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)
This grant supports combined Phase 1/2a clinical trials testing new drugs (excluding amyloid/tau targets) for Alzheimer's, using a milestone-driven approach.
Funder: National Institutes of Health
Due Dates: June 23, 2025 (New) | July 23, 2025 (Renewal/Resubmission/Revision) | October 20, 2025 (New) | November 20, 2025 (Renewal/Resubmission/Revision) | February 20, 2026 (New) | March 20, 2026 (Renewal/Resubmission/Revision) | June 22, 2026 (New) | July 22, 2026 (Renewal/Resubmission/Revision) | October 19, 2026 (New) | November 19, 2026 (Renewal/Resubmission/Revision)
Funding Amounts: No budget limit; project period up to 2 years (UG3) + up to 3 years (UH3), max 5 years total.
Summary: Supports milestone-driven, combined Phase 1/2a clinical trials of novel drugs (excluding amyloid/tau targets) for Alzheimer's disease and related dementias.
Key Information: Applications must bundle both UG3 (Phase 1) and UH3 (Phase 2a) activities and include go/no-go safety milestones; definitive efficacy (Phase 3) trials are not eligible.
Description
This opportunity from the National Institutes of Health (NIH), led by the National Institute on Aging (NIA), funds seamless early-stage clinical drug development for novel therapeutic agents targeting Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD). The program is designed to accelerate the evaluation of promising pharmacological interventions—specifically those that engage non-amyloid/non-tau mechanisms and address cognitive and/or neuropsychiatric symptoms across the full spectrum of disease, from pre-symptomatic to severe stages.
The funding mechanism (UG3/UH3) supports a bundled approach: applicants must propose both Phase 1 and Phase 1b/2a clinical trials in a single application, with clear, prespecified safety and tolerability milestones that determine progression from Phase 1 (UG3) to Phase 2a (UH3). The goal is to streamline early-stage clinical development and generate data to inform further clinical advancement of novel or repurposed drugs for AD/ADRD.
