The National Institutes of Health (NIH), through the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS), has issued a Notice of Funding Opportunity (NOFO) titled "Research on Current Topics in Alzheimer's Disease and Its Related Dementias" (R01 Clinical Trial Optional). This funding opportunity aims to support biomedical, social, and behavioral research focused on advancing understanding of Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). Specific high-priority research topics will be outlined in subsequent Notices of Special Interest (NOSIs) published under this NOFO.

The NOFO is designed to address critical gaps in AD/ADRD research and accelerate progress toward the prevention, treatment, and management of these conditions. Research efforts may include studies on disease heterogeneity, underlying pathophysiological mechanisms, risk and resilience factors, biomarkers, and therapeutic targets. Additionally, proposals may address health disparities, caregiver burden, and innovative intervention strategies. This initiative aligns with the National Alzheimer’s Project Act (NAPA) and recommendations from NIH AD/ADRD Research Summits, which emphasize interdisciplinary research and collaborative approaches.

Eligible applicants include higher education institutions, non-profits, for-profit organizations, state and local governments, tribal organizations, foreign entities, and other eligible organizations. Applications may be submitted by public and private institutions, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, and Tribal Colleges. Foreign organizations and non-U.S. components of U.S. institutions are also eligible to apply.

The funding opportunity allows for new, renewal, resubmission, and revision applications. Budgets are not capped but must reflect the actual needs of the proposed project, with a maximum project period of five years. Applications may include NIH-defined clinical trials but must adhere to NIH's guidelines for human subjects research, including requirements for diversity and inclusivity in participant recruitment. Investigators are encouraged to utilize resources such as NIA’s OutreachPro for recruitment materials and the Clinical Research Operations and Management System (CROMS) for clinical trial management.

Applications will be evaluated based on scientific merit, innovation, feasibility, and alignment with program priorities. Key review criteria include the significance of the research, the rigor and feasibility of the approach, the expertise of the investigative team, and the adequacy of the proposed resources and environment. Additional considerations include data management and sharing plans, adherence to human subjects and animal welfare regulations, and alignment with health disparity priorities.

Letters of intent are not required, and applications must be submitted electronically through Grants.gov. Standard NIH due dates apply, with cycles starting in March, June, October, and February of each year through November 2027. Applicants are encouraged to submit their proposals early to ensure compliance with submission requirements.

Key contacts for technical assistance include designated Scientific/Research, Peer Review, and Financial/Grants Management representatives from NIA and NINDS. Successful applicants will receive Notices of Award (NoA), and awardees must comply with NIH reporting and data-sharing policies. This NOFO underscores NIH's commitment to advancing research that addresses the multifaceted challenges of AD/ADRD and improving health outcomes for affected populations.