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)

Funder: National Institutes of Health
Award amount: Not specified
Deadline: November 19, 2026
Eligible countries: United States

Summary

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.

Summary as listed on Grants.gov (opportunity 357343). Always read the full announcement for eligibility, limits and how to apply.

Read the full announcement on Grants.gov →

What National Institutes of Health reviewers look for

Importance of the research (significance and innovation), scored 1–9.
Rigor and feasibility of the approach, scored 1–9. Preliminary data and alternative strategies carry much of this.
Expertise and resources, rated sufficient or not, without a score.
Overall impact: the likelihood the project will have a sustained, powerful influence on its field.

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