Closed · RFA-NS-25-010 · CFDA 93.853;93.866 · Discretionary

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)

Federal grant opportunity posted by National Institutes of Health, cataloged on Grants.gov.

up to $6.7M
Award range
Closed
Status
January 24, 2025
Close date
-
Expected awards

The verdict

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) is a closed discretionary listing from National Institutes of Health that offered Up to $6,700,000. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 12,419 other opportunities from National Institutes of Health.

up to $6.7M
award range
Closed
application status
93.853;93.866
CFDA program
12,419
other opportunities from National Institutes of Health

Archived opportunity record

Safety and Efficacy of Amyloid-Beta Directed… is closed (last close January 24, 2025). Check the agency catalog for replacement NOFOs. National Institutes of Health still indexes 12,419 other opportunities here.

According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.

Deadline tracker

Application window closed

Closed January 24, 2025

Posted May 21 Closes Jan 24

Instrument

Cooperative Agreement

Description

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.

Wide-open applicant board · 15 Grants.gov doors

Safety and Efficacy of Amyloid-Beta Directed… prints 15 distinct Grants.gov eligibility doors (State governments; County governments; City or township governments; Special district governments; +11 more). Filter fit before reading award size as demand — most applicant classes appear on the row. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity code maps to Health (HL). This eligibility-code string dominates the National Institutes of Health book (9,741 peers, 78% of 12,420).

Code 00
State governments
Code 01
County governments
Code 02
City or township governments
Code 04
Special district governments
Code 05
Independent school districts
Code 06
Public / state-controlled institutions of higher education
Code 07
Federally recognized tribal governments
Code 08
Public / Indian housing authorities
Code 11
Native American tribal organizations (other than Federally recognized tribal governments)
Code 12
Nonprofits with 501(c)(3) status (other than IHEs)
Code 13
Nonprofits without 501(c)(3) status (other than IHEs)
Code 20
Private institutions of higher education
Code 22
For-profit organizations other than small businesses
Code 23
Small businesses
Code 25
Others (see official listing text)

Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.

Official Listing on Grants.gov

View full details, application forms, and submission instructions.

View on Grants.gov

Agency Contact

NIH Grants Information grantsinfo@nih.gov

What to do next

Safety and Efficacy of Amyloid-Beta Directed… is closed; use the parent program and agency catalog for the next funding cycle.

  • Browse open federal opportunities in the same category when this listing is closed. Open opportunities
  • Look up CFDA 93.853;93.866 across all indexed listings before you commit to this opportunity alone. Eligibility finder
  • National Institutes of Health lists 12,419 other indexed opportunities on PlainGrants. Agency catalog

Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.

Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.

Data sourced from the SAM.gov Assistance Listings and Grants.gov. See our methodology for details. Retrieved and formatted by PlainGrants