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.

Details

Title
Regulatory considerations for developing remote measurement technologies for Alzheimer’s disease research
Author
Erdemli, Gül 1   VIAFID ORCID Logo  ; Grammatikopoulou, Margarita 2 ; Wagner, Bertil 3 ; Vairavan, Srinivasan 3   VIAFID ORCID Logo  ; Curcic, Jelena 4   VIAFID ORCID Logo  ; Aarsland, Dag 5   VIAFID ORCID Logo  ; Wittenberg, Gayle 3   VIAFID ORCID Logo  ; Nikolopoulos, Spiros 2 ; Muurling, Marijn 6 ; Froehlich, Holger 7   VIAFID ORCID Logo  ; de Boer, Casper 6 ; Shanbhag, Niraj M. 8 ; Nies, Vera J. M. 9 ; Coello, Neva 10   VIAFID ORCID Logo  ; Gove, Dianne 11 ; Diaz, Ana 11 ; Foy, Suzanne 12 ; Dartee, Wim 10 ; Brem, Anna-Katharine 13   VIAFID ORCID Logo 

 Novartis Pharmaceuticals Corporation, Cambridge, USA (GRID:grid.418424.f) (ISNI:0000 0004 0439 2056) 
 Centre for Research & Technology Hellas, Information Technologies Institute, Thessaloniki, Greece (GRID:grid.423747.1) (ISNI:0000 0001 2216 5285) 
 LLC, a Johnson & Johnson company, Janssen Research & Development, Titusville, USA (GRID:grid.497530.c) (ISNI:0000 0004 0389 4927) 
 Novartis, Biomedical Research, Basel, Switzerland (GRID:grid.419481.1) (ISNI:0000 0001 1515 9979) 
 Stavanger University Hospital, Centre for Age-Related Medicine, Stavanger, Norway (GRID:grid.412835.9) (ISNI:0000 0004 0627 2891); King’s College London, Centre for Healthy Brain Ageing, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, London, UK (GRID:grid.13097.3c) (ISNI:0000 0001 2322 6764) 
 Vrije Universiteit Amsterdam, Amsterdam UMC location VUmc, Alzheimer Center Amsterdam, Neurology, Amsterdam, The Netherlands (GRID:grid.16872.3a) (ISNI:0000 0004 0435 165X); Neurodegeneration, Amsterdam Neuroscience, Amsterdam, The Netherlands (GRID:grid.484519.5) 
 Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Department of Bioinformatics, Sankt Augustin, Germany (GRID:grid.418688.b) (ISNI:0000 0004 0494 1561); Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn-Aachen International Center for IT, Bonn, Germany (GRID:grid.10388.32) (ISNI:0000 0001 2240 3300) 
 Inc, Takeda Development Center Americas, Lexington, USA (GRID:grid.419849.9) (ISNI:0000 0004 0447 7762) 
 Foundation Lygature, Utrecht, The Netherlands (GRID:grid.491493.2) 
10  Novartis Pharma AG, Basel, Switzerland (GRID:grid.419481.1) (ISNI:0000 0001 1515 9979) 
11  Alzheimer Europe, Luxembourg, Luxembourg (GRID:grid.424021.1) (ISNI:0000 0001 0739 010X) 
12  a Johnson & Johnson company, Janssen Research & Development UK, High Wycombe, UK (GRID:grid.507827.f) 
13  King’s College London, Centre for Healthy Brain Ageing, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, London, UK (GRID:grid.13097.3c) (ISNI:0000 0001 2322 6764); University of Bern, University Hospital of Old Age Psychiatry, Bern, Switzerland (GRID:grid.5734.5) (ISNI:0000 0001 0726 5157) 
Pages
232
Publication year
2024
Publication date
Dec 2024
Publisher
Nature Publishing Group
e-ISSN
23986352
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3100711558
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.