding opportunities focused on research for frontotemporal degeneration (FTD).

• The Treat FTD Fund aims to support the development of drugs or devices for FTD disorders while building a better understanding of FTD pathophysiology, biological mechanisms of disease, and analytically and clinically validated biomarkers with a well-defined context-of-use. This request for funding proposals (RFPs) supports novel or repurposed drug candidates or devices in early-stage (phase 0, 1, or 2) clinical trials for FTD disorders. The award will be up to $2,500,000 over one to three years. 
• The Accelerating Drug Discovery for FTD intends to support innovative small molecule and biologic drug development programs for FTD, either in lead optimization or in vivo testing of novel lead compounds, biologics, vaccines, or repurposed drug candidates. Funding is open to academic researchers or biotechnology companies worldwide. The average one-year award is expected to be $300,000, based on stage and scope of research. 

Action Opportunity: Researchers and biotech companies worldwide are encouraged to apply to these funding opportunities. For the Treat FTD Fund opportunity, a Letter of Intent (LOI) is due by March 30 and a full proposal is due by June 1. For the Accelerating Drug Discovery of FTD opportunity, the LOI deadline is May 11 and invited full proposals are due by July 20.

Apply to Phase 1 of ACL’s Caregiver AI Prize Competition 

The Administration for Community Living (ACL) has announced the launch of Phase 1 of the Caregiver AI Prize Competition, a national challenge designed to support caregivers and the caregiving workforce through responsible uses of artificial intelligence (AI). In Phase 1, participants will compete for up to 20 awards, totaling $2.5 million in prize funding. Funding is intended to support the transformational uses of AI, including delivering on-demand support and training, monitoring well-being, and automating processes and documentation. The competition includes two tracks, which will run simultaneously:

• Track 1: AI caregiver tools that support family, friends, and/or the direct care workforce in providing safe, person-centered care at home.
• Track 2: AI caregiver workforce tools to help home care organizations improve. 

Action Opportunity: Interested parties are encouraged to attend an informational webinar about the Caregiver AI Prize Competition on March 11.  Teams are required to submit an Intent to Apply by April 15 via email to CaregiverAI@acl.hhs.gov, and submit an application by July 31.

Urge Members of Congress to co-sponsor dementia-specific legislation

Alzheimer’s Screening and Prevention (ASAP) Act

Congressmen Vern Buchanan (R-FL) and Paul Tonko (D-NY), and Senators Susan Collins (R-ME) and Catherine Cortez Masto (D-NV), have introduced the Alzheimer’s Screening and Prevention (ASAP) Act (H.R. 6130/S.3267). This bipartisan legislation aims to ensure timely access to innovative screening tests that can detect Alzheimer’s disease and related forms of dementia in their earliest stages.

Under current law, Medicare can cover only preventive services that Congress has specifically authorized or that are recommended by the U.S. Preventive Services Task Force (USPSTF). This process can delay coverage for years after screening tests receive Food and Drug Administration (FDA) approval. The ASAP Act modernizes that process by authorizing the Secretary of Health and Human Services to provide Medicare coverage for FDA-approved or cleared blood-based biomarker tests for the early detection of Alzheimer’s and other dementias. For more information about the ASAP Act, read the Alzheimer’s Impact Movement press release, ASAP Act Fact Sheet, and the joint LEAD Coalition/Alzheimer’s Association/AIM letters to Congress encouraging all Representatives and Senators to become co-sponsors.

Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act

Senators Shelley Moore Capito (R-WV) and Mark Warner (D-VA) have reintroduced the Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act, bipartisan legislation to encourage early assessment and diagnosis of Alzheimer’s. Companion legislation was also introduced in the U.S. House of Representatives by Representatives Linda T. Sánchez (D-CA), Darren LaHood (R-IL), Doris Matsui (D-CA), and Gus Bilirakis (R-FL). The CHANGE Act (S. 1799 / H.R. 3501) would better utilize the existing Welcome to Medicare initial exam and Medicare annual wellness visits to screen, detect, and diagnose Alzheimer’s 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. For additional information, see the bill text and the and the LEAD Coalition letters to Congress encouraging all Representatives and Senators to become co-sponsors.

Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act

Representatives Troy Balderson (R-OH), Nanette Barragán (D-CA), Darin LaHood (R-IL) and Paul Tonko (D-NY) and Senators Shelley Moore Capito (R-WV), Amy Klobuchar (D-MN), Jerry Moran (R-KS), Cory Booker (D-NJ), Dan Sullivan (R-AK), Andy Kim (D-NJ), James Lankford (R-OK), and Maria Cantwell (D-WA) have reintroduced the bipartisan Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act (H.R. 3747/S.4036). The AADAPT Act would provide grants to providers participating in structured Alzheimer’s and dementia virtual education programs to build on their knowledge of detection, diagnosis, care, and treatment of Alzheimer’s and other forms of dementia. The legislation would address knowledge gaps and workforce capacity issues being faced by primary care providers across the nation, connecting their practices with dementia care experts using free, remote continuing education. These programs have added importance in reaching rural and medically underserved areas where primary care providers are especially strained. Read the full legislative text.

Bridging Relief in Delayed Government Enrollment (BRIDGE) for Young Onset Alzheimer’s Disease Act

The Bridging Relief in Delayed Government Enrollment (BRIDGE) for Young Onset Alzheimer’s Disease Act of 2025 (H.R. 6799) would provide more timely coverage of treatment and care for individuals living with young-onset Alzheimer’s by removing the 29-month waiting period for individuals under the age of 65 to qualify for Medicare after obtaining Social Security Disability Insurance. For more information, please see the one-pager.

Global Alzheimer’s Initiative Now (GAIN) Act

Representatives Ami Bera (D-CA), Brian Fitzpatrick (R-PA) and Young Kim (R-CA) have reintroduced the bipartisan Global Alzheimer’s Initiative Now (GAIN) Act (H.R.3674). The GAIN Act would authorize the United States to participate formally in the Davos Alzheimer’s Collaborative (DAC), a global public–private–patient partnership advancing Alzheimer’s and dementia research, diagnosis, treatment, and care. Alzheimer’s and dementia affect nearly 60 million people globally and cost the world economy more than $1.3 trillion annually—an amount that doubles every decade. DAC aims to raise and deploy $700 million over six years and currently supports 19 health systems in 12 countries, including the United States. Read the full legislative text.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of these important pieces of legislation. 

Support the Geriatrics Workforce Improvement Act

U.S. Senators Susan Collins (R-ME) and Tim Kaine (D-VA) have introduced the Geriatrics Workforce Improvement Act (S.2699) to reauthorize funding for the Geriatrics Workforce Enhancement Program (GWEP) and the Geriatrics Academic Career Awards (GACA). Both programs were last authorized in 2020 as part of the CARES Act and are set to expire at the end of September, 2025. The Geriatrics Workforce Improvement Act would reauthorize the GWEP and GACA programs at a combined $48.2 million per year over the next five years.

The GWEP is the only federally funded program that exists to educate and train health professionals in geriatrics. There are currently 42 GWEP recipients. GACA support early-career training of junior faculty to develop emerging leaders in geriatric education and clinical care. There are currently 25 GACA recipients funded under four-year awards through June of 2027.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Geriatrics Workforce Improvement Act.

Support the Older Americans Act (OAA) Reauthorization Act

The Older Americans Act (OAA) Reauthorization Act (S.2120) has been reintroduced in the Senate by Senators Bill Cassidy (R-LA), Bernie Sanders (I-VT), Rick Scott (R-FL), Kirsten Gillibrand (D-NY), Susan Collins (R-ME), Tim Kaine (D-VA), Markwayne Mullin (R-OK), Edward Markey (D-MA), Lisa Murkowski (R-AK), and Ben Ray Luján (D-NM).. The legislation would renew funding and strengthens services for American seniors. Senator Collins is an original cosponsor of the bill, and she was a member of the bipartisan working group that authored this legislation. Since 1965, the OAA has supported and improved the lives of seniors—particularly those who are low-income—through programs that promote nutrition, improve transportation options, support caregivers, offer employment and community service opportunities, and prevent abuse and neglect. This critical law was last reauthorized in 2020.

Specifically, this legislation would reauthorize OAA programs through Fiscal Year 2030 and make improvements to promote innovation and flexibility, strengthen program integrity, and better support family caregivers and direct care workers. The bill also takes steps to better serve Tribal seniors and those with disabilities in their communities. The OAA authorizes an array of services through a network of 56 State Units on Aging and more than 600 Area Agencies on Aging serving older Americans throughout the nation. In the last year alone, OAA programs served more than 12 million caregivers and older adults, including providing more than 2.4 million seniors with at-home or congregate meals.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Older Americans Act (OAA) Reauthorization Act.

Support the Lifespan Respite Care Reauthorization Act

Senators Susan Collins (R-ME) and Tammy Baldwin (D-WI) have introduced the Lifespan Respite Care Reauthorization Act of 2025, bipartisan legislation to support the health and wellbeing of family caregivers. The legislation would reauthorize, at $50 million over five years, the Administration on Community Living (ACL) Lifespan Respite Care Program, which provides critical short-term relief to unpaid caregivers. Companion legislation was introduced by Representatives Nick Langworthy (R-NY) and Jill Tokuda (D-HI), which would reauthorize the program through fiscal year 2029. Both versions of the bill (S.830 / H.R. 2560) broaden the definition of a family caregiver, replacing “unpaid adult” with “unpaid individual.” As an essential component of home- and community-based long-term services, these respite services contribute to healthier families and the health and well-being of caregivers and care recipients. For additional information, see the Senate bill text and this letter of support.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Lifespan Respite Care Reauthorization Act of 2025.