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)
Funding
Not specified
Deadline
--
Days
--
Hrs
--
Min
--
Sec
Nov 19, 2026
Posted Nov 22, 2024 (455 days ago)
Closes Nov 19, 2026 (in 271 days)
Grant Details
Opportunity Number
PAR-25-226
CFDA / ALN
93.242
Opportunity Category
Discretionary (D)
Funding Category
Health (HL)
Funding Instrument
Cooperative Agreement (CA)
Cost Sharing
No Cost Sharing (No)
Eligibility
State governments (00)
County governments (01)
City or township governments (02)
Special district governments (04)
Independent school districts (05)
Public and State controlled institutions of higher education (06)
Native American tribal governments (Federally recognized) (07)
Public housing authorities / Indian housing authorities (08)
Native American tribal organizations (11)
Nonprofits having a 501(c)(3) status with the IRS (12)
Nonprofits without 501(c)(3) status (13)
Private institutions of higher education (20)
For-profit organizations other than small businesses (22)
Small businesses (23)
Others (25)
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.
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.
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