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Federal Open GRANTS-GOV-357343

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)

National Institutes of Health (NIH) · Competitive · Science & Technology

At a glance

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) is a federal competitive grant from National Institutes of Health for the science & technology sector. Funding is up to $1B. Eligible applicants: Independent school districts; City or township governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); For profit organizations other than small businesses; Special distri. The application deadline is November 19, 2026. Apply via the official listing at www.grants.gov.

Amount
Up to $1B
Deadline
Nov 19, 2026
Type
Competitive
Status
Open

About this program

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.

Who can apply

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

How to apply

Apply through Grants.gov using funding opportunity number PAR-25-226. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source