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)
National Institutes of Health (NIH)
Total budget is not limited but must reflect the actual needs of the proposed project.
UG3 phase must not exceed 2 years; total duration of UG3/UH3 phases combined must not exceed 5 years.
To streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease and related dementias.
Encourages biomedical, social, and behavioral research directed toward understanding the aging process and related diseases.
Researchers and institutions involved in Alzheimer's disease research.
Individuals affected by Alzheimer's disease and related dementias.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local, state, and federal governments, and foreign organizations.
Specific qualifications include having an eRA Commons account for Program Directors/Principal Investigators.
Eligible organizations can be based in the U.S. or be foreign entities.
Non-domestic components of U.S. organizations are also eligible.
Applications must bundle independent protocols for phase 1 and phase 1b/phase 2a clinical trials.
Focus on non-amyloid/non-tau mechanisms addressing cognitive and neuropsychiatric symptoms.
Application budgets are not limited but must reflect the actual needs of the proposed project.
No cost-sharing is required.
Application due date is November 19, 2026.
Earliest submission date is January 21, 2025.
Applicant organizations may submit more than one application, provided each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications under review at the same time.
Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
Include prespecified, go/no-go safety and tolerability milestones.
Applications will be evaluated for scientific and technical merit using established NIH peer review criteria.
Applications will undergo a two-level review process, including scientific peer review and advisory council review.
Scientific and technical merit, availability of funds, and relevance to program priorities will be considered.
Substantial federal involvement is anticipated in the project activities.
Applications proposing definitive efficacy trials (e.g., Phase 3 trials) will be considered nonresponsive.
Encouragement to consult with NIA Program staff at least 12 weeks prior to submission.
Timely access to trial data and associated biosamples to the broader research community is required.
Clear go/no-go criteria for proceeding with subsequent clinical trials.
Non-compliance with application instructions may lead to delays or non-acceptance.
Engage with NIH staff early in the application process for guidance.
Highlight the innovative aspects of the proposed research and its relevance to current challenges in AD treatment.