1. Regulatory considerations for developing remote measurement technologies for Alzheimer's disease research.
- Author
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Erdemli, Gül, Grammatikopoulou, Margarita, Wagner, Bertil, Vairavan, Srinivasan, Curcic, Jelena, Aarsland, Dag, Wittenberg, Gayle, Nikolopoulos, Spiros, Muurling, Marijn, Froehlich, Holger, de Boer, Casper, Shanbhag, Niraj M., Nies, Vera J. M., Coello, Neva, Gove, Dianne, Diaz, Ana, Foy, Suzanne, Dartee, Wim, and Brem, Anna-Katharine
- Subjects
ALZHEIMER'S disease diagnosis ,DIGITAL technology ,MOBILE apps ,ALZHEIMER'S disease ,INTERPROFESSIONAL relations ,WEARABLE technology ,FUNCTIONAL status ,TELEMEDICINE ,MEDICAL consultation ,MEDICAL research ,GOVERNMENT regulation - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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