Peripheral Pathology in the Lewy Body Dementias (R01 Clinical Trial Not Allowed) | RFA NS 20 014

Opportunity Information: Apply for RFA NS 20 014

Peripheral Pathology in the Lewy Body Dementias (R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) research grant opportunity focused on improving how Lewy body dementias are detected and understood by looking beyond the usual sources of biomarkers. Instead of concentrating on blood or cerebrospinal fluid (CSF), the program emphasizes peripheral, non-blood and non-CSF specimens and tissues where disease-related changes may show up earlier. The central scientific premise is that abnormal alpha-synuclein accumulation, a hallmark feature associated with Lewy body disorders, may occur in peripheral sites before clear neurological symptoms emerge. If that is true, peripheral tissues could offer practical paths to earlier diagnosis, better disease tracking, and eventually support the development of more targeted treatments.

The initiative encourages projects that identify, measure, and validate potential biomarkers specifically in peripheral tissues relevant to Lewy body dementias. Examples of target specimens include tissues from the autonomic nervous system, skin, salivary glands, the gastrointestinal tract and related microbiome samples, and olfactory mucosa. These sample types are highlighted because they align with known or suspected routes of pathology and symptom development in Lewy body conditions, such as autonomic dysfunction, gastrointestinal issues, and impaired sense of smell. The opportunity is essentially trying to broaden the biomarker search into body systems where alpha-synuclein pathology may be detectable pre-symptomatically, which could open the door to identifying people at risk earlier than current clinical methods allow.

This is an R01 mechanism, meaning it supports hypothesis-driven, investigator-initiated research projects that typically involve substantial, multi-year research plans. The notice explicitly states "Clinical Trial Not Allowed," which signals that applicants should not propose a clinical trial as defined by NIH (for example, prospective assignment of human participants to an intervention to evaluate health-related outcomes). The work can still involve human samples and observational or specimen-based research, but it must remain within the boundaries of non-trial research as required by the funding announcement.

The funding opportunity is listed as discretionary and uses a grant funding instrument, with a health-related activity category. It is associated with CFDA numbers 93.853 and 93.866, reflecting NIH neuroscience and neurology-related program areas. The opportunity number is RFA-NS-20-014, and the sponsoring agency is NIH. The original closing date shown is December 3, 2019, and the creation date is September 5, 2019, which is important context for anyone trying to locate the announcement historically or determine whether a related reissue or successor funding opportunity exists.

Eligibility is broad and includes many types of U.S. organizations and governmental units, along with certain international entities. 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 and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also specifically calls out additional eligible applicant categories, 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). In practical terms, NIH is signaling a desire for broad participation across institutional types, including organizations that serve underrepresented populations and entities outside the United States where relevant expertise or samples may exist.

Overall, the opportunity is aimed at accelerating biomarker discovery for Lewy body dementias by leveraging peripheral pathology and peripheral specimens, based on the idea that disease-related alpha-synuclein changes may be detectable outside the central nervous system earlier than traditional approaches can capture. The hoped-for outcome is a stronger pipeline of candidate biomarkers that could improve early identification, support better differentiation of Lewy body dementias from related disorders, and provide measurable biological signals that help move future therapeutic development forward, even though the projects funded under this specific announcement are not meant to be clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Peripheral Pathology in the Lewy Body Dementias (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 2019-09-05.
• Applicants must submit their applications by 2019-12-03. (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 20 014

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