Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)

The National Institutes of Health (NIH) is providing funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease, slow its progression, or treat its cognitive and behavioral symptoms. The goal of this Notice of Funding Opportunity (NOFO) is to support therapy development activities such as medicinal chemistry, pharmacokinetics, Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET), efficacy in animal models, development of biomarkers for target engagement, formulation development, chemical synthesis under Good Manufacturing Practices (GMP), Investigational New Drug (IND) enabling studies, and initial Phase I clinical testing. • The funding will support pre-clinical and early stage clinical development of novel drug candidates. • The goal is to prevent Alzheimer's disease, slow its progression, or treat its cognitive and behavioral symptoms. • The funding will support therapy development activities such as medicinal chemistry, pharmacokinetics, and formulation development. • The funding will also support initial Phase I clinical testing. • Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action, development of risk, diagnostic, prognostic, predictive, and prevention biomarkers, devices, non-pharmacological interventions, repurposed drugs and combination therapies, discovery activities, and stand-alone clinical trials.