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 for the development of novel small-molecule and biologic drug candidates that aim to prevent Alzheimer's disease, slow its progression, or treat its cognitive and behavioral symptoms. The NOFO will utilize the U01 activity code and will provide funding support to academic and biotech researchers for preclinical drug development activities. The goal of the program is to catalyze drug development for Alzheimer's disease 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. Key aspects of the opportunity include: • The development of novel small-molecule and biologic drug candidates for Alzheimer's disease • The provision of funding support to academic and biotech researchers for preclinical drug development activities • The goal of catalyzing drug development for Alzheimer's disease by supporting the most challenging and costly steps of drug development • The connection of preclinical drug development and first-in-human testing for drug candidates • The utilization of the U01 activity code for the NOFO