Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
National Institutes of Health (NIH)
Maximum grant amount: $1,500,000 per year
Project duration: Early Stage projects limited to five years; Late Stage projects limited to four years.
To provide funding support for the pre-clinical and early stage clinical development of novel drug candidates that prevent Alzheimer's disease, slow its progression, or treat its cognitive and behavioral symptoms.
Researchers in the field of Alzheimer's disease.
Patients affected by Alzheimer's disease.
Eligible organization types include higher education institutions, nonprofits, small businesses, local governments, state governments, and tribal governments.
Non-domestic (non-U.S.) entities are not eligible to apply, but non-domestic components of U.S. organizations are allowed.
Organizations must be based in the U.S. or have U.S. components.
Projects must focus on the development of drug candidates for Alzheimer's disease.
Applications must propose pre-clinical or early stage clinical development activities.
Application budgets are limited to $1,500,000 in direct costs per year.
Application deadlines are set for various dates, with the next due date being June 5, 2025.
All applications are due by 5:00 PM local time of the applicant organization.
The NIH will not accept duplicate or highly overlapping applications under review at the same time.
Applicants must follow the instructions in the Research Instructions in the How to Apply - Application Guide.
Applications will be evaluated based on significance, innovation, approach, investigator(s), and environment.
Applications will undergo peer review and will be evaluated for scientific and technical merit.
Applications that demonstrate a strong scientific rationale and innovative approaches will be prioritized.
Projects must adhere to NIH guidance on rigor and reproducibility.
High competition for funding due to the popularity of Alzheimer's research.
Collaboration with contract research organizations (CROs) is encouraged.
Strong preliminary data and innovative approaches may provide a competitive edge.
Demonstrating a clear pathway to FDA approval for drug candidates.
Submitting applications that do not comply with the application instructions.
Engage with NIH program staff early to discuss project suitability.
Highlight unique aspects of the proposed drug candidates and their potential impact on Alzheimer's treatment.