Alzheimer's Drug-Development Program (U01)

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The goal of this Funding Opportunity Announcement (FOA) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development ofsmall-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, 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.

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