Lewy Body Dementia Center Without Walls (CWOW) (U54 Clinical Trial Not Allowed) | RFA NS 19 013

Opportunity Information: Apply for RFA NS 19 013

The Lewy Body Dementia Center Without Walls (CWOW) (U54 Clinical Trial Not Allowed) funding opportunity (RFA NS 19 013) is a National Institutes of Health (NIH) cooperative agreement designed to build a coordinated, multi-project research center focused on the biology of Lewy Body Dementia (LBD) using human post-mortem brain tissue. The central scientific aim is to systematically and comprehensively identify and characterize the different molecular "subspecies" (distinct forms, assemblies, or species) of two proteins that are strongly implicated in LBD pathology: alpha-synuclein and amyloid-beta. The opportunity is structured to push beyond broad protein measurements and instead map out the specific forms of these proteins that exist in LBD brain, determine which of those forms are most toxic, and clarify how they might drive disease through specific mechanisms.

A key emphasis of the FOA is that applicants must focus on human tissues, especially post-mortem brain samples from individuals with LBD. The work is expected to rigorously characterize alpha-synuclein and amyloid-beta subspecies found in these tissues, identify which subspecies are associated with toxicity, and investigate mechanistic pathways by which toxicity occurs. In addition, the FOA specifically calls for research into interactions between alpha-synuclein and amyloid-beta. That includes studying whether these proteins influence each other in ways that increase toxicity, accelerate pathology, or help explain why particular cell types, brain regions, or neural circuits show selective vulnerability in LBD.

The required overall structure is that of a Center program (U54) with multiple integrated parts. Applications must include at least three hypothesis-driven research projects, meaning the center cannot be a loosely connected set of exploratory activities; each project needs a clear scientific hypothesis and a plan to test it. In addition to the projects, the application must include an Administrative Core to manage coordination, communication, governance, and shared oversight across the Center. Applicants may also propose additional cores as needed (for example, cores that provide shared methods, tissue handling, biochemistry, structural characterization, proteomics, data management, neuropathology, or computational analysis), as long as those cores support the Center's required aims and improve efficiency and integration across projects.

A major expected deliverable is a plan to develop a publicly available library of fully characterized alpha-synuclein and amyloid-beta subspecies found in LBD. In practice, this means the Center is expected not only to discover and define these subspecies in human tissue, but also to package the results in a way the broader research community can access and use. The intention is to create shared reference materials and/or datasets that enable other scientists to compare findings across studies, improve reproducibility, and accelerate downstream work such as assay development, biomarker research, or target validation. The public-access expectation also signals a strong emphasis on community resource building rather than a closed, single-lab effort.

Because this is labeled "Clinical Trial Not Allowed," applications are not intended to include prospective interventional studies in humans that meet the NIH definition of a clinical trial. The research focus is fundamentally mechanistic and tissue-based, centered on post-mortem human brain analyses and related experimental approaches used to define protein subspecies, assess toxicity, and test interaction hypotheses.

From an administrative standpoint, the opportunity is offered as a discretionary NIH cooperative agreement, which typically means substantial NIH program involvement is anticipated compared with a standard grant. The funding activity category is Health, and the CFDA numbers listed are 93.853 and 93.866. The posting was created on 2018-10-29, with an original closing date of 2019-01-04. An award ceiling and expected number of awards are not specified in the provided source text.

Eligibility is broad and includes many types of U.S. organizations and some non-U.S. entities. Eligible applicants include state, county, and local governments; 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); small businesses; and other categories. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities/foreign organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. This broad eligibility aligns with the Center model and encourages multi-institutional, multidisciplinary collaborations capable of assembling the tissue resources, specialized methods, and integrated project structure needed to meet the FOA's deliverables.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Lewy Body Dementia Center Without Walls (CWOW) (U54 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 2018-10-29.
• Applicants must submit their applications by 2019-01-04. (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 19 013

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