Redefining ALS Clinical Endpoints: Unlocking The Potential Of Digital Health Technologies

Despite years of dedicated research, progress in Amyotrophic Lateral Sclerosis (ALS) drug development has been hindered by repeated late-stage trial failures, with many studies unable to achieve their primary outcomes. These challenges reflect not only the biological complexity and variability of ALS but also ongoing difficulties in trial design, patient stratification, and biomarker validation. Moreover, the reliance on traditional endpoints has exposed their limitations, reinforcing the need for more precise, objective, and comprehensive measures of disease progression and therapeutic impact.

This edition of Digital Health Monthly focuses on how cross-disciplinary collaboration can help address these critical issues. Participants will learn how innovative digital health tools can augment conventional endpoints by capturing subtle, continuous changes across multiple domains, including motor performance, respiratory capacity, sleep quality, speech patterns, and cognitive function. The discussion brings together diverse experts to share practical insights and perspectives on advancing the integration and validation of digital endpoints in ALS clinical research.

ALS continues to be a devastating and incurable condition, underscoring the urgent need for effective new treatments. By combining rigorous evidence generation with collaboration across academia, industry, and regulatory bodies, the field can move toward standardized and credible digital outcome measures — laying the groundwork for faster, more impactful therapeutic breakthroughs for people living with ALS.