Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) | PAR 18 513

Opportunity Information: Apply for PAR 18 513

The Alzheimer’s Clinical Trials Consortium (ACTC) Clinical Trials opportunity (PAR-18-513) is a National Institutes of Health (NIH) grant announcement that supports the design, launch, and execution of Phase I through Phase III clinical trials aimed at Alzheimer’s disease (AD) and other age-related dementias. The core purpose is to move promising interventions into well-run human studies that can show whether a treatment can prevent cognitive decline, delay the onset or progression of symptoms, or improve symptoms once they appear. The announcement explicitly allows both pharmacological approaches (for example, drugs or biologics) and non-pharmacological approaches (for example, behavioral, lifestyle, cognitive, device-based, or care-delivery interventions), as long as the project is a true clinical trial and fits within the early- to late-stage trial spectrum covered by Phases I to III.

A defining feature of this program is that applicants are expected to run their trials using the ACTC trial coordination and management infrastructure. In practical terms, that means the clinical trial is not envisioned as a standalone effort built from scratch at a single institution; instead, it is meant to leverage a dedicated consortium platform that can provide established operational support for things like trial start-up, site coordination, enrollment management, data collection and management, quality oversight, and general trial operations. The intent is to reduce redundancy, speed up trial implementation, and increase the consistency and rigor of AD and dementia trials by relying on a centralized, experienced clinical trials network.

The funding mechanism is the NIH R01, and the announcement states “Clinical Trial Required,” meaning the application must propose a clinical trial rather than only preclinical work, observational research, or trial planning without actual participant intervention and outcomes evaluation. The activity category is health, and the opportunity is listed under CFDA 93.866. While the summary information provided does not include an award ceiling or the number of expected awards, the emphasis is clearly on supporting interventional studies that are ready to be executed within the ACTC operational framework, rather than exploratory ideas that are not yet trial-ready.

Eligibility is broad and includes a wide range of domestic organizations: state, county, city, township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments. It also includes nonprofit organizations both with and without 501(c)(3) status (other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and even non-domestic (non-U.S.) entities (foreign organizations). Taken together, this suggests NIH is encouraging participation from a diverse set of institutions and communities, which is especially relevant in Alzheimer’s research where representative recruitment and inclusive trial access are longstanding needs.

Key administrative details in the source data include the original posting timeframe and close date: the FOA was created on 2017-12-18, and the original closing date listed is 2020-11-24. The awarding agency is NIH, and the instrument is a grant under a discretionary funding opportunity. Overall, the opportunity is best understood as a pathway for investigators and organizations to bring strong candidate interventions into rigorously managed clinical testing for Alzheimer’s disease and related dementias, using the established ACTC infrastructure to improve trial efficiency, consistency, and execution quality.

• 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 2017-12-18.
• Applicants must submit their applications by 2020-11-24. (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 18 513

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