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)

Official funding announcement — preliminary draft

Funder: National Institutes of Health

Opportunity number: PAR-25-226

Official listed status: posted

Closing information: 2026-11-19 (official deadline clock time and time zone must be checked in NOFO)

Award disclosure: Applicant-level ceiling not stated in the retrieved federal synopsis; verify in full NOFO.

Applicant categories in federal synopsis: Small businesses; Public housing authorities/Indian housing authorities; Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; 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; For profit organizations other than small businesses; County governments; Native American tribal organizations (other than Federally recognized tribal governments); City or township governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public and State controlled institutions of higher education; State governments; Special district governments

Federal 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.

Draft intake record. Eligibility, program terms, current amendments and applicant ceiling must be independently verified before publishing.

Official Grants.gov opportunity and NOFO