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    Clear

    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 Re

    RFA-NS-25-010

    National Institutes of Health

    Opening date 21 May 2024, 12:00AM

    Closing date 24 Jan 2025, 12:00AM

    Funding Opportunity Number: RFA-NS-25-010

    Opportunity Category: Discretionary

    CFDA Number(s): 93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders,93.866 -- Aging Research

    Cost Sharing or Matching Requirement: No

    Posted Date: May 21, 2024 12:00:00 AM EDT

    Closing Date: Jan 24, 2025 12:00:00 AM EST

    Award Ceiling: $6700000

    Award Floor: none

    Eligible Applicants: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,Native American tribal governments (Federally recognized),Private institutions of higher education,For profit organizations other than small businesses,State governments,Independent school districts,Small businesses,Public and State controlled institutions of higher education,Special district governments,Public housing authorities/Indian housing authorities,Native American tribal organizations (other than Federally recognized tribal governments),Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education,Others (see text field entitled "Additional Information on Eligibility" for clarification),City or township governments,County governments

    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.

    Agency Name: National Institutes of Health

    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.

    Grantor Contact Information: NIH Grants Information grantsinfo@nih.gov

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