Late Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Required) | PAR 18 878

Opportunity Information: Apply for PAR 18 878

The grant opportunity titled "Late Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Required)" is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) that supports large, late-stage clinical studies aimed at improving outcomes for people experiencing age-related cognitive decline and for individuals across the full continuum of Alzheimers disease (AD). The emphasis is on taking interventions that are already promising and moving them into Phase II/III or Phase III testing, meaning applicants are expected to propose trials that are relatively advanced in development and focused on demonstrating efficacy and safety (or confirming benefit) in well-defined patient populations. The FOA explicitly includes both pharmacological approaches (such as drugs or biologics) and non-pharmacological approaches (such as behavioral interventions, lifestyle programs, cognitive training, care delivery models, or other non-drug strategies), as long as they are suitable for rigorous late-stage clinical trial evaluation.

A key feature of this FOA is that it requires an R01 application that includes a clinical trial. In practical terms, this means the project must be structured as a true clinical trial with prospective assignment to an intervention, a defined comparison condition (such as placebo, standard of care, or an alternative intervention), and clearly articulated clinical and/or biomarker outcomes. The target populations span from pre-symptomatic individuals (for example, those at risk or with early biological signs) through people with more advanced symptomatic disease. The intent is to support research that can credibly influence clinical practice and patient care by generating high-quality evidence in real-world-relevant populations across different stages of cognitive impairment and AD progression.

The FOA is categorized as discretionary funding and uses the grant mechanism, specifically the NIH R01 research project grant. The activity category is health, and it is associated with CFDA number 93.866. The opportunity number is PAR-18-878, with an original closing date listed as 2022-01-07 and a creation date of 2018-07-26. The listing does not specify an award ceiling or the expected number of awards in the provided source details, which often means applicants would need to consult the full FOA text and NIH institute guidance for budget expectations, project periods, and institute-specific funding plans.

Eligibility is broad and includes many types of applicants that can carry out complex clinical trials. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and public housing authorities or Indian housing authorities. Academic institutions are eligible, including public and state-controlled institutions of higher education and private institutions of higher education. Tribal entities are included, such as federally recognized Native American tribal governments, as well as Native American tribal organizations other than federally recognized tribal governments. The FOA also allows nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations other than small businesses, and small businesses. NIH also highlights additional eligible applicant categories that underscore an interest in inclusion and broad participation, including 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility aligns with the reality that late-stage AD and cognitive decline trials often benefit from multi-site networks, community engagement, diverse recruitment catchment areas, and specialized clinical research infrastructure.

Overall, this opportunity is geared toward teams ready to run rigorous, later-phase trials that can test whether an intervention meaningfully prevents cognitive decline, slows progression, improves cognition or function, or otherwise benefits patients and families across the AD spectrum. Competitive applications would typically be expected to demonstrate strong scientific rationale and preliminary evidence, a feasible and ethically sound trial design, robust recruitment and retention plans (often with attention to representativeness and inclusion), well-justified endpoints, and clear operational capabilities for conducting high-quality Phase II/III or Phase III clinical research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Late Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (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 2018-07-26.
• Applicants must submit their applications by 2022-01-07. (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 18 878

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