Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in amyotrophic lateral sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients.

Distinctive Features: To meet the intent of the funding opportunity, applications may address clinical biomarkers and/or clinical outcomes. This may include the identification, development, and/or validation of promising biomarkers for ALS, which may include, but are not limited to susceptibility/risk, diagnostic, monitoring/disease progression, prognostic, predictive, response, or safety biomarkers. Clinical Outcomes projects may focus on the identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS. Projects may include the optimization of current outcome measures already in use.

Applications may utilize digital health measures, including wearable devices, smart-phone sensors, video or voice recordings, imaging studies, or other devices which record disease-relevant physiological data and/or outcomes.

Community Collaboration is an important element of the FY26 ALSRP COBA. Applicants will be expected to articulate how the proposed research question or study design was informed by the

ALS lived experience community.