The funding opportunity from the Department of Health and Human Services focuses on the Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials, specifically inviting applications for multi-site Phase Ib to III clinical trials that aim to develop pharmacological and non-pharmacological interventions for preventing, delaying, or treating symptoms of Alzheimer’s disease (AD) and other age-related dementias. This initiative is part of the National Institutes of Health (NIH) and is specifically managed by the National Institute on Aging (NIA). The application process opens on September 16, 2024, with a deadline for submissions set for October 17, 2024. Eligible applicants include a broad range of organizations, such as higher education institutions, nonprofits, and for-profit organizations, emphasizing the importance of diverse participation in this critical research area.
The primary objective of this funding opportunity is to leverage the ACTC infrastructure to conduct clinical trials evaluating interventions targeting cognitive and neuropsychiatric symptoms associated with Alzheimer's and other dementias at various stages of the disease. Applicants are encouraged to collaborate closely with the ACTC to discuss the feasibility of their proposed trials prior to submission, as prior approval from the ACTC steering committee is required for applications to be deemed responsive. While there is no cap on the application budgets, they must accurately reflect the project's needs, with NIA committing approximately $10 million for these efforts in FY 2025. The maximum project duration is five years, allowing for extensive research and development.
Applications will undergo a rigorous review process based on criteria such as scientific significance, innovation, approach, and the qualifications of the investigators involved. Reviewers will provide an overall impact score that reflects the project's potential influence on research fields. Additionally, proposals must address inclusivity, ensuring the participation of diverse populations that are often underrepresented in clinical research. Awardees will also be required to adhere to data sharing policies, facilitating the timely availability of participant-level and summary-level data following the completion of trials. Furthermore, all research protocols must receive approval from the appropriate Institutional Review Board to safeguard participant welfare throughout the research process.
