Notice of Intent to Publish a Notice of Funding Opportunity for Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)

The National Institute on Aging (NIA) plans to publish a Notice of Funding Opportunity (NOFO) to support multi-site Phase Ib to III clinical trials focused on promising pharmacological and non-pharmacological interventions for Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). These trials aim to prevent, delay, or treat symptoms associated with AD and ADRD and will leverage the Alzheimer’s Clinical Trials Consortium (ACTC) trial coordination and management infrastructure. This initiative seeks to facilitate large-scale, rigorous clinical trials across multiple sites, utilizing the ACTC platform to ensure efficient coordination, resource sharing, and high-quality data collection. The supported interventions may range from novel pharmaceutical therapies to behavioral and lifestyle approaches that address disease progression, symptom management, and overall quality of life for affected individuals. The NOFO will utilize the R01 activity code, which supports investigator-initiated research projects with clear scientific objectives and well-defined methodologies. Eligible applicants include state and county governments, public and private higher education institutions, Native American tribal governments and organizations, independent school districts, small businesses, nonprofits with 501(c)(3) status, for-profit organizations other than small businesses, and public housing authorities. The funding opportunity emphasizes collaborative and multidisciplinary research teams capable of addressing the complex nature of AD and ADRD clinical trials. Proposals are expected to demonstrate robust scientific design, feasibility, and alignment with NIA’s overarching mission to advance research and improve outcomes for individuals affected by these diseases. The anticipated publication date for this NOFO is December 2024, with application due dates expected in March 2025, June 2025, and October 2025. The earliest project start date is projected for December 1, 2025. This advance notice is provided to allow prospective applicants adequate time to establish collaborations, refine research strategies, and prepare competitive proposals.