This grant is for conducting placebo-controlled clinical trials to determine the efficacy and safety of FDA-approved monoclonal antibody therapies targeting amyloid. The focus is on diverse “mixed dementia” populations, specifically individuals with Lewy Body Dementias (LBD) exhibiting canonical Alzheimer’s pathology biomarkers (e.g., amyloid deposition, elevated phosphorylated tau) and a clinical LBD diagnosis (Parkinson’s disease dementia or dementia with Lewy bodies). Applicants are encouraged to use Bayesian approaches with response-adaptive randomization. Studies must be powered to show efficacy in diverse U.S. populations, representative of sex, race/ethnicity, and geography. Integral patient and community engagement throughout all program stages is required.
Opportunity ID: 354378
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-25-010 |
| Funding Opportunity 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) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 21, 2024 |
| Last Updated Date: | May 21, 2024 |
| Original Closing Date for Applications: | Jan 24, 2025 |
| Current Closing Date for Applications: | Jan 24, 2025 |
| Archive Date: | Mar 01, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,700,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Independent school districts City or township governments Special district governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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. |
Additional Information
| 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-010.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 354378 Full Announcement-RFA-NS-25-010 -> RFA-NS-25-010-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00286609 | Dec 24, 2024 | Jan 24, 2025 | View |
Package 1
Mandatory forms
354378 RR_SF424_5_0-5.0.pdf
354378 PHS398_CoverPageSupplement_5_0-5.0.pdf
354378 RR_OtherProjectInfo_1_4-1.4.pdf
354378 PerformanceSite_4_0-4.0.pdf
354378 RR_KeyPersonExpanded_4_0-4.0.pdf
354378 RR_Budget10_3_0-3.0.pdf
354378 PHS398_ResearchPlan_5_0-5.0.pdf
354378 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
354378 RR_SubawardBudget10_30_3_0-3.0.pdf
354378 PHS_AssignmentRequestForm_3_0-3.0.pdf
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