Grants.govNational Institutes of Health

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)

Posted Nov 22, 2024·open

AGENCY

HHS-NIH11

PROGRAM

Discretionary

AMOUNT

—

CLOSES

Nov 19, 2026

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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.

Eligibility

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Independent school districts; Others (see text field entitled "Additional Information on Eligibility" for clarification); Special district governments; Public and State controlled institutions of higher education; For profit organizations other than small businesses; Private institutions of higher education; City or township governments; State governments; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Native American tribal governments (Federally recognized); County governments; Public housing authorities/Indian housing authorities; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

Contact

National Institutes of Health

grantsinfo@nih.gov

301-402-2541

Additional details

Funding instrument: Cooperative Agreement
Cost sharing required: No
Archived: Dec 25, 2026

Opportunity number: PAR-25-226

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