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)

HHS-NIH11 PAR-25-226

Posted: Nov 22, 2024 12:00:00 AM EST

Closes: 11/19/2026

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.

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.

Eligibility

Eligible Applicants:

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

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.

Funding Activity Categories

Health

CFDA Numbers

93.242 - Mental Health Research Grants

Contact Information

Agency: National Institutes of Health

Contact: National Institutes of Health

Email: grantsinfo@nih.gov

Phone: 301-402-2541

NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis

Opportunity Category: Discretionary

Version: 1

Last Updated: Nov 22, 2024 02:08:28 PM EST

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