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

The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose pre-clinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that aim to prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms.

Through the NOFO, NIA is continuing the Alzheimer's Drug-Development Program (ADDP) with the aim of catalyzing drug development for AD. The ADDP is designed to provide funding support to academic and biotech researchers for preclinical drug development activities that can be conducted in their own laboratories or conducted in collaboration with contract research organizations that specialize in preclinical drug development activities. By supporting the most challenging and costly steps of drug development and seamlessly connecting preclinical drug development and first-in-human testing for drug candidates, the ADDP program seeks to:

Continue to expand the number of investigational new drug candidates for a portfolio of emerging therapeutic targets; Continue to expand the therapeutic pipeline for AD with drug candidates targeting multiple underlying disease mechanisms that can be used as mono-therapy or as part of combination therapy; and Enable a precision medicine approach to AD drug development. The NOFO will utilize the U01 activity code. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.