Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
Funds pre-clinical and early Phase I development of novel small-molecule or biologic drug candidates for Alzheimer’s disease, including IND-enabling studies and initial clinical testing.
⚑ Foreign organizations are not eligible to apply. · Non-domestic components of U.S. organizations are eligible; foreign components are allowed. · Clinical trials are optional and limited to initial Phase I testing; stand-alone clinical trials are not responsive.
Unit fits — one characterization, each unit's own rules
| Physical Sciences & Engineering (demo) | 55 good | technical depth: minor; funds applied research |
| IPPRA | 45 partial | peripheral portfolio topic: public_health; social/behavioral work is none; funds applied research; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped); capped at 45 (limited social-science role) |
| Tom Love Innovation Hub | 45 partial | funds applied research; prototyping/demonstration stage; deep-tech content |
Description
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.
Eligibility
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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
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