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)
OpenNational Institutes of Health · Opportunity number PAR-25-226
Eligibility
Nonprofits are listed as eligible applicants.
- Native American tribal organizations (other than Federally recognized tribal governments)
- Private institutions of higher education
- Native American tribal governments (Federally recognized)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Special district governments
- City or township governments
- Public housing authorities/Indian housing authorities
- State governments
- Small businesses
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Independent school districts
- County governments
- For profit organizations other than small businesses
- Public and state controlled institutions of higher education
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.
Description
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.
Funding
| Total program funding | Not listed |
|---|---|
| Award floor | Not listed |
| Award ceiling | Not listed |
| Category | Health |
| Assistance listing | 93.242, |
Official sources
Last verified on Grants.gov Nov 4, 2026. Grantvello is not affiliated with Grants.gov or National Institutes of Health. The notice on Grants.gov is the binding text.