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.Apply for RFA NS 20 014
- 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.
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Frequently Asked Questions (FAQs)
What is the Peripheral Pathology in the Lewy Body Dementias funding opportunity?
This opportunity is a National Institutes of Health (NIH) research grant focused on improving detection and understanding of Lewy body dementias by studying biomarkers in peripheral (non-blood, non-CSF) specimens and tissues. The goal is to expand biomarker discovery beyond traditional sources like blood or cerebrospinal fluid (CSF), based on the premise that disease-related changes may appear in peripheral sites earlier.
What is the main scientific premise behind this program?
The central idea is that abnormal alpha-synuclein accumulation (a hallmark feature associated with Lewy body disorders) may occur in peripheral tissues before clear neurological symptoms emerge. If peripheral pathology can be detected pre-symptomatically, it could support earlier diagnosis, better disease monitoring, and eventually the development of more targeted treatments.
What types of research does this RFA encourage?
The initiative encourages projects that identify, measure, and validate potential biomarkers in peripheral tissues relevant to Lewy body dementias. Projects are expected to be hypothesis-driven and aligned with peripheral pathology and peripheral specimen-based biomarker discovery and validation.
What specimen types are emphasized (and why)?
The announcement highlights peripheral, non-blood and non-CSF specimens and tissues where disease-related changes may appear earlier. Example specimen types mentioned include:
- Tissues from the autonomic nervous system
- Skin
- Salivary glands
- Gastrointestinal tract tissues
- Related microbiome samples
- Olfactory mucosa
These are emphasized because they connect to known or suspected routes of pathology and symptom development in Lewy body conditions, including autonomic dysfunction, gastrointestinal issues, and impaired sense of smell.
How is this different from biomarker research focused on blood or CSF?
Rather than focusing on biomarkers in blood or cerebrospinal fluid (CSF), this opportunity prioritizes peripheral tissues and non-blood, non-CSF specimens. The intent is to broaden the biomarker search into body systems where alpha-synuclein pathology may be detectable earlier than central nervous system-focused approaches.
What is the grant mechanism for this opportunity?
The mechanism is an NIH R01, which supports hypothesis-driven, investigator-initiated research projects and typically involves substantial, multi-year research plans.
Are clinical trials allowed under this opportunity?
No. The funding announcement explicitly states "Clinical Trial Not Allowed." Applicants should not propose a clinical trial as defined by NIH, such as prospective assignment of human participants to an intervention to evaluate health-related outcomes.
Can projects include human samples or human-related research?
Yes. The opportunity indicates that work can involve human samples and observational or specimen-based research. However, the project must remain within the boundaries of non-trial research as required by the announcement.
What is the program trying to achieve in the long term?
The program aims to accelerate biomarker discovery for Lewy body dementias by leveraging peripheral pathology and peripheral specimens. The hoped-for outcome is a stronger pipeline of candidate biomarkers that can 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 funded projects under this announcement are not clinical trials).
What is the opportunity number for this announcement?
The opportunity number is RFA-NS-20-014.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding instrument and category does it use?
It uses a grant funding instrument and is listed under a health-related activity category. The opportunity is also described as discretionary.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.853 and 93.866, reflecting NIH neuroscience and neurology-related program areas.
What were the key dates listed for this opportunity?
The creation date shown is September 5, 2019. The original closing date shown is December 3, 2019. These dates are important for locating the announcement historically or determining whether a reissue or successor opportunity exists.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. organizations and governmental units, as well as 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
- Small businesses
- U.S. territories or possessions
- Non-domestic (non-U.S.) entities (foreign organizations)
Are organizations that serve underrepresented populations specifically encouraged or included?
Yes. The announcement 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
Overall, NIH signals interest in broad participation across institutional types, including organizations serving underrepresented populations and entities outside the United States when relevant expertise or samples may exist.
What disease area does this opportunity focus on?
This opportunity focuses on Lewy body dementias and related pathology, with an emphasis on peripheral indicators of disease processes associated with alpha-synuclein.
Why is alpha-synuclein mentioned so prominently?
Alpha-synuclein is described as a hallmark feature associated with Lewy body disorders. The announcement is built around the premise that abnormal alpha-synuclein accumulation may be detectable in peripheral tissues before clear neurological symptoms, making it a key target for peripheral biomarker discovery.
Does this opportunity aim to improve early diagnosis and disease tracking?
Yes. A core motivation is that peripheral tissues could offer practical paths to earlier diagnosis and better disease tracking if disease-related changes appear there before neurological symptoms become clear.
Is the purpose of this RFA to fund treatment trials?
No. The announcement is centered on biomarker discovery and validation in peripheral tissues, and it explicitly disallows clinical trials under the NIH definition for this funding opportunity.
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