Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) | RFA AG 25 010

Opportunity Information: Apply for RFA AG 25 010

The Alzheimer’s Clinical Trials Consortium (ACTC) Clinical Trials opportunity (RFA-AG-25-010) is a National Institutes of Health (NIH) grant program that supports the development and execution of multi-site clinical trials focused on Alzheimer’s disease (AD) and other age-related dementias. The central purpose is to move promising interventions forward by funding Phase Ib through Phase III studies that test whether a treatment can prevent the onset of disease, delay progression, or improve symptoms. The scope is intentionally broad in terms of what can be tested, covering both pharmacological approaches (for example, drugs or biologics) and non-pharmacological approaches (for example, behavioral, lifestyle, device-based, care-delivery, or other structured interventions), as long as the project is a bona fide clinical trial in the supported phase range.

A defining feature of this NOFO is its requirement to conduct the trial through the established Alzheimer’s Disease Clinical Trials Consortium infrastructure. In practice, this means applicants are expected to leverage ACTC’s trial coordination and management capabilities for activities that typically make multi-site studies feasible at scale, such as centralized operational support, site coordination, trial management processes, and other consortium-based efficiencies. The emphasis on ACTC reflects a goal of improving consistency, quality, and speed in trial execution across multiple sites, while also helping studies reach appropriate enrollment and operational milestones.

The funding mechanism is an R01 grant with a “Clinical Trial Required” designation, meaning the application must propose a clinical trial rather than purely observational research or preclinical work. The opportunity is categorized as discretionary grant funding within the health area and is listed under CFDA (Assistance Listing) 93.866. The program is aimed at trials substantial enough to warrant an R01 structure, particularly those that require multi-site implementation and the more complex oversight typical of Phase Ib to Phase III studies.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The NOFO also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and non-domestic (non-U.S.) entities (foreign organizations). This broad eligibility language signals an interest in drawing from a wide range of research, clinical, and community partners that can contribute to recruitment, implementation, and generalizability across diverse populations and settings.

Key administrative details provided in the source include the funding opportunity title and number (RFA-AG-25-010), the sponsoring agency (NIH), and an original closing date of 2024-10-17. The posted record does not specify an award ceiling or expected number of awards in the excerpted fields, so applicants would typically confirm budget limits, project period expectations, and award projections in the full NOFO text and any related NIH guidance. Overall, the opportunity is designed for teams prepared to run rigorous, multi-site mid- to late-stage clinical trials in AD and related dementias, using ACTC as the operational backbone to support high-quality trial execution.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2024-07-01.
• Applicants must submit their applications by 2024-10-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AG 25 010

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