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)

The purpose of this Notice of Funding Opportunity (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 Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. 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 latter stages of clinical development.

This opportunity from National Institutes of Health is open to eligible applicants nationwide. Organizations working in Healthcare are especially encouraged to review the requirements.

Federal grant opportunities like this one are typically open to a range of applicant types. Common eligible organizations include:

• Nonprofits and 501(c)(3) organizations
• Small businesses and startups (especially for SBIR/STTR programs)
• State, local, and tribal governments
• Colleges, universities, and research institutions
• Individuals (for select programs in education, arts, and research)

Eligibility requirements vary by opportunity. Always review the official listing before investing time in an application.