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: November 19, 2026 (Resubmission / Revision; final deadline)
Funding Amounts: No budget cap; UG3 up to 2 years, combined UG3/UH3 up to 5 years
Summary: Supports bundled phase 1 through phase 2a clinical trials of non-amyloid/non-tau therapeutics for Alzheimer’s disease and related dementias.
Key Information: Applications must include both UG3 and UH3 activities, with prespecified safety and tolerability milestones governing progression.
Description
The National Institute on Aging (NIA), part of NIH, supports early-stage clinical development of promising pharmacological interventions for Alzheimer’s disease (AD) and AD-related dementias (ADRD). This cooperative agreement bundles independent phase 1 and phase 1b/phase 2a protocols into one application to accelerate successive evaluation. Candidates may include novel small molecules, biologics, or repurposed drugs addressing cognitive and/or neuropsychiatric symptoms from pre-symptomatic through more severe disease stages.
Supported work includes safety, tolerability, pharmacokinetics, dosing, food-effect studies, biomarker analysis, target engagement, and human proof-of-concept studies. Drug manufacturing and regulatory preparation needed for the trials may also be supported. UG3 funds phase 1 planning and execution; UH3 primarily supports phase 2a trials. The program is not intended for definitive efficacy trials.
