Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
Funding for Alzheimer's drug development from pre-clinical to Phase I clinical trials to prevent, slow, or treat AD symptoms, excluding basic research and non-pharmacological interventions.
Funder: National Institutes of Health
Due Dates: June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | February 5, 2026 (New) | March 5, 2026 (Renewal/Resubmission/Revision) | June 5, 2026 (New) | July 5, 2026 (Renewal/Resubmission/Revision) | October 5, 2026 (New) | November 5, 2026 (Renewal/Resubmission/Revision) | February 5, 2027 (New) | March 5, 2027 (Renewal/Resubmission/Revision) | June 5, 2027 (New) | July 5, 2027 (Renewal/Resubmission/Revision) | October 5, 2027 (New) | November 5, 2027 (Renewal/Resubmission/Revision)
Funding Amounts: Up to $1,500,000 direct costs/year; up to 5 years (Early Stage) or 4 years (Late Stage) per project.
Summary: Supports pre-clinical and Phase I clinical development of novel small-molecule and biologic drug candidates to prevent, slow, or treat Alzheimer's disease, excluding basic research and non-pharmacological interventions.
Key Information: Applications focused on anti-amyloid, anti-tau, repurposed drugs, combination therapies, or stand-alone clinical trials are not eligible.
Description
This opportunity provides funding for the pre-clinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates targeting Alzheimer's disease (AD). The program aims to catalyze the development of therapies that prevent AD, slow its progression, or treat its cognitive and behavioral symptoms. Supported activities include medicinal chemistry, pharmacokinetics (PK), ADMET, efficacy studies in animal models, biomarker development for target engagement, formulation development, GMP chemical synthesis, IND-enabling studies, and initial Phase I clinical testing.
Projects may enter at either an early stage (optimization and IND-enabling studies) or late stage (IND-enabling studies through Phase I clinical testing). The program is milestone-driven and requires clear go/no-go criteria for each year of funding.
Note: Applications focused on basic mechanisms of disease, mechanisms of drug action, anti-amyloid or anti-tau therapies, repurposed drugs, combination therapies, diagnostics, or stand-alone clinical trials are not eligible.
