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.

up to $6.7M
award range
Closed
application status
93.853;93.866
CFDA program

Opportunity snapshot. This Grants.gov announcement - 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 cataloged under number RFA-NS-25-010 and tied to CFDA assistance listing 93.853;93.866, posted by National Institutes of Health. Grants.gov currently shows the opportunity as closed, first posted on May 21, 2024 and last updated on May 23, 2024. The funding category is Discretionary, delivered as a cooperative agreement.

Award economics. The award range on file is Up to $6,700,000. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.

Deadline and action path. This opportunity closed on January 24, 2025. Future funding cycles may be published under the same CFDA number, so monitoring the parent program page is the most reliable way to catch re-announcements. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.

Award Range

Up to $6,700,000

Close Date

January 24, 2025

Posted

May 21, 2024

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.

Eligibility

Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.

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

Key Dates

Posted May 21, 2024
Close Date January 24, 2025
Archive Date March 1, 2025
Last Updated May 23, 2024

Frequently Asked Questions

What is this grant opportunity?
This is a federal funding opportunity titled "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)", offered by National Institutes of Health. It is associated with CFDA program 93.853;93.866. 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 t...
Is this opportunity still open?
No, this opportunity is closed. It closed on January 24, 2025. Check the parent program page for future funding cycles.
How much funding is available?
The award range for this opportunity is Up to $6,700,000.
How do I apply?
Applications for federal grant opportunities are typically submitted through Grants.gov. Visit the official listing at grants.gov for application instructions, required documents, and submission deadlines.

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