Regulatory considerations for developing remote measurement technologies for Alzheimer’s disease research,npj Digital Medicine

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Regulatory considerations for developing remote measurement technologies for Alzheimer’s disease research
npj Digital Medicine ( IF 12.4 ) Pub Date : 2024-09-04 , DOI: 10.1038/s41746-024-01211-8
Gül Erdemli ₁ , Margarita Grammatikopoulou ₂ , Bertil Wagner ₃ , Srinivasan Vairavan ₃ , Jelena Curcic ₄ , Dag Aarsland _{5,

6} , Gayle Wittenberg ₃ , Spiros Nikolopoulos ₂ , Marijn Muurling _{7,

8} , Holger Froehlich _{9,

10} , Casper de Boer _{7,

8} , Niraj M Shanbhag ₁₁ , Vera J M Nies ₁₂ , Neva Coello ₁₃ , Dianne Gove ₁₄ , Ana Diaz ₁₄ , Suzanne Foy ₁₅ , Wim Dartee ₁₃ , Anna-Katharine Brem _{6,

16}

Affiliation

Novartis Pharmaceuticals Corporation, Cambridge, MA, USA.
Information Technologies Institute, Centre for Research & Technology Hellas, Thessaloniki, Greece.
Janssen Research & Development, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
Biomedical Research, Novartis, Basel, Switzerland.
Centre for Age-Related Medicine, Stavanger University Hospital, Stavanger, Norway.
Centre for Healthy Brain Ageing, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Alzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC location VUmc, Amsterdam, The Netherlands.
Amsterdam Neuroscience, Neurodegeneration, Amsterdam, The Netherlands.
Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Sankt Augustin, Germany.
Bonn-Aachen International Center for IT, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
Takeda Development Center Americas, Inc, Lexington, MA, USA.
Foundation Lygature, Utrecht, The Netherlands.
Novartis Pharma AG, Basel, Switzerland.
Alzheimer Europe, Luxembourg, Luxembourg.
Janssen Research & Development UK, a Johnson & Johnson company, High Wycombe, UK.
University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland.

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.

中文翻译：

开发用于阿尔茨海默病研究的远程测量技术的监管考虑

疾病和复发远程评估 - 阿尔茨海默病 (RADAR-AD) 联盟评估了用于评估 AD 功能状态的远程测量技术 (RMT)。该联盟与欧洲药品管理局 (EMA) 合作，获取有关有意义的功能域识别、RMT 选择和临床研究设计的反馈，以评估在 AD 临床研究中使用 RMT 的可行性。我们总结了反馈和经验教训以指导未来的项目。

更新日期：2024-09-04

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