Assessment of TBI-related ADRD Pathology Related to Cognitive Impairment and Dementia Outcomes (U01 - Clinical Trial Not Allowed) | RFA NS 24 003

Opportunity Information: Apply for RFA NS 24 003

This funding opportunity, RFA NS 24 003, is an NIH cooperative agreement (U01) that supports a coordinated, multisite research effort to better understand how traumatic brain injury (TBI) is linked to Alzheimer’s disease and related dementias (ADRD) pathology and to real-world outcomes like cognitive impairment and dementia. The central aim is to comprehensively characterize ADRD-relevant neuropathology in people with a history of TBI and to connect what is found in the brain after death (neuropathological burden) with what was observed clinically during life (antemortem symptoms and clinical presentation). While the research is clinical in its relevance, the NOFO is explicitly labeled “Clinical Trial Not Allowed,” meaning applicants should not propose prospective interventional trials.

The studies funded under this NOFO are expected to dig into why outcomes differ across individuals by explicitly examining both personal and injury-related factors. On the individual side, NIH is looking for analyses that consider variables such as sex, age at the time of injury, time since injury, and social determinants of health, among other potentially important modifiers. On the injury side, the NOFO emphasizes characterizing injury severity and injury frequency, recognizing that a single severe TBI and multiple repetitive TBIs may have different biological signatures and long-term consequences. The overarching expectation is that investigators will clarify how these factors influence the type and extent of ADRD-related pathology, and how that pathology corresponds to cognitive and dementia outcomes.

A major scientific deliverable is improved clarity on the prevalence and patterns of TBI-associated neurodegenerative diagnoses within participating brain banks. This includes documenting the prevalence of TBI-related ADRD diagnoses and evaluating chronic traumatic encephalopathy (CTE) pathology, which is particularly relevant in the context of repetitive head impacts. The NOFO encourages a brain-bank-centered approach that can compare and harmonize findings across sites, strengthening the field’s ability to distinguish which neuropathological features are most strongly associated with TBI history and which are more consistent with non-TBI pathways to dementia.

From a design and resource standpoint, NIH signals strong interest in applications that combine retrospective resources with forward-looking sample acquisition. Competitive projects are expected to leverage existing retrospective samples (for example, previously collected brain tissue and associated records), while also including plans to acquire new brain tissue specimens to build the resource and fill gaps in representation, exposure history, and clinical characterization. Importantly, applicants are expected to incorporate methods for assessing antemortem symptomatology and clinical presentation, so that brain findings are not interpreted in isolation but are linked to documented cognitive trajectories, neuropsychiatric features, and dementia-related outcomes observed during life.

Data sharing is positioned as a make-or-break element rather than a minor administrative requirement. The NOFO highlights broad sharing of clinical and neuropathological data as a critical feature of successful applications. Beyond standard dataset sharing, the announcement specifically calls for development of a digital resource intended to support distribution and sharing of assessed neuropathological tissue, suggesting an emphasis on creating scalable infrastructure that allows the wider research community to discover, access, and reuse harmonized information and potentially tissue-related outputs (for example, digitized pathology, standardized neuropathology assessments, or other shareable derivatives). In practical terms, this points toward expectations around common data elements, cross-site harmonization, and governance processes that enable responsible sharing while protecting privacy and maintaining scientific rigor.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities, such as state, county, and local governments; special districts; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The NOFO also explicitly highlights additional eligible applicant categories, including 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), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, but foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain eligible foreign collaborations when justified and compliant with NIH policy.

Administratively, the opportunity is listed under CFDA numbers 93.853 and 93.866, with an award ceiling of $1,300,000. The original closing date shown is 2023-07-28. As a U01 cooperative agreement, awardees should expect substantial NIH programmatic involvement compared with a standard research project grant, typically including coordination expectations, milestone-driven progress, and collaboration requirements consistent with a multisite effort and shared-resource goals.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Assessment of TBI-related ADRD Pathology Related to Cognitive Impairment and Dementia Outcomes (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): 93.853, 93.866.
• This funding opportunity was created on 2023-05-19.
• Applicants must submit their applications by 2023-07-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,300,000.00 in funding.
• 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 RFA NS 24 003

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