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

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 activities such as high throughput screening and hit optimization.
Related Programs

Aging Research

Department of Health and Human Services

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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.

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