RFA-NS-25-010: 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)
Closed
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2024.
National Institutes of Health offered grants of up to $6.7 million to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on January 24, 2025.
From the official notice on Grants.gov, last changed May 21, 2024. Checked November 7, 2026.
- Award ceiling$6.7 million
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeU01
- Clinical trialsRequired
- Funded byNINDS
- Median yearly award$4.2 million
- Typical project length7 years
- U01, Research Project Cooperative Agreement. Like an R01, but NIH staff are substantially involved in the work. Other open U01 notices.
Projects funded under RFA-NS-25-010 were run by National Institute of Neurological Disorders and Stroke (NINDS, 1 project). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read RFA-NS-25-010 in the NIH Guide.
Key dates
| Posted | May 21, 2024 |
|---|---|
| Deadline | January 24, 2025 |
| Archived by Grants.gov | March 1, 2025 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- 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)
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.
Is this a realistic fit?
- Projects NIH funded under this notice had a median yearly award of $4.2 million; it allows up to $6.7 million per award.
- Most of the money in the 2 programs behind this notice (74% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
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.
Funded under RFA-NS-25-010 so far
NIH funded 1 project under RFA-NS-25-010 in fiscal 2026, at 1 institution. The median yearly award was $4.2 million.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| Amyloid clearing therapy in dementia with Lewy bodies plus Alzheimers disease (ACT DLB+) | Stanford University | 2026 | $4.2 million |
Who has won Aging Research grants before
From fiscal 2021 to 2025, Aging Research (93.866) awarded $19 billion across 11,026 grant awards, an average of $1.7 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Regents of the University of California, San Francisco | California | 337 | $575 million |
| The Trustees of Columbia University in the City of New York | New York | 242 | $574 million |
| University of Southern California | California | 203 | $572 million |
| The Washington University | Missouri | 210 | $556 million |
| Regents of the University of Michigan | Michigan | 232 | $538 million |
Who has won Extramural Research Programs in the Neurosciences and Neurological Disorders grants before
From fiscal 2021 to 2025, Extramural Research Programs in the Neurosciences and Neurological Disorders (93.853) awarded $9.1 billion across 8,641 grant awards, an average of $1.0 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The General Hospital Corporation | Massachusetts | 203 | $288 million |
| The Regents of the University of California, San Francisco | California | 248 | $277 million |
| The Johns Hopkins University | Maryland | 230 | $276 million |
| The Trustees of Columbia University in the City of New York | New York | 188 | $226 million |
| Regents of the University of Michigan | Michigan | 179 | $221 million |
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-NS-25-010 still open?
No. It closed on January 24, 2025.
Who can apply for 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)?
National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for 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)?
Closed January 24, 2025. Applications are no longer accepted; the program's newer notices are on this page when there are any.
How much funding is available?
Awards of up to $6.7 million each.
Who has been funded under RFA-NS-25-010?
NIH RePORTER lists 1 project funded under RFA-NS-25-010 in fiscal 2026, at 1 institution.
Who has won Extramural Research Programs in the Neurosciences and Neurological Disorders grants before?
The largest recipients over five fiscal years were The General Hospital Corporation, The Regents of the University of California, San Francisco, The Johns Hopkins University. The program made 8,641 awards worth $9.1 billion in that time.
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