Opportunity Information: Apply for PAR 16 365
Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01) (Funding Opportunity Number PAR 16 365) is a National Institutes of Health (NIH) discretionary grant opportunity designed to move promising interventions into early-stage human testing for cognitive aging and Alzheimers disease. The main purpose of the announcement is to support the development and conduct of Phase I or Phase II clinical trials that evaluate both pharmacological approaches (such as drugs or biologics) and non-pharmacological approaches (such as behavioral, lifestyle, cognitive, device-based, or other non-drug strategies). A key emphasis is on covering the full disease and risk spectrum, meaning studies may focus on people with age-related cognitive decline as well as individuals with Alzheimers disease ranging from pre-symptomatic stages through more advanced clinical stages. In addition to funding actual pilot trials, the announcement also aims to stimulate research that improves how these trials are designed and run, encouraging innovations that strengthen trial methodology, efficiency, and overall interpretability.
The scope is intentionally broad in terms of who can be studied and what can be tested, as long as the proposed work fits within early-phase clinical trial goals and addresses cognitive decline or Alzheimers disease. Projects are expected to be practical and implementation-focused, reflecting the intent to generate the kind of early clinical evidence that can justify larger, later-phase trials or help eliminate ineffective strategies before major resources are invested. Because the FOA explicitly mentions enhancing trial design and methods, applications can also center on improving key aspects of clinical trials in this area, such as recruitment and retention strategies, outcome measurement, biomarkers and staging approaches, adherence monitoring, feasibility testing, and other methodological elements that can increase the quality and success rate of studies across the AD and cognitive decline landscape.
Eligibility is expansive and includes many types of organizations that can credibly conduct or support clinical trial work. Standard eligible applicants listed include state, county, city or township, and 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; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education when categorized that way); for-profit organizations (other than small businesses) as well as small businesses; and other applicant types. The FOA also highlights additional eligible applicant categories that NIH wants to encourage or explicitly include, 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 even non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that effective Alzheimers and cognitive aging research often depends on diverse clinical sites, community partnerships, and access to varied participant populations.
From the funding mechanics side, the opportunity uses the NIH R01 grant mechanism and is categorized as a grant under a discretionary program. The activity area is listed under education and health, and the associated CFDA numbers are 93.361 and 93.866. The opportunity record shows an original closing date of January 24, 2018, with a creation date of October 6, 2015. An award ceiling is not specified in the provided source data, and the number of expected awards is not shown, which often means applicants should rely on the full FOA text and NIH institute/center guidance for budget expectations, allowable costs, and the likely scale of awards.
In practical terms, the FOA is aimed at investigators and organizations ready to translate promising ideas into structured early clinical testing in humans, whether that is testing a new therapy, repurposing an existing one, or evaluating a non-drug intervention that could slow decline, improve cognitive function, delay symptom onset, or otherwise alter clinically meaningful outcomes. It also supports work that makes these trials better, faster, and more reliable, which is particularly important in Alzheimers disease research where long timelines, heterogeneous participants, and complex endpoints can make early-phase studies challenging.Apply for PAR 16 365
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01)" 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 2015-10-06.
- Applicants must submit their applications by 2018-01-24. (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.
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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR 16 365.
Which agency is offering this opportunity?
This is a National Institutes of Health (NIH) discretionary grant opportunity.
What is the main purpose of this FOA?
The main purpose is to move promising interventions into early-stage human testing for cognitive aging, age-related cognitive decline, and Alzheimers disease by supporting the development and conduct of Phase I or Phase II clinical trials.
What type of clinical trials does this FOA support?
This FOA supports Phase I and Phase II clinical trials (pilot/early-stage trials) designed to generate early clinical evidence that can justify later, larger trials or help rule out ineffective approaches before major resources are invested.
What kinds of interventions can be tested under this FOA?
The scope includes both:
- Pharmacological approaches (for example, drugs or biologics)
- Non-pharmacological approaches (for example, behavioral, lifestyle, cognitive, device-based, or other non-drug strategies)
Does the FOA focus only on diagnosed Alzheimers disease?
No. A key emphasis is covering the full disease and risk spectrum. Studies may focus on people with age-related cognitive decline and also individuals with Alzheimers disease ranging from pre-symptomatic stages through more advanced clinical stages.
What populations or stages of disease are within scope?
The FOA is designed to cover a broad range, including:
- Individuals experiencing age-related cognitive decline
- Individuals across the Alzheimers disease spectrum, from pre-symptomatic to advanced clinical stages
Is the scope narrow or broad?
The scope is intentionally broad in terms of who can be studied and what can be tested, as long as the proposed work fits early-phase clinical trial goals and addresses cognitive decline or Alzheimers disease.
Beyond funding trials, what else is the FOA trying to accomplish?
In addition to supporting pilot trials, the FOA aims to stimulate research that improves how these trials are designed and run, encouraging innovations that strengthen trial methodology, efficiency, and interpretability.
Can an application focus on improving clinical trial methods rather than testing a specific intervention?
Yes. Because the FOA explicitly highlights enhancing trial design and methods, applications can center on improving key aspects of clinical trials in this area, including recruitment/retention, outcome measurement, biomarkers and staging, adherence monitoring, feasibility testing, and other methodological elements that increase study quality and success.
What trial design or operational topics are specifically encouraged?
The FOA encourages innovations that can make early-stage AD and cognitive decline trials stronger, including:
- Recruitment and retention strategies
- Outcome measurement improvements
- Biomarkers and staging approaches
- Adherence monitoring
- Feasibility testing
- Other methodological elements that increase quality, efficiency, and interpretability
What is the grant mechanism?
The opportunity uses the NIH R01 grant mechanism.
What is the program type?
It is categorized as a grant under an NIH discretionary program.
What is the activity area for this opportunity?
The activity area is listed under education and health.
What are the CFDA numbers associated with this FOA?
The associated CFDA numbers are 93.361 and 93.866.
Who is eligible to apply?
Eligibility is expansive and includes many organization types that can conduct or support clinical trial work, including government entities, higher education institutions, nonprofits, for-profits, small businesses, tribal entities, and additional categories specifically highlighted by NIH.
Are government entities eligible applicants?
Yes. Eligible government entities include:
- State governments
- County governments
- City or township governments
- Special district governments
Are schools and universities eligible?
Yes. Eligible education-related applicants include:
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
Are tribal governments and tribal organizations eligible?
Yes. The FOA includes:
- Federally recognized Native American tribal governments
- Native American tribal organizations that are not federally recognized tribal governments
Are nonprofits eligible to apply?
Yes. The FOA lists nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when categorized that way) as eligible applicants.
Are for-profit organizations eligible to apply?
Yes. Eligible applicants include for-profit organizations (other than small businesses) as well as small businesses.
Are community-based or faith-based organizations eligible?
Yes. The FOA explicitly includes faith-based or community-based organizations among eligible applicant categories.
Are minority-serving institutions eligible?
Yes. The FOA highlights eligibility for multiple minority-serving institution categories, 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)
Are U.S. territories or possessions eligible?
Yes. The FOA includes U.S. territories or possessions among eligible applicant categories.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA states that non-U.S. entities (foreign organizations) are eligible.
Are federal agencies eligible to apply?
Yes. The FOA includes eligible federal agencies as potential applicants.
Are housing authorities eligible?
Yes. The FOA lists public housing authorities and Indian housing authorities as eligible applicant types.
What does it mean that the FOA covers the full disease and risk spectrum?
It means the FOA is not limited to one point in the disease course. It allows studies of people who may be at risk or experiencing age-related cognitive decline, as well as people with Alzheimers disease at stages ranging from pre-symptomatic to more advanced clinical presentation.
What kinds of outcomes or impacts is the FOA trying to support?
The FOA emphasizes early-stage testing that can produce evidence relevant to interventions that could slow decline, improve cognitive function, delay symptom onset, or otherwise affect clinically meaningful outcomes.
Does the FOA support repurposing existing therapies?
Yes. The FOA is aimed at translating promising ideas into early clinical testing, including testing a new therapy, repurposing an existing one, or evaluating a non-drug intervention.
What is the original closing date shown for this opportunity record?
The opportunity record shows an original closing date of January 24, 2018.
What is the creation date shown for this opportunity record?
The creation date shown is October 6, 2015.
Is there an award ceiling listed?
No. An award ceiling is not specified in the provided source data.
Is the number of expected awards provided?
No. The number of expected awards is not shown in the provided source data.
What should applicants do if budget expectations and allowable costs are not shown in the record?
Because the award ceiling and expected number of awards are not provided in the source data, applicants are typically expected to rely on the full FOA text and relevant NIH institute/center guidance for budget expectations, allowable costs, and the likely scale of awards.
Why does the FOA emphasize methodology and interpretability?
The FOA notes that early-stage Alzheimers and cognitive decline trials can be challenging due to factors like long timelines, heterogeneous participant populations, and complex endpoints. Innovations in design and operations are encouraged to make studies more efficient and results more interpretable and reliable.
What is the overall intent of funding pilot trials in this area?
The intent is to support practical, implementation-focused early clinical studies that generate evidence to inform whether an intervention should advance to larger, later-phase trials, or be deprioritized if early data suggest it is ineffective.
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