The Alzheimer's Drug Development Program, managed by the National Institute on Aging under the NIH, invites applications for the preclinical and early-stage clinical development of novel drug candidates targeting Alzheimer’s disease. This Notice of Funding Opportunity is designated for cooperative agreements under activity code U01. Projects may involve small molecules, biologics, or other innovative agents aimed at preventing Alzheimer’s disease, slowing its progression, or treating its cognitive and behavioral symptoms. The program emphasizes developing candidates for FDA approval and supports both Early and Late Stage drug development.

Funding is limited to $1.5 million in direct costs per year, with project periods of up to five years for Early Stage projects and four years for Late Stage projects. The number of awards depends on available appropriations and the merit of submitted applications. Key dates include an open submission start on January 3, 2025, with standard NIH due dates applying, beginning with February 5, 2025.

The program supports medicinal chemistry, pharmacokinetics, toxicology studies, efficacy testing in animal models, biomarker development, formulation under Good Manufacturing Practices, IND-enabling studies, and Phase I clinical trials. Early Stage projects focus on optimizing drug-like properties and conducting dose-range toxicology, while Late Stage projects advance candidates through IND-enabling studies and initial clinical trials.

Eligible applicants include higher education institutions, nonprofits, for-profits, government entities, and tribal organizations. Foreign institutions are not eligible, though foreign components of U.S. organizations may participate. Applicants must complete registrations with SAM.gov, eRA Commons, and Grants.gov.

Applications should include specific aims for either Early or Late Stage projects, a Target Product Profile summarizing the drug’s clinical goals, a research strategy detailing clinical impact, biological rationale, testing strategies, milestones, and intellectual property considerations, and a data management and sharing plan to ensure compliance with NIH policies. Milestone-driven objectives must be defined to monitor progress and enable go/no-go decision-making.

Applications will be evaluated based on significance and innovation, rigor and feasibility, and the expertise of investigators and resources of the institution. Additional considerations include protections for human subjects, vertebrate animal use, budget justification, and alignment with NIH priorities for the inclusion of underrepresented populations.

Projects focused on anti-amyloid therapies, generic drugs, repurposed compounds, diagnostics, or beyond Phase I trials are deemed non-responsive. Awardees must comply with NIH data and safety monitoring requirements, Good Laboratory Practices, and Good Clinical Practices for clinical trials. Applications must be submitted through Grants.gov or NIH’s ASSIST system. Early contact with program officers is encouraged to ensure project alignment. Notifications of award decisions will be provided through the NIH eRA Commons. For further information, applicants can contact the scientific or financial contacts listed in the Notice of Funding Opportunity. This funding opportunity aligns with NIA’s strategic goals to advance therapeutic development for Alzheimer’s disease and related dementias.