This department is offering funding for experienced investigators to conduct exploratory clinical trials testing new treatments for patients with Lewy Body Dementia (LBD). The trials may include Phase I or Phase II trials and must involve patients with LBD. Proposed therapies can be novel medications, devices, or existing treatments not yet approved for LBD patients. The focus is on preventing disease progression, alleviating clinical symptoms, and exploring potential benefits for LBD patients. The closing date for applications is Nov 21, 2022.
Opportunity ID: 340454
General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-NS-22-056 |
| Funding Opportunity Title:: | Treatments for Lewy Body Dementias and Frontotemporal Dementias–Exploratory Clinical Trial (U01 Clinical Trial Required) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Education |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 93.279 — Drug Abuse and Addiction Research Programs |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 1 |
| Posted Date:: | May 16, 2022 |
| Last Updated Date:: | May 17, 2022 |
| Original Closing Date for Applications:: | Nov 21, 2022 |
| Current Closing Date for Applications:: | Nov 21, 2022 |
| Archive Date:: | Dec 27, 2022 |
| Estimated Total Program Funding:: | |
| Award Ceiling:: | $400,000 |
| Award Floor:: | $ |
Eligibility
| Eligible Applicants:: | Nonprofits that do not have 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 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 allowed. |
Additional Information
| Agency Name:: | National Institutes of Health |
| Description:: | This Funding Opportunity Announcement invites applications from experienced investigators seeking to conduct exploratory clinical trials designed to test new treatments for patients with Lewy Body Dementia (LBD). Applicants may propose to conduct either Phase I or Phase II clinical trials depending on the developmental stage of the potential therapeutic, but all trials must include patients with LBD. Proposed therapies may include novel medications or devices, or existing treatments that are potentially beneficial but not currently approved for use in patients with LBD. Treatments intended to prevent or delay disease progression in LBD patients, as well as therapies to alleviate existing motor or non-motor clinical symptoms, are of interest. |
| Link to Additional Information:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 | May 17, 2022 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | |
| Competition ID: | FORMS-G |
| Competition Title: | Use for due dates on or after January 25, 2022 |
| Opportunity Package ID: | PKG00274370 |
| Opening Date: | Oct 21, 2022 |
| Closing Date: | Nov 21, 2022 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] PHS 398 Research Plan [V4.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
Research & Related Budget [V3.0] R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS 398 Modular Budget [V1.2] PHS Assignment Request Form [V3.0] |
Package No: 2
| Assistance Listings: | |
| Competition ID: | FORMS-H |
| Competition Title: | Use for due dates on or after January 25, 2023 |
| Opportunity Package ID: | PKG00277992 |
| Opening Date: | Nov 04, 2022 |
| Closing Date: | Nov 21, 2022 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] PHS 398 Research Plan [V5.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
Research & Related Budget [V3.0] R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS 398 Modular Budget [V1.2] PHS Assignment Request Form [V3.0] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00274370 | Oct 21, 2022 | Nov 21, 2022 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277992 | Nov 04, 2022 | Nov 21, 2022 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |