Opportunity Information: Apply for PAR 21 157
The funding opportunity titled "The Midlife in the United States Study - Cognitive and Neurocognitive Precursors of AD/ADRD (U01 Clinical Trial Not Allowed)" (PAR-21-157) is a National Institutes of Health (NIH) cooperative agreement designed to expand and deepen Alzheimer’s disease (AD) and Alzheimer’s disease related dementias (AD/ADRD) research by leveraging a major ongoing national study: the Midlife in the United States Study (MIDUS). The central idea is to support an AD/ADRD-focused U01 project that is not a standalone effort, but an ancillary project that is tightly integrated with the larger MIDUS U19 program. In practical terms, the award is meant to add targeted, in-depth cognitive and neurocognitive measures (and related behavioral, social, psychological, and biological data) to help clarify how risk and resilience for cognitive decline and AD/ADRD develop across adulthood, particularly from midlife onward.
The scientific purpose is explicitly centered on identifying and explaining pathways that connect lived experience and biology to later-life brain health outcomes. The FOA emphasizes the need to elucidate behavioral, social, psychological, and biological mechanisms that may either increase vulnerability to cognitive decline or protect against it. Because MIDUS already tracks participants across time and collects rich multidimensional data, an integrated ancillary U01 can take advantage of existing longitudinal information to test more precise hypotheses about early or midlife precursors of impairment, the timing of changes, and the ways multiple domains (for example, stress exposures, socioeconomic conditions, mental health, health behaviors, and physiological markers) interact to shape trajectories leading toward or away from AD/ADRD.
This opportunity uses the cooperative agreement mechanism (U01), which generally means the NIH expects an active partnership with awardees rather than a hands-off relationship. Applicants should anticipate substantial coordination requirements, data harmonization needs, and close alignment with MIDUS infrastructure, schedules, and scientific priorities. The FOA also states "Clinical Trial Not Allowed," signaling that the proposed work should not be framed as an NIH-defined clinical trial (for example, assigning participants to interventions to evaluate effects on health-related outcomes). Instead, the focus is on observational, mechanistic, and measurement-driven research that complements MIDUS rather than introducing interventional trial components.
Eligibility is broad across U.S.-based institutions and organizations. Eligible applicants include state, county, city/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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant types 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, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by NIH policy) are not allowed.
Administratively, the opportunity falls under the NIH health research activity category and is associated with CFDA number 93.866. The posted original closing date was February 1, 2022, and the FOA record indicates a creation date of February 26, 2021. While the summary information provided does not specify an award ceiling or the expected number of awards, the overall structure implies a targeted, integrated project intended to add specialized AD/ADRD-relevant cognitive and neurocognitive depth to the MIDUS platform rather than funding a large number of unrelated projects.
In short, this FOA supports a U.S.-based research team to build an AD/ADRD-focused ancillary study that plugs into MIDUS, with the goal of uncovering earlier-life and midlife markers and mechanisms of cognitive decline and dementia risk, while also identifying factors that promote resilience. The emphasis is on integration, longitudinal insight, and multi-level pathways spanning behavior, social context, psychology, and biology, without proposing an NIH-defined clinical trial.Apply for PAR 21 157
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "The Midlife in the United States Study - Cognitive and Neurocognitive Precursors of AD/ADRD (U01 Clinical Trial Not Allowed)" 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 2021-02-26.
- Applicants must submit their applications by 2022-02-01. (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 title and identifier of this funding opportunity?
The opportunity is titled "The Midlife in the United States Study - Cognitive and Neurocognitive Precursors of AD/ADRD (U01 Clinical Trial Not Allowed)" and the FOA number is PAR-21-157.
Which agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity.
What type of award mechanism is being used?
The FOA uses a cooperative agreement mechanism (U01). This generally indicates a more active partnership with NIH compared with a standard grant, including coordination and alignment expectations.
What does a U01 cooperative agreement imply for how the project will be run?
Because this is a cooperative agreement, applicants should expect substantial coordination requirements and an active relationship with NIH. The FOA also signals the need for close alignment with MIDUS infrastructure, schedules, and scientific priorities, as well as potential data harmonization work.
What is the main goal of this FOA?
The goal is to expand and deepen Alzheimer’s disease (AD) and Alzheimer’s disease related dementias (AD/ADRD) research by leveraging the Midlife in the United States Study (MIDUS). The funded project is intended to add targeted, in-depth cognitive and neurocognitive measures (and related behavioral, social, psychological, and biological data) to clarify how risk and resilience for cognitive decline and AD/ADRD develop across adulthood, particularly from midlife onward.
What is MIDUS, and how is it used in this opportunity?
MIDUS is described as a major ongoing national study that tracks participants across time and collects rich, multidimensional data. This FOA is designed to fund an ancillary U01 project that plugs into and leverages MIDUS, rather than operating as a separate, standalone study.
Is this funding for a standalone Alzheimer’s study?
No. The FOA is explicitly framed as supporting an AD/ADRD-focused U01 project that is an ancillary project tightly integrated with the larger MIDUS U19 program, not a standalone effort.
What does "ancillary project" mean in the context of this FOA?
Based on the FOA description, an ancillary project is meant to complement and integrate with MIDUS by adding specialized AD/ADRD-relevant measures and analyses, while taking advantage of MIDUS’s existing longitudinal design and data resources.
What scientific topics and pathways does NIH want to understand through this project?
The FOA emphasizes identifying and explaining pathways connecting lived experience and biology to later-life brain health outcomes. It calls for elucidating behavioral, social, psychological, and biological mechanisms that may increase vulnerability to cognitive decline or protect against it.
What kinds of data or measures are encouraged?
The opportunity highlights the addition of targeted, in-depth cognitive and neurocognitive measures, along with related behavioral, social, psychological, and biological data, to strengthen understanding of AD/ADRD risk and resilience across adulthood.
What populations or life stages are emphasized?
The focus is on how risk and resilience develop across adulthood, with particular emphasis on midlife onward and earlier-life or midlife precursors of later cognitive impairment and AD/ADRD.
What research approach is emphasized: observational or interventional?
The FOA emphasizes observational, mechanistic, and measurement-driven research that complements MIDUS. It is not intended to introduce intervention-based trial components.
What does "Clinical Trial Not Allowed" mean here?
The FOA states "Clinical Trial Not Allowed," meaning the proposed work should not be framed as an NIH-defined clinical trial. The provided description gives an example of what should be avoided: assigning participants to interventions to evaluate effects on health-related outcomes.
Can an application include assigning participants to an intervention?
No. The FOA indicates that NIH-defined clinical trials are not allowed, including studies that assign participants to interventions to evaluate effects on health-related outcomes.
Why is MIDUS a good platform for this type of AD/ADRD work?
Because MIDUS already tracks participants across time and collects rich multidimensional data, an integrated ancillary project can use existing longitudinal information to test hypotheses about early or midlife precursors, timing of changes, and interactions across domains such as stress, socioeconomic conditions, mental health, health behaviors, and physiological markers.
What kinds of interactions among factors does the FOA highlight?
The FOA description points to multi-domain interactions, including (as examples) stress exposures, socioeconomic conditions, mental health, health behaviors, and physiological markers, and how these may shape trajectories toward or away from AD/ADRD.
Who is eligible to apply?
Eligibility is broad across U.S.-based institutions and organizations. Eligible applicants include various government entities (state, county, city/township, special district), 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/Indian housing authorities, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, and small businesses.
Are specific types of institutions called out as eligible?
Yes. The FOA highlights additional eligible types 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, and U.S. territories or possessions.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization apply if it has a non-U.S. component involved in the project?
No. The FOA states that non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
What NIH activity category is associated with this opportunity?
The FOA falls under the NIH health research activity category.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.866.
What are the key dates mentioned in the FOA summary?
The FOA record indicates a creation date of February 26, 2021, and the posted original closing date was February 1, 2022.
Does the provided information specify an award ceiling or the expected number of awards?
No. The summary information provided does not specify an award ceiling or the expected number of awards.
Is the intent to fund many unrelated projects?
No. Based on the description, the structure implies a targeted, integrated project intended to add specialized AD/ADRD-relevant cognitive and neurocognitive depth to the MIDUS platform, rather than funding a large number of unrelated projects.
What is the overall "in plain terms" summary of what NIH is trying to fund?
NIH is seeking a U.S.-based research team to build an AD/ADRD-focused ancillary study that integrates with MIDUS, adds in-depth cognitive and neurocognitive measures and related multi-level data, and uses MIDUS’s longitudinal strengths to uncover early and midlife markers and mechanisms of later cognitive decline and dementia risk, including factors tied to resilience, without proposing an NIH-defined clinical trial.
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