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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)

Posted
May 21, 2024
Closed
January 24, 2025
Award ceiling
$6,700,000
Cost sharing
No
Instrument
Cooperative Agreement
Assistance listing
93.853, 93.866
Category
Health
Archives
March 1, 2025

Program funding history

Awards made under Assistance Listing 93.853 (one of 2 on this opportunity) across FY2025–FY2027, from public federal spending records.

FY2025 obligated
$1.8B
FY2026 obligated
$2B
FY2027 (to date) obligated
$0
Awards in window
8,124

Top recipients: The General Hospital Corporation, Regents of the University of California, San Francisco, the, The Johns Hopkins University, Regents of the University of Michigan, Washington University, the

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

This opportunity is archived. Applications are no longer accepted. Similar grants are listed below, and the free Tuesday digest carries the next ones like it.

Synopsis

This RFA is soliciting applications proposing placebo-controlled, clinical trials to determine the efficacy and safety of FDA approved monoclonal antibody therapies directed against amyloid compared to placebo in diverse "mixed dementia" populations with a focus on Lewy Body Dementias (LBD). In this NOFO the mixed-etiology dementias (MED) that are of interest and that are in scope are cognitive impairment and dementia cases positive for 1) canonical Alzheimers pathology biomarkers (for example, amyloid deposition assessed using positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) a clinical LBD diagnosis, i.e. Parkinsons disease dementia (PDD) and/or dementia with Lewy bodies (DLB). Bayesian approaches with response adaptive randomization to examine specific subgroups are encouraged. Successful applications will be powered to determine efficacy in diverse populations representative of the distribution of the disease in the United States by sex, race/ethnicity, and geographic distribution. Applications must include elements of patient and community engagement that are incorporated into all stages of program development and at all levels of the organizational structure.

Who can apply

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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

The official record

Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.

View on Grants.gov   Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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