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Efficacy and Safety of Amyloid-Beta Directed Antibody Therapy in Mild Cognitive Impairment and Dementia with Evidence of Both Amyloid-Beta and Vascular Pathology (U01 - Clinical Trial Required)
This RFA will solicit applications for a pivotal phase 3 clinical trial to determine the efficacy of FDA approved monoclonal antibody therapy compared to placebo in diverse "mixed dementia" populations with a focus on vascular contributions.
Mixed dementia refers to dementia cases positive for 1) Alzheimer biomarkers, such as amyloid positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) evidence of vascular contributions based on imaging (white matter disease and/or subclinical infarction).
Bayesian approaches with response adaptive randomization to examine specific subgroups are engouraged.
Successful applications will be well-powered to determine efficacy in diverse populations representative of the effect of the disease in the United States by sex, race/ethnicity, and geographic distribution.
Applications must include patient and community engagement cores that are incorporated into all stages of program development and at all levels of the organizational structure.
Mixed dementia refers to dementia cases positive for 1) Alzheimer biomarkers, such as amyloid positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) evidence of vascular contributions based on imaging (white matter disease and/or subclinical infarction).
Bayesian approaches with response adaptive randomization to examine specific subgroups are engouraged.
Successful applications will be well-powered to determine efficacy in diverse populations representative of the effect of the disease in the United States by sex, race/ethnicity, and geographic distribution.
Applications must include patient and community engagement cores that are incorporated into all stages of program development and at all levels of the organizational structure.
Related Programs
Department of Health and Human Services
Extramural Research Programs in the Neurosciences and Neurological Disorders
Department of Health and Human ServicesDepartment of Health and Human Services
Agency: Department of Health and Human Services
Office: National Institutes of Health
Estimated Funding: $0
Office: National Institutes of Health
Estimated Funding: $0
Who's Eligible
Relevant Nonprofit Program Categories
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-013.html
Additional Information of 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 Institutions) 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 not allowed.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-013.html
Contact:
Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Agency Email:
Date Posted:
2023-10-19
Application Due Date:
Archive Date:
2024-03-27
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