Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline

The National Institutes of Health (NIH), through its National Institute on Aging (NIA), intends to issue a Notice of Funding Opportunity (NOFO) for clinical research targeting Alzheimer's disease (AD), Alzheimer's disease-related dementias (ADRD), and age-related cognitive decline. As a forecasted opportunity under reference number FOR-RFA-AG-26-020, the funding will support early- to late-stage clinical trials evaluating pharmacological and non-pharmacological interventions. The NIH is the primary agency of the United States government responsible for biomedical and public health research, and the NIA specifically leads efforts related to the biology of aging and age-associated diseases. This upcoming NOFO will use the R01 activity code, which is typically associated with Research Project Grants. The objective of the funding is twofold: first, to encourage the development and implementation of novel interventions to prevent or treat the spectrum of cognitive, behavioral, and neuropsychiatric symptoms linked to AD, ADRD, and cognitive aging; second, to stimulate methodological studies aimed at enhancing clinical trial design, efficiency, and effectiveness. Though applications are not being accepted at this stage, the notice serves to give interested parties ample time to assemble collaborative teams and develop robust proposals. The funding will be structured as discretionary grants, with an anticipated post date of August 1, 2025. Applications are estimated to be due by October 5, 2025. Successful applicants would likely receive award notifications by July 1, 2026, with projects beginning on that same date. No award floor, ceiling, or total program funding information has yet been disclosed, and the expected number of awards is also unspecified. The opportunity falls under Assistance Listing 93.866, which relates to Aging Research. Eligible applicants span a wide array of organization types, including federally and non-federally recognized tribal governments, Native American tribal organizations, state and county governments, public and private institutions of higher education, public housing authorities, independent school districts, nonprofits with 501(c)(3) status (excluding institutions of higher education), small businesses, and for-profit organizations other than small businesses. This broad eligibility scope indicates the NIH’s interest in fostering diverse research participation across institutional types and regions. This opportunity is forecasted, meaning it is in a planning stage and has not yet opened for applications. It is not a rolling opportunity, but it may recur annually or periodically—specific recurrence language is not yet available. The forecast was most recently updated on June 27, 2025. The main point of contact for this funding opportunity is Laurie Ryan, Ph.D., at the National Institute on Aging, who can be reached via phone at 301-496-9350 or by email at ryanl@mail.nih.gov. Interested parties should monitor Grants.gov and the NIH website for updates regarding the official release of the NOFO. While no pre-application deadlines or Q&A opportunities have been listed yet, early coordination and preparation are encouraged given the complexity and scope of the proposed clinical trials. Final details regarding the evaluation criteria and required documentation will be outlined when the official solicitation is posted.