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)
NIH will support UG3/UH3 cooperative agreement clinical trials that run early-stage phase 1 to phase 1b/2a drug development for novel non-amyloid/non-tau therapeutics for Alzheimer’s disease and Alzheimer’s disease-related dementias, with milestones gating progression from safety/tolerability into later testing.
⚑ Clinical trial required · UG3/UH3 phased mechanism with prespecified go/no-go milestones · Non-amyloid/non-tau mechanisms only · Interventions must target cognitive and/or neuropsychiatric symptoms in AD/ADRD
Unit fits — one characterization, each unit's own rules
| IPPRA | 35 weak | peripheral portfolio topic: public_health; social/behavioral work is minor; funds other — not a research fit; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped) |
| Physical Sciences & Engineering (demo) | 25 weak | technical depth: minor; funds other (capped) |
| Tom Love Innovation Hub | 15 none | deep-tech content; no commercialization signal |
Description
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.
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
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