Treatments for Lewy Body Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required) | RFA NS 21 008

Opportunity Information: Apply for RFA NS 21 008

The Treatments for Lewy Body Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required) opportunity (RFA-NS-21-008) is a National Institutes of Health (NIH) funding announcement that supports early-stage, patient-focused clinical testing of potential treatments specifically in people living with Lewy Body Dementia (LBD). The goal is to move promising therapeutic ideas into real-world evaluation through exploratory clinical trials that can generate practical safety, dosing, feasibility, and preliminary efficacy data. Because this is a U01 cooperative agreement, NIH expects substantial scientific involvement from the funding institute during the project, meaning the award functions as a collaboration rather than a completely investigator-directed grant.

Applications are expected from experienced clinical researchers who can run well-designed exploratory trials in LBD populations. The announcement allows either Phase I or Phase II clinical trials, depending on how mature the proposed intervention is. Phase I proposals would typically focus on early human safety, tolerability, dose-ranging, and pharmacokinetics or device feasibility in an LBD cohort. Phase II proposals would generally aim to provide initial signals of benefit while continuing to monitor safety, often using clinical endpoints appropriate to LBD. A key requirement is that the trial must include participants with LBD; the program is not intended for trials that only study related disorders without enrolling LBD patients.

The range of interventions NIH is interested in is broad. Applicants can propose novel drugs or devices, as well as repurposed or existing treatments that are not currently approved for LBD but have a credible rationale for benefit. The announcement highlights interest in two major therapeutic directions: disease-modifying approaches intended to prevent, slow, or delay progression, and symptomatic therapies intended to reduce the burden of existing clinical problems. Symptom-focused studies can address motor symptoms (for example, parkinsonism-related features) and non-motor symptoms (which in LBD commonly include cognitive fluctuations, neuropsychiatric symptoms, sleep-related issues, and autonomic problems). In practice, this means proposals can be competitive whether they target underlying biology or aim to improve day-to-day functioning and quality of life, as long as the study is designed as a rigorous clinical trial in an LBD population.

From an administrative standpoint, this is a discretionary health funding opportunity using a cooperative agreement mechanism. It is associated with CFDA numbers 93.853 and 93.866, and it is issued by NIH. The opportunity was created on 2020-10-28 and had an original closing date of 2021-03-02. The source information provided does not specify an award ceiling or the expected number of awards, which suggests applicants would need to consult the full NIH notice for budget constraints, project period limits, and any institute-specific funding expectations.

Eligibility is intentionally broad across many organization types, reflecting NIH norms for clinical research funding. Eligible applicants include state, county, city or township 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; public housing authorities/Indian housing authorities; for-profit organizations other than small businesses; small businesses; and federally recognized Native American tribal governments as well as tribal organizations that are not federally recognized. The announcement also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian 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, and U.S. territories or possessions.

Restrictions on foreign participation are also clearly stated. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S.-based applicant organization may include certain scientifically justified activities or collaborations that occur abroad, provided they meet NIH policy requirements and are appropriately documented.

Overall, this opportunity is designed to accelerate therapeutic development for Lewy Body Dementias by funding carefully planned, exploratory Phase I or Phase II clinical trials that directly enroll LBD patients and evaluate promising drugs, devices, or repurposed interventions. The emphasis is on generating solid early clinical evidence that can justify and inform subsequent, larger confirmatory trials, while leveraging the cooperative U01 structure to align investigators and NIH staff around trial quality, feasibility, and meaningful outcomes for the LBD community.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Treatments for Lewy Body Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required)" 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 2020-10-28.
• Applicants must submit their applications by 2021-03-02. (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 21 008

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