The Midlife in the United States Study - Cognitive and Neurocognitive Precursors of AD/ADRD (U01 Clinical Trial Not Allowed) | PAR 21 157

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.

• 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.

Apply for PAR 21 157

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