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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)

ID: PAR-25-226 • Type: Posted

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.
Background
The National Institutes of Health (NIH), specifically the National Institute on Aging (NIA), is issuing this Notice of Funding Opportunity (NOFO) to address the urgent need for effective interventions against Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD).

With over 6 million Americans aged 65 and older currently living with AD, and projections suggesting this number could rise to 12.7 million by 2050, the economic burden of AD/ADRD is estimated to exceed $355 billion.

The goal of this NOFO is to streamline early-stage clinical trials for promising pharmacological interventions that engage non-amyloid/non-tau mechanisms, targeting cognitive and neuropsychiatric symptoms across various stages of the disease. This initiative aligns with the National Alzheimer's Project Act's objective to prevent and effectively treat AD/ADRD by 2025.

Grant Details
This NOFO invites applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials. The proposed activities include:
- Evaluation of safety and pharmacokinetics of novel therapeutics in healthy volunteers or target populations.
- Projects directed at a phase I trial referencing prior Good Laboratory Practice (GLP) toxicology studies.
- Good manufacturing practice (GMP) for drug substance/product needed for clinical trials.
- Preparation of protocols and acquisition of regulatory approvals.
- Food effect studies.
- Evaluation and optimization of dose, formulation, safety, tolerability, or pharmacokinetics to enable FDA-required activities for starting phase 2a.
- Acquisition and analysis of biomarkers.
- Evaluation of intervention efficacy through human proof-of-concept trials.

Applications must include prespecified go/no-go safety and tolerability milestones that must be met to advance from phase 1 to later stages of clinical development.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations (including small businesses), local governments, state governments, tribal governments, federal agencies, foreign organizations, and other entities such as public housing authorities. Individuals from diverse backgrounds are encouraged to apply.

Period of Performance
The UG3 phase must not exceed 2 years, while the total duration for both UG3/UH3 phases combined must not exceed 5 years.

Grant Value
Application budgets are not limited but must reflect the actual needs of the proposed project. The number of awards will depend on NIH appropriations and the submission of meritorious applications.

Overview

Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 11/22/24 the National Institutes of Health posted grant opportunity PAR-25-226 for 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). The grant will be issued under grant program 93.242 Mental Health Research Grants.

Timing

Posted Date
Nov. 22, 2024, 12:00 a.m. EST
Closing Date
Nov. 19, 2026, 12:00 a.m. EST Due in 710 Days
Last Updated
Nov. 22, 2024, 2:08 p.m. EST
Version
1
Archive Date
Dec. 25, 2026

Eligibility

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

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-226.html

Documents

Posted documents for PAR-25-226

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