At a glance
This program funds early-stage clinical trials of novel non-amyloid, non-tau drugs or biologics for Alzheimer’s disease and related dementias, including phase 1, phase 1b, food effect, and phase 2a studies. It is for applications that bundle phase 1 work with later phase 1b/2a work, and the award uses a UG3/UH3 phased cooperative agreement. Eligible applicants include nonprofits, universities, governments, for-profits, small businesses, faith-based and community groups, and foreign organizations; foreign components of U.S. organizations are also allowed. The number of awards is contingent on NIH appropriations and meritorious applications, budgets are not limited but must fit the project, and cost sharing is not required. The UG3 phase may not exceed 2 years, and the combined UG3/UH3 project period may not exceed 5 years.
What it funds
Official description from grants.gov
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.
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments