Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementia...

Document Type:Grants NoticeFunding Opportunity Number:PAR-23-274Funding Opportunity Title:Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required)Opportunity Category:DiscretionaryOpportunity Category Explanation: Funding Instrument Type:Cooperative AgreementCategory of Funding Activity:HealthCategory Explanation: Expected Number of Awards: CFDA Number(s):93.866 -- Aging ResearchCost Sharing or Matching Requirement:No Version:Synopsis 1Posted Date:Aug 23, 2023Last Updated Date:Aug 23, 2023Original Closing Date for Applications:Nov 19, 2026 Current Closing Date for Applications:Nov 19, 2026 Archive Date:Dec 25, 2026Estimated Total Program Funding: Award Ceiling: Award Floor: Document Type:Grants NoticeFunding Opportunity Number:PAR-23-274Funding Opportunity Title:Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel

therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required)Opportunity Category:DiscretionaryOpportunity Category Explanation: Funding Instrument Type:Cooperative AgreementCategory of Funding Activity:HealthCategory Explanation: Expected Number of Awards: CFDA Number(s):93.866 -- Aging ResearchCost Sharing or Matching Requirement:No Version:Synopsis 1Posted Date:Aug 23, 2023Last Updated Date:Aug 23, 2023Original Closing Date for Applications:Nov 19, 2026 Current Closing Date for Applications:Nov 19, 2026 Archive Date:Dec 25, 2026Estimated Total Program Funding: Award Ceiling: Award Floor: Eligible Applicants:Others (see text field entitled "Additional Information on Eligibility" for clarification) Native American tribal governments (Federally recognized) County governments Public and State controlled institutions of higher education For profit organizations other than small businesses 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) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments Public housing authorities/Indian housing authorities Small businesses Independent school districts City or township governmentsAdditional 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. Agency Name:National Institutes of HealthDescription:The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development.Link to Additional Information:https://grants.nih.gov/grants/guide/pa-files/PAR-23-274.htmlGrantor Contact Information:If you have difficulty accessing the full announcement electronically, please contact: NIH Grants Information grantsinfo@nih.govSee Section VII. Agency Contacts within the full opportunity announcement for all other inquires.