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

By National Institutes of Health
Government Grant





The goal of this Funding Opportunity Announcement (FOA) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic therapeutic agents 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, formulation development, chemical synthesis under Good Manufacturing Practices (GMP), Investigational New Drug (IND) enabling studies and initial Phase I clinical testing. This program does not support research on basic mechanisms of disease, mechanisms of drug action, development of biomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combinations therapies, or discovery acti...


  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • 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
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others

Thanks to the funder for their generosity.