Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-226
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Independent School Districts
- Public or Indian Housing Auth.
- Other
- Non-501(c)(3) Nonprofits
- Tribal Governments (Federally Recognized)
- Higher Education Inst. (Private)
- County Governments
- Tribal Organizations (Not Federally Recognized)
- Special District Governments
- 501(c)(3) Nonprofits
- For Profit Organizations
- City/Township Governments
- Small Businesses
- State Governments
- Higher Education Inst. (Public)
- Points of contact
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- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health seeks applications for seamless early-stage clinical drug development bundling phase 1 and phase 1b/2a clinical trials for novel therapeutic agents addressing Alzheimer's disease and Alzheimer's disease-related dementias (ADRD), with applications due November 19, 2026. Candidate interventions must engage non-amyloid/non-tau mechanisms and target cognitive and/or neuropsychiatric symptoms across the disease spectrum from pre-symptomatic to severe stages. Proposals must include prespecified, go/no-go safety and tolerability milestones gating advancement from phase 1 to later clinical development stages.
Eligible applicants include higher education institutions (public and private), for-profit organizations, 501(c)(3) and non-501(c)(3) nonprofits, small businesses, state and local governments, tribal governments (federally recognized and other), independent school districts, special district governments, public or Indian housing authorities, Alaska Native and Native Hawaiian serving institutions, Hispanic-serving institutions, historically Black colleges and universities, tribally controlled colleges and universities, Asian American Native American Pacific Islander serving institutions, faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic entities, and U.S. territories or possessions.
The program uses the UG3/UH3 phased award mechanism, a cooperative agreement instrument. Support is recommended for a project period not exceeding 5 years. Applications are evaluated for scientific and technical merit by peer review panels and reviewed by the National Advisory Mental Health Council; all competitive applications compete on the basis of scientific and technical merit, program relevance, and program balance. The program operates under CFDA 93.242 (Mental Health Research Grants) within the National Institute of Mental Health.
Synopsis
The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development.
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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-226-Full-Announcement.html | HTML file | |
| PKG00288961.pdf |
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