Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)

Background
The National Institutes of Health (NIH) and the National Institute on Aging (NIA) are issuing the Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) grant opportunity. The goal is 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 other age-related dementias using the ACTC trial coordination and management infrastructure.

Grant Details
Utilizing the ACTC, the goal 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. The ACTC infrastructure is welcoming of academic and industry applicants proposing testing candidate therapeutic compounds against novel therapeutic targets, repurposed drugs derived from data-driven approaches, including candidates coming from NIA's translational bioinformatics programs. Potential applicants must have approval from the ACTC steering committee before an application to this NOFO can be submitted. 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.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, federal governments, U.S. Territory or Possession, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations, regional organizations, foreign organizations, and foreign components of U.S. Organizations. Foreign Organizations are eligible to apply. Non-domestic components of U.S. Organizations are allowed to apply.

Period of Performance
The period of performance is expected to start on October 17, 2024 and may extend up to five years.

Grant Value
NIA will commit approximately $10,000,000 to support multi-site clinical trials of varying size and scope in FY 2025. Application budgets are not limited but need to reflect the actual needs of the proposed project.