Grant opportunity · PAR-25-226
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)
Who can apply (as listed)
- County governments
- City or township governments
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
- For-profit organizations (other than small businesses)
- Others (see the opportunity text)
- Native American tribal governments (federally recognized)
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- Public housing authorities / Indian housing authorities
- State governments
- Native American tribal organizations (other than federally recognized governments)
- Private institutions of higher education
- Small businesses
- Public and state-controlled institutions of higher education
- Special district governments
- Independent school districts
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.
Excerpt as published. The full synopsis, required forms, and any amendments are on the official listing.
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