Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required) | PAR 24 168

Opportunity Information: Apply for PAR 24 168

This NIH funding opportunity (PAR-24-168) supports early-stage, proof-of-concept feasibility clinical trials that use music-based interventions to address brain disorders of aging. It reissues a prior announcement (PAR-24-256) and uses the R34 mechanism, which is designed to help teams do the kind of preparatory clinical trial work needed before launching a larger, more definitive efficacy, effectiveness, or pragmatic trial. The central expectation is that applicants will design and run a small, well-structured feasibility study that is explicitly guided by the NIH Music-based Interventions (MBI) Toolkit, and that the resulting data will both test the Toolkit's guiding principles in real-world research settings and generate the pilot evidence needed to justify and shape a subsequent full-scale clinical trial.

The scientific focus is on brain disorders commonly associated with aging, including (but not limited to) Alzheimer's disease and Alzheimer's disease-related dementias, Parkinson's disease, and stroke. Projects should use music-based interventions in a clinical trial context and collect data that address important gaps in knowledge about how to design, implement, and evaluate these interventions in the target populations. The emphasis is not on proving definitive clinical benefit yet, but on demonstrating that the proposed approach is feasible and credible enough to warrant a larger trial later. That typically means producing concrete evidence on issues like whether the intervention can be delivered as planned, whether participants can be recruited and retained, whether adherence and fidelity can be maintained, whether outcome measures are acceptable and sensitive enough, and whether study procedures are practical across the intended setting(s). In other words, the work should reduce uncertainty and de-risk the next-stage trial by showing that the key moving parts actually work in practice.

Because this is a "clinical trial required" opportunity, the funded work must meet NIH's definition of a clinical trial, meaning participants are prospectively assigned to an intervention and the study assesses an effect on health-related biomedical or behavioral outcomes. The NOFO frames these projects as feasibility trials that are intended to inform a later, larger clinical efficacy or effectiveness study. Applicants are expected to use the feasibility trial to refine core design elements that will matter later, such as intervention dosing and delivery format, comparison conditions, recruitment pipelines, participant eligibility definitions, the choice and timing of outcomes, blinding or masking where possible, and analytic plans appropriate for the next phase. The overall goal is to leave the project with a clear, evidence-backed blueprint for a competitive large-scale clinical trial application.

A wide range of U.S.-based organizations can apply. 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; nonprofit organizations (with or without 501(c)(3) status); public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The NOFO also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, and U.S. territories or possessions.

At the same time, foreign organizations are not eligible to apply as applicant institutions, and non-U.S. components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined by the NIH Grants Policy Statement, meaning an otherwise eligible U.S. applicant may include certain foreign elements in the project when justified and structured according to NIH policy. The sponsoring agency is the National Institutes of Health, and the funding activity falls under the health category, with CFDA numbers 93.213 and 93.866. The original closing date listed for this opportunity is 2024-11-19. The posted record does not specify an award ceiling or the expected number of awards in the excerpt provided, so applicants would need to consult the full NOFO text and NIH budgeting guidance for specifics on allowable budgets and project period details under the R34 mechanism.

In practical terms, a strong application under this NOFO would present a tightly scoped clinical trial that uses the NIH MBI Toolkit to justify the intervention framework and study decisions, clearly defines feasibility milestones and success criteria, and explains how the pilot results will directly inform a later-stage clinical trial. The review-relevant value is the quality of the feasibility questions, the rigor and realism of the trial procedures, and the usefulness of the resulting pilot data for building a persuasive, scalable next-step efficacy or effectiveness trial in aging-related brain disorders.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.866.
• This funding opportunity was created on 2024-04-10.
• Applicants must submit their applications by 2024-11-19. (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 PAR 24 168

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