Biomarkers for the Lewy Body Dementias (U01 Clinical Trial Not Allowed) | RFA NS 22 001

Opportunity Information: Apply for RFA NS 22 001

Biomarkers for the Lewy Body Dementias (U01 Clinical Trial Not Allowed) is an NIH funding opportunity (RFA-NS-22-001) designed to push forward hypothesis-driven clinical research that can identify new biomarkers for Lewy Body Dementias (LBD). The emphasis is on biomarkers that can improve how LBD is detected, how its course is predicted, and how treatment response or therapeutic target engagement might be measured. In practical terms, the FOA is looking for well-justified clinical studies in real LBD patient populations that can deliver measurable, shareable biomarker outputs with clear diagnostic, prognostic, and/or therapeutic relevance.

A central requirement is that all biomarker work must be performed in patients with LBD and must align with the Parkinson's Disease Biomarker Program (PDBP) infrastructure. This means applicants have to follow PDBP protocols for clinical assessments and for biospecimen collection, handling, and related procedures. The point of that requirement is standardization: by using common protocols, datasets and biospecimens become more comparable across projects and more valuable for downstream validation. Alongside that, the FOA makes data and resource sharing a core expectation. Results, source data, and biospecimens are expected to be broadly shareable through PDBP repositories, reinforcing that these projects should contribute to community-wide resources rather than remain siloed within individual labs or institutions.

The award mechanism is a U01 cooperative agreement, which typically indicates substantial NIH programmatic involvement during the project compared with a standard research grant. While the FOA supports clinical research, it explicitly states "Clinical Trial Not Allowed," signaling that proposed activities should not be interventional clinical trials. Instead, the scope generally fits observational, hypothesis-driven clinical studies aimed at biomarker discovery and characterization, conducted with rigorous clinical phenotyping and standardized sample collection. The overall activity category is health-related research, and the listed CFDA numbers are 93.853 and 93.866.

Eligibility is broad and includes many types of U.S.-based organizations and governments. 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 and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible groups 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.

Foreign eligibility is limited in a way that is typical for many NIH opportunities. Non-domestic (non-U.S.) entities or foreign institutions are not eligible to apply directly, and non-domestic components of U.S. organizations are also not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain well-justified elements of the project that take place outside the U.S. if they meet NIH policy requirements and are appropriately documented and approved.

The opportunity was created on August 6, 2021, with an original closing date of November 22, 2021. The listing does not provide an award ceiling or expected number of awards in the provided source text, so applicants would normally look to the full FOA for budget guidance, project period limits, and specific review criteria. Overall, the program is best understood as an effort to accelerate credible LBD biomarker discovery by requiring strong clinical hypotheses, standardized PDBP-aligned methods, and meaningful sharing of data and biospecimens so that findings can be validated and reused by the broader research community.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Biomarkers for the Lewy Body Dementias (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 2021-08-06.
• Applicants must submit their applications by 2021-11-22. (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 RFA NS 22 001

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