Development and Characterization of Experimental models of post-TBI ADRD (R01 - Clinical Trial Not Allowed) | PAR 23 218

Opportunity Information: Apply for PAR 23 218

The NIH funding opportunity PAR 23-218, titled "Development and Characterization of Experimental Models of post-TBI ADRD (R01 - Clinical Trial Not Allowed)," supports research projects aimed at building and validating experimental models that mirror what happens in people who develop Alzheimer’s disease or related dementias (AD/ADRD) after a traumatic brain injury (TBI). The central purpose is to create models that faithfully reproduce the key neuropathological signatures seen in human post-TBI neurodegeneration, along with clinically relevant downstream outcomes, including neurodegenerative changes, biochemical alterations, and measurable behavioral sequelae. In other words, the program is trying to close the gap between what researchers can model in the lab and what clinicians actually see in patients over time after TBI, so that future therapeutic and mechanistic studies rest on models that are more predictive and more reproducible.

A defining feature of this FOA is that it requires a team-science, consortium-style structure rather than a single-lab approach. Applications are expected to involve multiple sites, typically in the range of three to five, that will develop and/or test specific experimental models and then carry out a coordinated reproducibility effort across the consortium. This emphasis on cross-site reproducibility is a major expectation of the program, reflecting a broader concern in preclinical neuroscience about whether findings and model behaviors hold up when protocols are implemented by different groups in different settings. The intent is not just to produce a novel model, but to demonstrate that it can be implemented consistently with shared standards and that it yields comparable outcomes across independent teams.

The FOA also sets clear expectations for the expertise represented on the research team. Each application must include a clinician with expertise in post-TBI AD/ADRD, ensuring that model development and outcome selection remain anchored to clinical reality and the complexities of patient presentation. In addition, applicants are encouraged to include neuropathologists as consultants, which signals the importance of rigorous pathological validation and alignment of model-derived brain changes with human neuropathology. Together, these requirements are meant to ensure that proposed models are not only technically sophisticated but also clinically interpretable and neuropathologically grounded.

Another key requirement is a strong commitment to sharing. Models generated through this funding opportunity must be shared, along with detailed model information and any related standards, with the VA-funded interagency preclinical resource center known as PRECISE TBI. This component is designed to make the resulting models broadly usable and to accelerate progress by enabling other researchers to adopt standardized methods rather than reinventing them. The sharing expectation extends beyond a general statement of openness; it is built into the program as an explicit requirement, so applicants should be prepared to provide clear plans for documentation, standard operating procedures, and any quality-control benchmarks needed for other groups to successfully implement the model.

In terms of scientific priorities, the FOA explicitly encourages projects that investigate neurodegeneration of white matter and chronic inflammation in the context of post-TBI AD/ADRD. These areas reflect growing evidence that long-term post-injury changes in white-matter integrity and persistent neuroinflammatory processes may be central drivers of later-life neurodegenerative trajectories. The FOA also emphasizes innovation and strongly encourages applicants to go beyond existing AD/ADRD models. This suggests a preference for approaches that capture TBI-specific mechanisms and trajectories rather than simply layering TBI features onto traditional Alzheimer’s models without demonstrating that the combined model better reflects post-TBI disease biology.

Administratively, this is an NIH R01 grant mechanism and is designated "Clinical Trial Not Allowed," meaning the supported work should be preclinical or otherwise non-clinical-trial research. The funding opportunity is categorized as discretionary and falls under the health funding activity category, with CFDA numbers 93.853 and 93.866. The agency is the National Institutes of Health. The opportunity originally listed a closing date of 2023-09-22, and it included an award ceiling of $670,000. The source information also lists "ExpectedAwards:" but does not provide a number, implying that award count may vary depending on available funds and application quality.

Eligibility is broad and includes many common U.S.-based applicant types, such as state, county, city, and special district governments; public and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; federally recognized Native American tribal governments and other Native American tribal organizations; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other categories. The FOA also highlights additional eligible applicant groups, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it draws firm lines around foreign participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed, which generally means discrete project elements may be performed outside the U.S. under specific NIH rules and with strong justification, even though the applicant organization itself must be domestic.

Taken together, this FOA is pushing the field toward experimental post-TBI AD/ADRD models that are clinically anchored, neuropathologically validated, and proven reproducible across multiple independent sites, with an explicit expectation that the resulting models and standards will be shared through PRECISE TBI to strengthen the broader research ecosystem.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and Characterization of Experimental models of post-TBI ADRD (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 2023-06-14.
• Applicants must submit their applications by 2023-09-22. (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 $670,000.00 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 PAR 23 218

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