Digital biomarkers: Redefining clinical outcomes and the concept of meaningful change

Minimal clinically important difference (MCID) represents the smallest change in a patient's condition that would be considered meaningful, but defining this for Alzheimer's disease is challenging due to its heterogeneity.The perception of what is clinically meaningful may differ at the individual level, at different disease stages within the same individual, and between patient and caregiver.Traditional tests used as endpoints in Alzheimer's trials lack the sensitivity to detect subtle changes and are limited by range restrictions, making them less effective for accurately capturing treatment efficacy.Digital biomarkers and artificial intelligence (AI)-driven health technologies may offer the potential to enhance the detection of clinically meaningful changes by providing continuous, objective monitoring and advanced analytics for individualized patient assessments.Both the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) are playing pivotal roles in advancing the use of digital health technologies, facilitating the evolution of regulatory frameworks to ensure these innovations are effectively integrated into clinical research and practice.