DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award | HT942525ALSRPCOBA

Opportunity Information: Apply for HT942525ALSRPCOBA

The FY25 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) is a discretionary research grant opportunity administered by the Department of the Army through USAMRAA. Its purpose is to strengthen ALS clinical trials by supporting projects that develop and/or validate better clinical outcome measures and biomarkers. The program is aimed at work that can make trials more informative, efficient, and interpretable, for example by improving how disease progression is tracked, how patients are stratified, or how treatment response and safety are measured. Importantly, proposed tools do not need to be universally applicable to every ALS patient; the announcement explicitly allows projects tailored to a specific therapy, a class of therapeutics, or a defined ALS subtype such as a particular genetic mutation.

Applicants must address one or both of two focus areas. The first focus area is Clinical Biomarkers, which covers identification, development, and/or validation of promising ALS biomarkers. The announcement is intentionally broad about biomarker types and includes susceptibility or risk biomarkers, diagnostic biomarkers, monitoring or disease progression biomarkers, prognostic biomarkers, predictive biomarkers, response biomarkers, and safety biomarkers. In practical terms, this can include work that helps determine who is likely to develop ALS, supports earlier or more accurate diagnosis, tracks progression over time with greater sensitivity than existing tools, predicts clinical trajectory, identifies which patients are more likely to benefit from a given therapy, shows whether a therapy is working, or flags adverse effects.

The second focus area is Clinical Outcomes, which supports identification, development, and/or validation of outcome measures that can be used in ALS studies and trials. These outcomes can be clinician-reported, observer-reported (such as caregiver inputs), patient-reported outcomes, and/or performance-based measures. The scope includes not only completely new instruments but also efforts to refine and optimize outcome measures already in use, which could involve improving reliability, sensitivity to change, feasibility in multicenter settings, or relevance to patient priorities. The overarching intent is to produce outcome measures that more accurately reflect meaningful change in ALS and that can be deployed in clinical research to evaluate interventions.

Across both focus areas, the opportunity permits the use of digital health measures. This includes wearables, smartphone sensors, video or voice recordings, imaging studies, and other devices that capture disease-relevant physiological data or functional outcomes. This flexibility signals interest in modern measurement approaches that can potentially provide higher-frequency data, reduce patient burden, capture real-world function, or detect subtle changes that conventional clinic-based assessments may miss.

A distinctive requirement applies to projects that involve prospective biospecimen collection or participant enrollment: those applications must incorporate a Community Collaboration as described in the solicitation’s Attachment 9. In effect, if a project is going to collect new samples or enroll people prospectively, the proposal needs to include a structured collaboration with the relevant community, reflecting an expectation for meaningful engagement and partnership rather than purely researcher-driven recruitment or collection.

From an administrative standpoint, the opportunity number is HT942525ALSRPCOBA, the funding instrument is a grant, and the activity category is Science and Technology and other Research and Development (CFDA 12.420). Eligibility is listed as unrestricted, and the original closing date is August 27, 2025. The announcement anticipates making about five awards, with the award ceiling not specified in the provided excerpt.

• The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on 2025-04-18.
• Applicants must submit their applications by 2025-08-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 5 candidate(s).
• Eligible applicants include: Unrestricted.

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