Development and Validation of Advanced Mammalian Models for Alzheimers Disease-Related Dementias (ADRD) (R61/R33 Clinical Trial Not Allowed) | PAR 19 167

Opportunity Information: Apply for PAR 19 167

The National Institutes of Health (NIH) funding opportunity titled "Development and Validation of Advanced Mammalian Models for Alzheimers Disease-Related Dementias (ADRD) (R61/R33 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR 19-167) supports research aimed at building better mammalian models of dementias that are related to, overlap with, or are often grouped alongside Alzheimers disease. The central focus is on creating innovative animal models that more faithfully mirror what happens in people, not just at a single molecular pathway or a narrow time window, but across the biological and behavioral spectrum of disease. The FOA specifically calls out Lewy body dementia (LBD), vascular contributions to cognitive impairment and dementia (VCID), frontotemporal degeneration (FTD), and mixed etiology dementias (MED), reflecting a recognition that real-world dementia is frequently complex and multi-factorial rather than driven by one pathology alone.

The opportunity emphasizes that proposed models should recapitulate multiple dimensions of human disease, including molecular and cellular changes, neuropathology, and measurable impacts on behavior and cognition. A key expectation is that models show features consistent with how these disorders unfold in humans, particularly a mid- to late-life onset rather than early-onset phenotypes that can be convenient experimentally but may poorly match typical clinical disease trajectories. Applicants are encouraged to produce models that show multiple, age-dependent neuropathological processes and the corresponding functional abnormalities, such as cognitive decline, behavioral changes, and physiological impairments tied to the underlying brain pathology. In other words, the goal is not just to generate an animal with a single hallmark lesion, but to build a model that develops a more complete disease profile over time, closer to the progressive nature of ADRD in humans.

Another major theme is thorough characterization and validation. For each mammalian model developed, investigators are expected to define a relevant suite of phenotypes that can inform human disease mechanisms and progression. This includes tracking outcomes across the full lifespan when feasible, or, for longer-lived mammalian species, across the stages of adulthood most relevant to disease emergence and progression. The FOA is pushing for models that are not only created but also deeply profiled, so the field can use them as reliable tools to test hypotheses about disease biology, understand interacting pathologies (for example, vascular injury plus protein aggregation), and identify therapeutic targets. Importantly, the announcement specifies "Clinical Trial Not Allowed," clarifying that the supported work is preclinical and model-focused rather than interventional studies in humans.

The mechanism is an R61/R33 phased innovation award, which generally signals a milestone-driven pathway where early-stage development work transitions into a second phase focused on expanded validation and application once predefined criteria are met. In practical terms, this structure is designed to support higher-risk model development while still insisting on clear go/no-go benchmarks that demonstrate the model is achieving the intended disease-relevant features and is robust enough to serve as a community resource for mechanistic and translational research.

Eligibility is broad and includes many types of domestic applicants such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments and organizations; public housing authorities/Indian housing authorities; and nonprofit and for-profit organizations (including small businesses). The FOA also explicitly welcomes a wide range of other eligible applicants, 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, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations. This reflects an intent to widen participation and enable contributions from diverse research environments.

Administrative details included in the source information identify the NIH as the agency, the opportunity category as discretionary, and the funding instrument as a grant under the health activity category. The CFDA numbers listed (93.233, 93.837, 93.838, 93.839, 93.853, 93.866) indicate alignment with multiple NIH program areas relevant to neurological disorders and aging-related research. The original closing date shown is March 14, 2019, and the creation date is January 23, 2019, which anchors this as a specific historical solicitation cycle. The award ceiling and expected number of awards are not specified in the provided excerpt.

Overall, this FOA is about raising the bar for ADRD animal models by encouraging the development of mammalian systems that are multi-dimensional, age-appropriate in onset and progression, and validated with a comprehensive set of disease-relevant phenotypes. The practical payoff NIH is aiming for is a set of advanced, rigorously characterized models that the research community can use to dissect disease mechanisms, understand how different pathologies interact over time, and improve the credibility and usefulness of preclinical testing aimed at identifying and prioritizing therapeutic targets for ADRD.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and Validation of Advanced Mammalian Models for Alzheimers Disease-Related Dementias (ADRD) (R61/R33 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): 93.233, 93.837, 93.838, 93.839, 93.853, 93.866.
• This funding opportunity was created on 2019-01-23.
• Applicants must submit their applications by 2019-03-14. (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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