Safety and Efficacy of Amyloid-Beta Directed Antibody Therapy in Mild Cognitive Impairment and Dementia with Evidence of Lewy Body Dementia and Amyloid-Beta Pathology (U01 - Clinical Trial Required)
ID: 354378Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $7M

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/354378

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-010.html
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for a federal grant aimed at conducting Phase 2 clinical trials to evaluate the safety and efficacy of monoclonal antibody therapies targeting amyloid-beta in populations with mixed-etiology dementia, particularly focusing on Lewy Body Dementias (LBD). The initiative seeks randomized placebo-controlled trials involving participants who exhibit Alzheimer's pathology and have a clinical diagnosis of LBD, such as Parkinson's disease dementia or dementia with Lewy bodies, while emphasizing community engagement to ensure diverse representation and enhance participant retention. This funding opportunity, with an award ceiling of $6.7 million, is part of the National Alzheimer’s Project Act's objectives to advance treatments for Alzheimer’s Disease and related dementias, with applications due by January 25, 2025. Interested applicants can find more information and submit their proposals through Grants.gov, and may contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-NS-25-010-Full-Announcement.html
    RFA-NS-25-010.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), seeks applications for Phase 2 clinical trials evaluating the safety and efficacy of monoclonal antibody therapies targeting amyloid-beta in mixed-etiology dementia populations, specifically focusing on Lewy Body Dementias (LBD). This funding opportunity (RFA-NS-25-010) encourages randomized placebo-controlled trials involving participants with evidence of Alzheimer's pathology and a clinical diagnosis of LBD, such as Parkinson's disease dementia or dementia with Lewy bodies. The initiative emphasizes community engagement throughout the research process to include diverse populations and enhance participant retention, particularly addressing health disparities. Applications are due by January 25, 2025, requiring submissions through Grants.gov, with a projected budget of $10 million for one award. Applicants must adhere to rigorous scientific standards and include detailed plans for team management and community engagement. The research aims to generate insights into the risks and benefits of amyloid immunotherapies, addressing current gaps in knowledge regarding their efficacy in individuals presenting with mixed dementia symptoms. Overall, this funding opportunity aligns with the National Alzheimer’s Project Act’s objectives to advance treatments for Alzheimer’s Disease and related dementias.
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