Early Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) | PAR 18 877

Opportunity Information: Apply for PAR 18 877

Early Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity (PAR 18-877) designed to support early clinical testing of interventions aimed at preventing, slowing, or improving cognitive decline associated with aging and Alzheimers disease. The program focuses on early stage clinical trials, specifically Phase I and Phase II studies, and it is intended to move promising ideas into well-structured human testing. The overall goal is to accelerate development of both drug-based (pharmacological) and non-drug (non-pharmacological) approaches that could meaningfully affect cognition, function, or disease progression, while also encouraging work that improves how these trials are designed and executed.

A key feature of this FOA is the breadth of the target population. Proposed trials can involve individuals experiencing age-related cognitive decline as well as people across the full Alzheimers continuum, ranging from pre-symptomatic or preclinical stages (when biological changes may be present but daily function is largely intact) through mild and more advanced stages of disease. This wide scope is meant to support a pipeline of studies that match interventions to the stage where they may be most effective, whether that is prevention-oriented work in earlier stages or symptom- or function-oriented approaches in later stages.

The FOA explicitly welcomes applications that not only test interventions but also strengthen the science of clinical trials in this space. In practice, that means projects can emphasize improvements in trial design and methodology, such as better outcome measures, stronger recruitment and retention approaches, improved statistical or operational methods, or strategies that make early stage trials more informative and efficient. The intent is to raise the quality and interpretability of early human studies so that subsequent, larger confirmatory trials can be better justified and better designed.

The funding mechanism is the NIH R01 grant, and the announcement is labeled "Clinical Trial Optional," indicating that applicants may propose a clinical trial but are not strictly required to do so under this specific listing. The funding instrument type is a discretionary grant, and the activity category falls under Education and Health. The associated CFDA numbers are 93.361 and 93.866, which correspond to NIH programs related to aging and neurological disorders. The opportunity was created on 2018-07-26, and the original closing date listed is 2022-01-07. The provided source data does not specify an award ceiling or the expected number of awards, suggesting applicants would need to refer to the full FOA text or NIH program staff for budget expectations and typical award patterns.

Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts. Higher education institutions are eligible on both the public/state-controlled and private side. Tribal participation is supported through eligibility for federally recognized Native American tribal governments as well as Native American tribal organizations that are not federally recognized. Housing-related public authorities (including Indian housing authorities) are also listed. The FOA allows applications from nonprofits both with and without 501(c)(3) status (outside institutions of higher education), and it also permits for-profit organizations (other than small businesses) and small businesses. In addition, NIH highlights that other eligible applicants include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-domestic (non-U.S.) entities (foreign organizations). This mix signals an interest in encouraging diverse institutional participation and potentially supporting trials that can reach varied communities and settings.

In practical terms, a competitive application under this FOA would be expected to propose a credible early stage trial plan or a strong trial-methods project relevant to Alzheimers disease and age-related cognitive decline, with careful attention to participant population (including disease stage), intervention rationale, feasibility, safety monitoring appropriate for Phase I/II work, and outcome measurement that can demonstrate whether the approach is promising enough for larger-scale testing. Since the FOA explicitly includes both pharmacological and non-pharmacological interventions, proposals may span therapeutics, devices, behavioral interventions, lifestyle approaches, cognitive training, care delivery strategies, or other clinically testable methods, as long as the work is framed as an early stage clinical evaluation or a meaningful enhancement to the way such trials are conducted.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Early Stage Clinical Trials for the Spectrum of Alzheimers Disease 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): 93.361, 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 18 877

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