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Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)

Federal funding opportunity PAR-25-297 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes November 5, 2027

Posted: December 4, 2024
Closes: November 5, 2027
Award ceiling: $1,500,000
Cost sharing: No
Instrument: Cooperative Agreement
Assistance listing: 93.866
Category: Health
Archives: December 11, 2027

Program funding history

Awards made under Assistance Listing 93.866 across FY2024–FY2026, from public federal spending records.

FY2024 obligated: $3.8B
FY2025 obligated: $3.9B
FY2026 (to date) obligated: $2.4B
Awards in window: 12,121

Top recipients: Regents of the University of Michigan, Regents of the University of California, San Francisco, the, Washington University, the, The Trustees of Columbia University in the City of New York, University of Southern California

Source: USAspending.gov · refreshed August 2026

Synopsis

The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials.

Who can apply

Public housing authorities/Indian housing authorities
City or township governments
For profit organizations other than small businesses
Private institutions of higher education
County governments
State governments
Special district governments
Public and State controlled institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Independent school districts
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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