Regulatory considerations for developing remote measurement technologies for Alzheimer’s disease research
oleh: Gül Erdemli, Margarita Grammatikopoulou, Bertil Wagner, Srinivasan Vairavan, Jelena Curcic, Dag Aarsland, Gayle Wittenberg, Spiros Nikolopoulos, Marijn Muurling, Holger Froehlich, Casper de Boer, Niraj M. Shanbhag, Vera J. M. Nies, Neva Coello, Dianne Gove, Ana Diaz, Suzanne Foy, Wim Dartee, Anna-Katharine Brem
| Format: | Article |
|---|---|
| Diterbitkan: | Nature Portfolio 2024-09-01 |
Deskripsi
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.