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 Institute on Aging (NIA), part of the U.S. Department of Health and Human Services under the National Institutes of Health (NIH), has issued a forecasted grant opportunity titled "Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline." This grant, identified by the opportunity number FOR-RFA-AG-26-020, is categorized as a discretionary funding opportunity within the area of health research. The primary focus of the grant is to support the development and implementation of clinical trials for interventions—both pharmacological and non-pharmacological—that address the cognitive, behavioral, and neuropsychiatric symptoms associated with aging, Alzheimer’s disease (AD), and Alzheimer’s disease-related dementias (ADRD). This forecasted Notice of Funding Opportunity (NOFO) is expected to support clinical trial research at various stages, from early to late development. The ultimate goal is to identify interventions that can prevent or treat age-related cognitive decline and dementia-related conditions. Additionally, the grant aims to encourage the advancement of clinical trial methodology, seeking innovative approaches to trial design, participant recruitment, data analysis, and outcome measurement. The NOFO will use the NIH Research Project Grant (R01) activity code, signaling an emphasis on rigorous, investigator-initiated research efforts that align with national aging and cognitive health priorities. Although applications are not currently being solicited, this early forecast allows prospective applicants ample time to assemble multidisciplinary teams, gather preliminary data, and refine their proposals. The grant opportunity anticipates a publication date of August 1, 2025, with applications due by October 5, 2025. Projects are expected to begin July 1, 2026, with awards being announced by the same date. While no total funding amount, ceiling, or floor has been provided, these details are expected to be clarified upon the release of the final NOFO. Eligibility for this funding opportunity is extensive. Qualified applicants include public housing authorities, Indian housing authorities, public and private institutions of higher education, small businesses, state and local governments, county governments, independent school districts, Native American tribal governments and organizations (both federally recognized and not), nonprofit organizations with 501(c)(3) status, and for-profit organizations excluding small businesses. This wide eligibility ensures diverse institutional participation in the development of AD/ADRD interventions, including those serving underrepresented populations. Cost sharing or matching is not required for this opportunity. The grant falls under Assistance Listing Number 93.866, focused on Aging Research. Interested applicants are encouraged to begin preparing their submissions, particularly those with research experience or an operational focus in geriatric neurology, cognitive aging, or related fields. The program is forecasted to recur, suggesting ongoing opportunities in future fiscal years. For questions or additional information regarding the forecasted NOFO, applicants may contact Dr. Laurie Ryan at the National Institute on Aging. She can be reached by phone at 301-496-9350 or via email at ryanl@mail.nih.gov. This pre-announcement facilitates advanced planning for a competitive application process that aligns with the strategic goals of the NIA to address cognitive health challenges in the aging population.