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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)

National Institutes of Health

PAR-25-226

HHS-NIH11

General Information

Est. Program Funding:

November 19, 2026

Closing Date:

Expected No. of Awards

Award Ceiling

Opportunity Number:
PAR-25-226

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

Synopsis

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.

Response Date	Nov 19, 2026 12:00:00 AM EST
Posting Date	Nov 22, 2024 12:00:00 AM EST
Archive Date	Dec 25, 2026 12:00:00 AM EST
Award Ceiling
Award Floor
Cost Sharing	No

Eligibility

Eligible Applicants

Others (see text field entitled "Additional Information on Eligibility" for clarification), Private institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Independent school districts, Small businesses, City or township governments, State governments, County governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses, Native American tribal governments (Federally recognized), Special district governments, Public and State controlled institutions of higher education, Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments)

Additional Info on 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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	https://grants.nih.gov/grants/guide/pa-files/PAR-25-226.html
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

93.242: Mental Health Research Grants
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