Early and Late Stage Clinical Trials for the Spectrum of Alzheimers Disease/Alzheimers Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional) | PAR 23 081

Opportunity Information: Apply for PAR 23 081

This grant opportunity (PAR 23-081) from the National Institutes of Health is an R01 research project grant focused on advancing clinical trials for interventions targeting age-related cognitive decline and the full spectrum of Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD). The main goal is to support projects that move promising treatment or prevention strategies forward by developing and carrying out early-stage through late-stage clinical trials. The FOA is intentionally broad about where a study can fall on the disease timeline, encouraging trials that address people who are pre-symptomatic as well as those with more advanced impairment, as long as the work is clearly tied to cognitive and/or neuropsychiatric changes associated with aging and AD/ADRD.

A key feature of the announcement is its emphasis on both pharmacological and non-pharmacological approaches. On the pharmacological side, this could include drugs, biologics, or other therapeutic agents aimed at modifying disease processes or improving symptoms. On the non-pharmacological side, it may include behavioral interventions, cognitive training, lifestyle and multi-domain programs, technology-enabled supports, caregiver- or system-level interventions, and other strategies designed to prevent decline, slow progression, or improve quality of life. The FOA is interested not only in whether an intervention works, but also in how it affects outcomes that matter in real life, especially cognition and neuropsychiatric symptoms, which can include changes in mood, behavior, agitation, apathy, sleep, or other psychiatric and behavioral features commonly seen in dementia-related conditions.

In addition to funding trials themselves, the opportunity explicitly aims to strengthen the science of clinical trials in this field by stimulating studies that improve trial design and methods. In practice, this means applicants can propose work that makes trials more informative, efficient, or feasible, such as improving recruitment and retention strategies, developing better outcome measures or endpoints, refining statistical or adaptive designs, validating biomarkers or digital measures for use in trials, addressing heterogeneity across AD/ADRD populations, or improving approaches for studying different stages of disease. The overall intent is to make future trials more likely to yield clear answers and to accelerate progress toward effective interventions.

The funding mechanism is a discretionary NIH grant (R01), categorized under health research and associated with CFDA number 93.866. The FOA is labeled "Clinical Trial Optional," which generally indicates that applicants may propose a project that includes a clinical trial, but they are not strictly required to do so, as long as the proposed work fits the FOA's goals. That said, the central focus of the announcement is on developing and implementing clinical trials across early to late stages, so applications are expected to be closely aligned with clinical trial planning, execution, or trial-focused methods development.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) entities. This breadth signals an interest in drawing from diverse research settings and community contexts, which can be especially important for AD/ADRD trials where participant diversity, caregiver involvement, and real-world implementation challenges often determine whether findings translate beyond a single clinic or region.

From an administrative standpoint, the opportunity was created on December 23, 2022, and lists an original closing date of January 7, 2025. The provided source data does not specify an award ceiling or the expected number of awards, which usually means applicants should refer to the full FOA text and NIH institute guidance for budget expectations, scope alignment, and any institute-specific priorities. Overall, the program is designed to push the field toward better-tested interventions and better ways of running trials, with the ultimate aim of improving prevention, treatment, and care for cognitive and neuropsychiatric challenges related to aging and AD/ADRD.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Early and Late Stage Clinical Trials for the Spectrum of Alzheimers Disease/Alzheimers Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)" 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 2022-12-23.
• Applicants must submit their applications by 2025-01-07. (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 23 081

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