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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 · Opportunity PAR-25-226

Deadline November 19, 2026 71 days left
Award range Not stated
Total program funding
PostedNovember 22, 2024

Who can apply

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.

About this opportunity

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.

Award history — this exact opportunity

NIH RePORTER lists 3 funded awards under PAR-25-226 across 3 organizations.

Awards by fiscal year 2026: 3
Award size (min / median / max) $1.5M / $2.6M / $3.3M

Total award obligations, not per-year amounts.

Recent awardees include: BRIGHAM AND WOMEN'S HOSPITAL, WEILL MEDICAL COLL OF CORNELL UNIV, ARTERY THERAPEUTICS, INC..

Source: NIH RePORTER, matched on the exact opportunity number. NIH publishes success rates by institute and activity code — source.

Portfolio context — this listing covers more than this opportunity

This opportunity is funded under Assistance Listing 93.242 (“Mental Health Research Grants”), a broad federal program that made about 863 new awards per year over the last five fiscal years (median award $552k). Those figures describe that whole portfolio — not this specific solicitation, so we don't show them as if they were this opportunity's track record.

Applicant counts per solicitation are not published by any federal agency — no one can honestly sell you that number. NIH publishes success rates by institute and activity code — source.

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