Prodromal Synucleinopathies Consortium (U19 Clinical Trial Optional) | RFA AG 21 013

Opportunity Information: Apply for RFA AG 21 013

The Prodromal Synucleinopathies Consortium (U19 Clinical Trial Optional) funding opportunity (RFA-AG-21-013) is an NIH cooperative agreement designed to build a coordinated, multi-site research consortium focused on idiopathic REM sleep behavior disorder (iRBD). The core goal is to establish and run a longitudinal, prospective study that follows people with iRBD over time because iRBD is widely viewed as an important prodromal (early, pre-diagnostic) phase for alpha-synuclein-related neurodegenerative diseases, such as Parkinson's disease, dementia with Lewy bodies, and related synucleinopathies. In practice, the opportunity is aimed at accelerating progress on early identification, disease trajectory mapping, and biomarker development by creating a structured network that can recruit participants, collect harmonized data across sites, and observe conversion from prodromal symptoms into clinically diagnosable neurodegenerative outcomes.

Mechanistically, this is a cooperative agreement (U19), which means awardees should expect substantial NIH involvement in the project’s coordination, oversight, and milestone-driven execution compared with a typical investigator-initiated grant. The "Clinical Trial Optional" designation signals that applicants may propose work that includes a clinical trial component, but they are not required to do so; observational longitudinal cohort work is clearly central, and trial elements would need to be justified as fitting the consortium’s aims. The FOA is positioned in NIH’s health research portfolio and is associated with CFDA numbers 93.853 and 93.866, reflecting NIH funding lines relevant to aging and neuroscience-oriented research.

The intended study model is multi-site and prospective, meaning sites would enroll eligible participants and follow them forward in time using consistent protocols. A major value of this structure is scale and standardization: iRBD cohorts can be difficult to build at a single center, and differences in clinical assessments, sleep study confirmation, biospecimen handling, imaging methods, and follow-up schedules can limit cross-study comparisons. By supporting a consortium, NIH is effectively prioritizing harmonized recruitment and data collection so researchers can more reliably compare participant trajectories, identify predictors of progression, and develop or validate measures that could serve as endpoints for future prevention or early-intervention trials.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities, such as state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (excluding higher education for those categories); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as Native American tribal organizations that are not federally recognized. The FOA also explicitly highlights 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, regional organizations, eligible federal agencies, tribal governments other than federally recognized ones, and U.S. territories or possessions. At the same time, it draws a clear boundary around foreign involvement: 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 NIH defines them in the NIH Grants Policy Statement) are allowed, which generally means limited, well-justified international elements can be included under a U.S. applicant organization when permitted and appropriately documented.

From an administrative standpoint, the opportunity was created on February 18, 2020, with an original closing date of June 17, 2020. The award ceiling listed is $3,000,000, indicating NIH expected proposals at a scale appropriate for multi-site coordination, longitudinal follow-up, and the infrastructure needed to maintain a high-quality consortium dataset over time. The listing notes "ExpectedAwards:" without a number provided in the excerpt, so the exact count of awards is not specified in the supplied text.

Overall, this FOA is best understood as NIH’s push to organize the field around a shared, rigorously characterized iRBD cohort that can function as a platform for discovery and validation. By focusing on iRBD as a prodromal synucleinopathy state, the consortium approach is meant to shorten the path from observing early clinical features to identifying reliable biomarkers and risk signatures, and ultimately to enabling earlier, better-targeted intervention studies for diseases driven by alpha-synuclein pathology.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Prodromal Synucleinopathies Consortium (U19 Clinical Trial Optional)" 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 2020-02-18.
• Applicants must submit their applications by 2020-06-17. (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 $3,000,000.00 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 RFA AG 21 013

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