Regulatory considerations for developing remote measurement technologies for Alzheimer's disease research.

Erdemli, Gül; Grammatikopoulou, Margarita; Wagner, Bertil; Vairavan, Srinivasan; Curcic, Jelena; Aarsland, Dag; Wittenberg, Gayle; Nikolopoulos, Spiros et al. · NPJ Digit Med · 2024

expert_opinion · Level V

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Abstract

The Remote Assessment of Disease and Relapse – Alzheimer’s Disease (RADAR-AD) consortium evaluated remote measurement technologies (RMTs) for assessing functional status in AD. The consortium engaged with the European Medicines Agency (EMA) to obtain feedback on identification of meaningful functional domains, selection of RMTs and clinical study design to assess the feasibility of using RMTs in AD clinical studies. We summarized the feedback and the lessons learned to guide future projects.