Clinical and Biological Measures of TBI-related Dementia Including Chronic Traumatic Encephalopathy (R01 Clinical Trial Not Allowed) | PAR 22 024

Opportunity Information: Apply for PAR 22 024

The National Institutes of Health (NIH) funding opportunity PAR-22-024, titled "Clinical and Biological Measures of TBI-related Dementia Including Chronic Traumatic Encephalopathy (R01 Clinical Trial Not Allowed)," supports research aimed at understanding why some people with a history of traumatic brain injury (TBI) experience long-term but relatively stable cognitive problems, while others go on to develop progressive neurodegeneration that looks more like a dementia process. A central focus is on TBI-related neurocognitive decline that raises risk for dementia and for traumatic encephalopathy syndrome (TES), which is the clinical, symptom-based diagnostic counterpart to the neuropathological diagnosis of chronic traumatic encephalopathy (CTE). The program is designed to sharpen clinical characterization and uncover biological mechanisms that help distinguish static chronic impairment after TBI from progressive disease trajectories associated with TES and dementia.

Projects are expected to build on existing, well-characterized cohorts of individuals with prior TBI, especially populations already enriched for higher risk of cognitive impairment or dementia and that can continue to be followed over time. The idea is to leverage cohorts where there is already substantial background information (for example, injury history, clinical evaluations, or prior imaging) and then extend them longitudinally to track change. While the emphasis is on established populations, the FOA allows recruitment of additional participants when appropriate, particularly if it strengthens the ability to study progression, identify subgroups, or improve statistical power and representation.

The scientific scope centers on identifying and validating clinical and biological measures of progressive neurodegeneration after TBI. This includes clinical measures (such as neuropsychological profiles and symptom patterns relevant to TES), neuroimaging measures, physiological measures, and biospecimen-based measures (for example, blood or other biofluids). The overarching goal is to advance understanding of underlying pathophysiology and improve the clinical characterization of chronic post-TBI outcomes, including markers that can signal risk, stage disease, or differentiate types of long-term impairment. By targeting measures that can be tracked over time, the FOA is aligned with research that can clarify trajectories of decline, heterogeneity among TBI survivors, and links between measurable biological changes and real-world clinical outcomes.

A defining requirement of this opportunity is broad data and resource sharing. Awardees are expected to share clinical data, neuroimaging data, physiological data, and biospecimen-related information widely, and to help create a dataset and associated biofluid resource that the broader research community can use. This emphasis reflects the need for larger, harmonized resources in TBI-related dementia and TES research, where progress often depends on combining information across studies, comparing results across cohorts, and enabling secondary analyses and replication. In practice, applicants should anticipate planning for standardized data collection where feasible, clear documentation and curation, and infrastructure for depositing and distributing data and biospecimens in a way that is useful beyond the original study team.

The funding mechanism is an NIH R01 research project grant, and the FOA explicitly states that clinical trials are not allowed under this announcement. It falls under NIH health-related research activities (CFDA numbers 93.853 and 93.866). The opportunity category is discretionary, and the funding instrument type is a grant. The listed award ceiling is $1,000,000, indicating an upper bound on expected funding levels per award as described in the source summary. The original closing date provided is 2021-11-10, and the FOA creation date is 2021-08-10.

Eligibility is broad and includes many common applicant types: state, county, and local governments; 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 (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, non-U.S. (foreign) organizations, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions. This breadth signals an interest in encouraging diverse institutional participation and potentially improving inclusion of varied populations affected by TBI.

In practical terms, a competitive application under this FOA would typically propose a longitudinal research plan anchored in an existing TBI cohort, specify which clinical and biological measures will be collected and why they are suited to separating static impairment from progressive neurodegeneration, and show how those measures relate to TES and dementia risk. It would also spell out a robust sharing plan for data, imaging, and biospecimens, since the creation of a community resource is not a side benefit here but a core feature of what NIH is trying to achieve with this announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical and Biological Measures of TBI-related Dementia Including Chronic Traumatic Encephalopathy (R01 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 2021-08-10.
• Applicants must submit their applications by 2021-11-10. (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 $1,000,000.00 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.

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