PAR-25-226-Full-Announcement.html

This document is a Notice of Funding Opportunity (NOFO) for the Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required) grant opportunity.

The purpose of this NOFO is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for AD and ADRD. Eligible applicants include higher education institutions, for-profit organizations, non-profits, local governments, and tribal organizations. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to later stages of clinical development. The grant opportunity is funded by the National Institute of Mental Health under the Mental Health Research Grants program (CFDA 93.242).