NOT-AG-24-084: Notice of Intent to Publish a Notice of Funding Opportunity for Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)

NOT-AG-24-084: Notice of Intent to Publish a Notice of Funding Opportunity for Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) is sponsored by National Institute on Aging (NIA). Intends to publish a funding opportunity for multi-site clinical trials of interventions for Alzheimer's disease using the ACTC infrastructure.

NOT-AG-24-084: Notice of Intent to Publish a Notice of Funding Opportunity for Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) Notice of Intent to Publish a Notice of Funding Opportunity for Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) Estimated Publication Date of Notice of Funding Opportunity : First Estimated Application Due Date: Earliest Estimated Award Date: Earliest Estimated Start Date: July 1, 2024 - Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required).

See NOFO RFA-AG-25-010 .

The National Institute on Aging intends to publish a Notice of Funding Opportunity (NOFO) to invite applications to develop and implement multi-site Phase Ib to III clinical trials of promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease (AD) and AD-related dementias (ADRD) using the Alzheimer's disease Clinical Trials Consortium (ACTC) trial coordination and management infrastructure.

This NOFO will be a reissue of RFA-AG-25-010 . This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The NOFO is expected to be published in December 2024 with expected application due dates in March 2025, June 2025, and October 2025.

This NOFO will utilize the R01 activity code. Details of the planned NOFO are provided below. Research Initiative Details To meet the congressionally mandated goal of preventing and treating AD/ADRD, it is critical that we have efficient mechanisms to fund clinical trials pursuing a variety of therapeutic targets and approaches to prevent, delay, and treat AD/ADRD.

The work of this NOFO will enable the early- to late-stage testing of promising pharmacological and non-pharmacological interventions that target deleterious cognitive and neuropsychiatric changes associated with age-related cognitive decline and AD/ADRD across the spectrum from pre-symptomatic to more severe stages of disease.

Utilizing the Alzheimer's disease Clinical Trials Consortium (ACTC), the goal of this NOFO is to invite research grant applications that provide clinical testing (Phases Ib-III) of promising pharmacological and/or non-pharmacological interventions for cognitive and neuropsychiatric symptoms in individuals with AD or other aging-related dementias across the spectrum from pre-symptomatic to more severe stages of disease.

Working with the ACTC is a collaborative venture between the applicant, NIA, and the ACTC network. NIA and the ACTC leadership will provide guidance to potential applicants. Potential applicants are strongly encouraged to contact NIA Scientific/Research Contacts and the ACTC study team in order to discuss the feasibility of conducting the proposed trial through the ACTC infrastructure before considering an application.

The ACTC infrastructure is welcoming of the following: Academic and industry applicants Pharmacological and non-pharmacological interventions Applications are encouraged that propose the following: Testing candidate therapeutic compounds against novel therapeutic targets Testing repurposed drugs derived from data-driven approaches, including candidates coming from NIA's translational bioinformatics programs ACTC Steering Committee Approval Potential applicants must have approval from the ACTC steering committee before an application to this NOFO can be submitted.

Initial vetting of the proposed study is conducted by the ACTC protocol evaluation committee, and final review is conducted by the ACTC steering committee. Members of the ACTC can propose trials utilizing the ACTC network. In this case, they are recused from the protocol evaluation committee voting process and the ACTC steering committee voting process.

Additionally, applicants in conflict are not present during the ACTC steering committee vote. Applicants should contact the ACTC study team at least 5 months prior to their desired NIA submission cycle. Contact details and more information may be found at actcinfo.

org . Applications should anticipate using a centralized IRB. Applicants should be aware of the data and resource sharing requirements.

The use of common contract language is strongly encouraged. Note, the ACTC infrastructure is not appropriate for: Single-site clinical trials Routine Phase Ia first-in-human trials Clinical trials funded from this NOFO will be implemented through the ACTC. The clinical trials approved for funding will develop their final protocols in conjunction with the ACTC.

All ACTC sites will have the option to request participation and will be selected based on their capabilities specific to the individual protocols. Investigators are strongly encouraged to collect blood and other biospecimens for future genomic and other 'omic' analyses aimed at interrogating treatment responsiveness and examining predictors of decline and progression.

Non-responsiveness Criteria The following types of applications will be considered non-responsive to the upcoming NOFO and will be administratively withdrawn prior to scientific peer review: Applications that do not have prior approval from the ACTC steering committee. Applications that propose single-site studies. Expected Number of Awards Application budgets are not limited but need to reflect the actual needs of the proposed project.

Primary Assistance Listing Number(s) Anticipated Eligible Organizations Public/State Controlled Institution of Higher Education Private Institution of Higher Education Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education) For-Profit Organization (Other than Small Business) Indian/Native American Tribal Government (Federally Recognized) Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments) U.S. Territory or Possession Indian/Native American Tribal Government (Other than Federally Recognized) Non-domestic (non-U.S.) Entity (Foreign Organization) Eligible Agencies of the Federal Government Applications are not being solicited at this time.

Please direct all inquiries to: Pharmacological Interventions National Institute on Aging (NIA) Non-Pharmacological Interventions National Institute on Aging (NIA) Weekly TOC for this Announcement NIH... Turning Discovery Into Health ®