Notice of Intent to Publish a Notice of Funding Opportunity for Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)
This funding opportunity supports clinical trials for innovative treatments and interventions targeting Alzheimer's disease, related dementias, and age-related cognitive decline, inviting applications from a wide range of eligible organizations, including universities, nonprofits, and small businesses.
Description
The National Institute on Aging (NIA) plans to publish a Notice of Funding Opportunity (NOFO) to invite applications for early- to late-stage clinical trials focused on pharmacological and non-pharmacological interventions aimed at preventing and/or treating cognitive, behavioral, and neuropsychiatric symptoms associated with age-related cognitive decline, Alzheimer’s disease (AD), and Alzheimer’s disease-related dementias (ADRD). The NOFO also aims to encourage studies designed to enhance trial design and methods.
This initiative will support a range of clinical trials, from early-stage trials investigating novel interventions to late-stage trials assessing the efficacy and safety of these interventions. Both pharmacological approaches, such as medications or biologics, and non-pharmacological approaches, including behavioral interventions or lifestyle modifications, will be considered. Additionally, proposals that address methodological challenges in clinical trial design, such as participant recruitment, retention, and outcome measurement, are encouraged.
The funding opportunity will utilize the R01 activity code, which supports research projects conducted by investigators with the freedom to develop their proposed research approaches. The NOFO is expected to emphasize innovative trial designs, robust methodologies, and the potential for meaningful impacts on patient care and public health. Collaborative projects that bring together multidisciplinary teams to address the complex challenges of AD and ADRD research are highly encouraged.
Eligible applicants will include state and county governments, public and private higher education institutions, Native American tribal governments and organizations, public housing authorities, independent school districts, small businesses, nonprofits with 501(c)(3) status, and for-profit organizations other than small businesses. Proposals must demonstrate strong scientific rationale, feasibility, and alignment with NIA’s mission to reduce the burden of AD, ADRD, and age-related cognitive decline.
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 intended to give prospective applicants sufficient time to build collaborative partnerships and prepare responsive proposals.