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)

This Notice of Funding Opportunity (NOFO) is inviting submissions for a grant aimed at aiding the early-stage clinical trails of new treatments for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). The intention of the grant is to expedite these trials by bundling together independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials.

The proposed interventions for evaluation should focus on mechanisms other than amyloid and tau, the common features of AD, and aim to alleviate the cognitive and neuropsychiatric symptoms of AD and ADRD. These should be applicable to individuals at various stages of the condition, from pre-symptomatic to severe. The interventions can include different types of therapeutic agents such as small molecules or biologics.

The grant is structured using the UG3/UH3 phased award mechanism. Applications must therefore document pre-determined safety and tolerability checks. These checks will determine whether projects progress from the first phase of clinical development to later stages.