The National Institute on Aging (NIA) is offering this grant to fund a pivotal Phase 3 clinical trial focusing on mixed dementia. This grant is for determining the efficacy and safety of FDA-approved monoclonal antibody therapy compared to placebo in diverse populations exhibiting both Alzheimer’s biomarkers and vascular pathology. Mixed dementia cases include those with positive amyloid PET/CSF amyloid beta 42 combined with elevated phosphorylated tau, alongside imaging evidence of white matter disease or subclinical infarction. Applications must propose well-powered studies to ensure efficacy determination across diverse U.S. populations, considering sex, race/ethnicity, and geographic distribution. Essential components include robust patient and community engagement cores integrated at all program levels.
Opportunity ID: 350646
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-24-013 |
| Funding Opportunity Title: | 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) |
| 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 2 |
| Posted Date: | Oct 20, 2023 |
| Last Updated Date: | May 15, 2024 |
| Original Closing Date for Applications: | Feb 20, 2024 |
| Current Closing Date for Applications: | Jun 13, 2024 |
| Archive Date: | Jul 13, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,700,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education County governments City or township governments Private institutions of higher education Small businesses Independent school districts Public housing authorities/Indian housing authorities Special district governments Native American tribal governments (Federally recognized) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses |
| 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 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-013.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 |
|---|---|---|
| Changing close date per issuance of NOT-NS-24-082 | May 15, 2024 | |
| Oct 20, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-24-013 |
| Funding Opportunity Title: | 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) |
| 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 2 |
| Posted Date: | Oct 20, 2023 |
| Last Updated Date: | May 15, 2024 |
| Original Closing Date for Applications: | Feb 20, 2024 |
| Current Closing Date for Applications: | Jun 13, 2024 |
| Archive Date: | Jul 13, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,700,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education County governments City or township governments Private institutions of higher education Small businesses Independent school districts Public housing authorities/Indian housing authorities Special district governments Native American tribal governments (Federally recognized) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses |
| 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 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-013.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-24-013 |
| Funding Opportunity Title: | 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) |
| 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: | Oct 20, 2023 |
| Last Updated Date: | Oct 20, 2023 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 20, 2024 |
| Archive Date: | Mar 27, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,700,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Independent school districts Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) 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 Special district 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 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-013.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 |
Related Documents
Folder 350646 Full Announcement-RFA-NS-24-013 -> RFA-NS-24-013-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 after January 25, 2023 | PKG00283563 | Jan 20, 2024 | Jun 13, 2024 | View |
Package 1
Mandatory forms
350646 RR_SF424_5_0-5.0.pdf
350646 PHS398_CoverPageSupplement_5_0-5.0.pdf
350646 RR_OtherProjectInfo_1_4-1.4.pdf
350646 PerformanceSite_4_0-4.0.pdf
350646 RR_KeyPersonExpanded_4_0-4.0.pdf
350646 RR_Budget10_3_0-3.0.pdf
350646 PHS398_ResearchPlan_5_0-5.0.pdf
350646 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
350646 RR_SubawardBudget10_30_3_0-3.0.pdf
350646 PHS_AssignmentRequestForm_3_0-3.0.pdf
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