PAR-25-297-Full-Announcement.html

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Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
Opportunity number
PAR-25-297
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This Notice of Funding Opportunity (NOFO) PAR-25-297, issued by the Department of Health and Human Services National Institutes of Health, provides funding for pre-clinical and early stage clinical development of novel drug candidates for Alzheimer's disease (AD). The opportunity falls under the Aging Research grant program (CFDA 93.866) and is structured as a U01 cooperative agreement that is open to various applicant types including non-profits, for-profit organizations, educational institutions, government entities, and tribal organizations.

The funding supports specific therapy development activities including medicinal chemistry, pharmacokinetics, ADMET studies, animal model efficacy testing, biomarker development, GMP chemical synthesis, IND enabling studies, and Phase I clinical trials. Notable exclusions include basic disease mechanism research, biomarker development, devices, non-pharmacological interventions, repurposed drugs, combination therapies, high-throughput screening, and stand-alone clinical trials. The opportunity focuses specifically on novel small-molecule and biologic drug candidates that can prevent AD, slow its progression, or treat its cognitive and behavioral symptoms.

PAR-25-297 Full Announcement Text

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PKG00289419.pdf PDF

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