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: 357343Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357343

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-226.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "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)." This initiative aims to streamline the early-stage evaluation of promising pharmacological interventions by bundling independent protocols for phase 1 clinical trials with phase 1b/phase 2a trials, focusing on non-amyloid/non-tau mechanisms that address cognitive and neuropsychiatric symptoms across various stages of the disease. The program is particularly significant given the rising prevalence of Alzheimer's and the associated economic burden, emphasizing the need for innovative treatments as the aging population grows. Eligible applicants include a diverse range of organizations, such as higher education institutions and community-based organizations, with proposals due by November 19, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-25-226.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-226-Full-Announcement.html
    PAR-25-226.html
    The Department of Health and Human Services, through the National Institute on Aging (NIA), has issued a funding opportunity titled "Seamless Early-Stage Clinical Drug Development for Novel Therapeutic Agents for Alzheimer's Disease (AD) and AD-related Dementias (ADRD)." This initiative seeks to streamline early-stage clinical trials by combining phase 1 with phase 1b/phase 2a trials for promising pharmacological interventions that focus on non-amyloid/non-tau mechanisms addressing cognitive or neuropsychiatric symptoms in individuals at various disease stages. The application must detail prespecified safety and tolerability milestones to progress through clinical phases. Key eligibility includes a range of organizations, including higher education institutions and nonprofits, with a project duration of up to five years. The initiative aims to accelerate the development of new treatments against Alzheimer’s, reflecting a critical need as the aging population rises, and the economic burden of AD/ADRD escalates. Eligible applicants are encouraged to enhance diversity in research, with an emphasis on robust data management and sharing practices. The proposal outlines a cooperative agreement format, emphasizing substantial federal involvement in managing and monitoring projects through defined guidelines and milestones. Overall, this funding opportunity highlights the federal government's commitment to advancing Alzheimer's research and therapeutic innovations.
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