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.
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.
All applications are due by 5:00 PM local time of the applicant organization.
Eligible applicants include:
Note: Applicant organizations must complete all required registrations (SAM, eRA Commons, Grants.gov, etc.) before applying.
Contact Type | Name/Email | Phone |
---|---|---|
Scientific/Research Contact | Akanni Clarke, Ph.D. akanni.clarke@nih.gov | 301-496-9350 |
Scientific/Research Contact | Laurie Ryan ryanl@mail.nih.gov | 301-496-9350 |
Peer Review Contact | Ramesh Vemuri ramesh.vemuri@nih.gov | 301-402-7700 |
Grants Management Contact | Philip Smith philip.smith2@nih.gov | 301-402-3465 |
General Grants Info | GrantsInfo@nih.gov | 301-480-7075 |
eRA Service Desk | eRA Service Desk | 301-402-7469 or 866-504-9552 |