Summary: The fiscal year 2025 (FY25) 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.

To meet the intent of the funding opportunity, applications must address ONE or BOTH of the following focus areas:

• Clinical Biomarkers: Identification, development, and/or validation of promising biomarkers for ALS. Biomarkers may include, but are not limited to susceptibility/risk, diagnostic, monitoring/disease progression, prognostic, predictive, response, or safety biomarkers.

• Clinical Outcomes: Identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS. Projects may include optimization of current outcome measures already in use.

Both focus areas are permitted to 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.

Distinctive Features: Applications proposing prospective biospecimen collection or participant enrollment are required to incorporate a Community Collaboration, as described in Attachment 9.

Miscellaneous

• Unrestricted