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.Apply for PAR 18 877
- 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.
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Early Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)" and it is associated with NIH funding opportunity announcement PAR 18-877.
What agency is offering this grant?
This is a National Institutes of Health (NIH) grant opportunity.
What is the purpose of PAR 18-877?
The purpose is to support early clinical testing of interventions intended to prevent, slow, or improve cognitive decline related to aging and Alzheimers disease. The FOA is designed to move promising concepts into structured human testing and to accelerate development of approaches that could affect cognition, function, or disease progression.
What types of studies does this FOA focus on?
The FOA focuses on early stage clinical trials, specifically Phase I and Phase II studies. It also welcomes projects that strengthen the design and execution of early stage clinical trials in this area.
Is a clinical trial required to apply?
No. The mechanism is labeled "Clinical Trial Optional," which means applicants may propose a clinical trial, but a clinical trial is not strictly required under this listing.
What grant mechanism is used for this opportunity?
The funding mechanism is the NIH R01 grant.
What interventions can be tested under this FOA?
The FOA supports both drug-based (pharmacological) and non-drug (non-pharmacological) approaches. Examples mentioned at a high level include therapeutics, devices, behavioral interventions, lifestyle approaches, cognitive training, care delivery strategies, or other clinically testable methods, as long as they fit an early stage clinical evaluation or meaningfully improve how such trials are conducted.
What conditions or populations does this FOA target?
The FOA targets age-related cognitive decline and the full spectrum (continuum) of Alzheimers disease, from pre-symptomatic or preclinical stages through mild and more advanced stages.
Does the FOA allow studies in preclinical or pre-symptomatic Alzheimers disease?
Yes. The scope explicitly includes pre-symptomatic or preclinical stages, where biological changes may be present even if daily function is largely intact.
Does the FOA also support studies in later stages of Alzheimers disease?
Yes. The scope includes mild and more advanced stages, supporting trials that may be symptom- or function-oriented in later disease phases.
What is meant by "the spectrum of Alzheimers disease" in this FOA?
It refers to coverage across the Alzheimers continuum, ranging from early biological or preclinical changes through progressively symptomatic stages, so interventions can be tested at the stage where they may be most effective.
Beyond testing interventions, what else does the FOA encourage?
The FOA welcomes applications that improve the science of clinical trials in this space. This includes work on better outcome measures, stronger recruitment and retention approaches, improved statistical or operational methods, and strategies to make early stage trials more informative and efficient.
What outcomes is the program trying to influence?
The program aims to support approaches that could meaningfully affect cognition, function, or disease progression, and to improve the quality and interpretability of early human studies.
Why does the FOA emphasize improvements in trial design and methodology?
The intent is to raise the quality and interpretability of early stage studies so that later, larger confirmatory trials can be better justified and better designed.
What kinds of trial design improvements are within scope?
Examples described include improved outcome measures, enhanced recruitment and retention strategies, stronger statistical methods, better operational methods, and other strategies that increase efficiency and informativeness of Phase I/II trials in Alzheimers disease and age-related cognitive decline.
What type of funding instrument is this?
The instrument type is a discretionary grant.
What is the activity category for this opportunity?
The activity category is listed under Education and Health.
What CFDA numbers are associated with this opportunity?
The associated CFDA numbers are 93.361 and 93.866, corresponding to NIH programs related to aging and neurological disorders.
When was this opportunity created?
The opportunity was created on 2018-07-26.
What is the original closing date listed for this opportunity?
The original closing date provided is 2022-01-07.
Is the award ceiling listed in the provided information?
No. The provided source data does not specify an award ceiling.
Is the expected number of awards listed?
No. The provided source data does not specify the expected number of awards.
Who is eligible to apply?
Eligibility is broad and includes many domestic organizations and governmental entities, as well as non-domestic (foreign) organizations. Eligible applicants listed include various levels of government, educational institutions, tribal entities, nonprofits, for-profits, small businesses, and other named organization types.
Are state, local, or special district governments eligible?
Yes. Eligible applicants include state governments, county governments, city or township governments, special district governments, and independent school districts.
Are colleges and universities eligible?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are eligible.
Are tribal governments or tribal organizations eligible?
Yes. Eligibility includes federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized.
Are nonprofits eligible, and do they need 501(c)(3) status?
Nonprofits are eligible both with and without 501(c)(3) status (outside institutions of higher education), according to the provided information.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among eligible applicants.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The eligibility list explicitly includes non-domestic (non-U.S.) entities (foreign organizations).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are included among the other eligible applicants highlighted by NIH in the provided information.
Are minority-serving institutions specifically included?
Yes. The provided information highlights eligibility for 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); and other diverse institution types.
What does a competitive application generally need to include (based on the description provided)?
Based on the description, a competitive application would propose either (1) a credible early stage (Phase I/II) clinical trial plan or (2) a strong trial-methods project relevant to Alzheimers disease and age-related cognitive decline. Key considerations include clearly defining the participant population and disease stage, presenting a rationale for the intervention, addressing feasibility, including safety monitoring appropriate for Phase I/II work, and selecting outcome measures that can show whether the approach is promising for larger-scale testing.
What stage of clinical development is this FOA intended to support?
It is intended to support early human testing, specifically Phase I and Phase II clinical studies, to help determine whether an intervention is promising enough for later confirmatory trials.
Does the FOA support prevention-oriented trials?
Yes. Because the FOA includes preclinical and early stages of Alzheimers disease and age-related cognitive decline, it supports prevention-oriented work in earlier stages as well as other objectives in later stages.
Does the FOA support symptom- or function-oriented trials?
Yes. The description notes that the wide scope supports symptom- or function-oriented approaches, particularly in later stages of disease.
What is the overall goal of the program?
The overall goal is to accelerate the development of interventions (pharmacological and non-pharmacological) and to improve early stage trial design and execution so that larger, confirmatory trials can be better justified and better designed.
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