Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) | PAR 20 309

Opportunity Information: Apply for PAR 20 309

The Alzheimer’s Clinical Trials Consortium (ACTC) Clinical Trials funding opportunity (PAR-20-309) is an NIH grant program that supports the development and execution of Phase Ib through Phase III clinical trials focused on Alzheimer’s disease and other age-related dementias. The central aim is to move promising interventions into well-run human studies that can determine whether those interventions can prevent the onset of disease, delay progression, or treat symptoms. Importantly, this announcement is specifically for projects that will run an actual clinical trial under an R01 mechanism, meaning applicants are expected to propose a fully developed trial concept with clear clinical endpoints, a feasible operational plan, and the ability to meet the scientific and regulatory requirements associated with interventional human subjects research.

A defining feature of this FOA is that supported trials are expected to use the ACTC’s trial coordination and management infrastructure. In practical terms, the ACTC provides an established platform to help investigators conduct complex Alzheimer’s and dementia trials more efficiently and consistently across sites. That infrastructure can include trial operations support, coordination among participating clinical sites, trial management processes, and other centralized resources that improve quality and execution. The opportunity is designed to take advantage of a standing consortium so that research teams do not have to build all trial infrastructure from scratch, and so that studies are run using harmonized procedures that are common in large, multisite dementia trials.

The program welcomes a broad range of interventions, including both pharmacological approaches (for example, drug therapies or biologics) and non-pharmacological approaches (for example, behavioral, lifestyle, device-based, or care-delivery interventions, as long as they fit the clinical trial framework). The scope spans trials intended for prevention (aimed at reducing risk or delaying onset), delay (slowing progression in early or prodromal stages), and treatment (addressing symptoms or modifying disease course). Because the eligible trial phases range from Ib to III, the FOA can support studies that refine dosing and safety in a target population as well as later-stage trials designed to test efficacy and inform practice.

Eligibility under this announcement is intentionally expansive and includes many types of U.S. organizations and institutions: state, county, and local governments; special district governments; independent school districts; public housing authorities and Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (including those other than small businesses); and small businesses. It 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, Tribally Controlled Colleges and Universities, and other tribal entities (including tribal governments that are not federally recognized). Faith-based or community-based organizations may apply, and certain non-U.S. (foreign) entities and regional organizations are also listed as eligible, along with U.S. territories or possessions and eligible federal agencies. This wide eligibility reflects a goal of drawing strong clinical trial proposals from a diverse set of research, health system, and community-connected organizations, which can be particularly relevant for improving recruitment and representation in dementia research.

Administratively, this is a discretionary grant program administered by the National Institutes of Health, using the R01 funding instrument, and it is tied to CFDA number 93.847. The FOA was created on 2020-11-24, and the listed original closing date in the provided source is 2024-05-07. The source information provided does not specify an award ceiling or the expected number of awards, which typically means applicants need to consult the full FOA details and NIH guidance to understand budget expectations, project period limits, and any institute-specific considerations.

Overall, this opportunity is aimed at teams ready to conduct rigorous, later-stage interventional studies in Alzheimer’s disease and related dementias, with the added advantage and expectation that trials will be carried out using the ACTC’s established coordination and management framework. The intent is to accelerate high-quality clinical testing of interventions that could meaningfully change prevention strategies, slow decline, or improve symptoms for people affected by these conditions.

• The National Institutes of Health in the food and nutrition, 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): 93.847.
• This funding opportunity was created on 2020-11-24.
• Applicants must submit their applications by 2024-05-07. (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 PAR 20 309

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