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)

The summary for the 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) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

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): 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.

Federal Grant Title:	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 Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-NS-25-010
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.853, 93.866
CFDA Descriptions:	Information not provided
Current Application Deadline:	January 24th, 2025
Original Application Deadline:	January 24th, 2025
Posted Date:	May 21st, 2024
Creation Date:	May 21st, 2024
Archive Date:	March 1st, 2025
Total Program Funding:
Maximum Federal Grant Award:	$6,700,000
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:	No
Last Updated:	May 21st, 2024

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility: 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.
Link to Full Grant Announcement: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-010.html
Grant Announcement Contact: NIH Grants Information
[email protected]
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
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