TY - JOUR
T1 - Using Digital Tools to Advance Alzheimer’s Drug Trials During a Pandemic
T2 - The EU/US CTAD Task Force
AU - the EU/US CTAD Task Force
AU - Kaye, Jeffrey
AU - Aisen, P.
AU - Amariglio, R.
AU - Au, R.
AU - Ballard, C.
AU - Carrillo, M.
AU - Fillit, H.
AU - Iwatsubo, T.
AU - Jimenez-Maggiora, G.
AU - Lovestone, S.
AU - Natanegara, F.
AU - Papp, K.
AU - Soto, M. E.
AU - Weiner, M.
AU - Vellas, B.
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/9
Y1 - 2021/9
N2 - The 2020 COVID-19 pandemic has disrupted Alzheimer’s disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer’s Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.
AB - The 2020 COVID-19 pandemic has disrupted Alzheimer’s disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer’s Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.
KW - Alzheimer’s disease
KW - clinical outcomes
KW - digital tools
KW - remote assessments
UR - http://www.scopus.com/inward/record.url?scp=85110419680&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85110419680&partnerID=8YFLogxK
U2 - 10.14283/jpad.2021.36
DO - 10.14283/jpad.2021.36
M3 - Article
C2 - 34585227
AN - SCOPUS:85110419680
SN - 2426-0266
VL - 8
SP - 513
EP - 519
JO - The journal of prevention of Alzheimer's disease
JF - The journal of prevention of Alzheimer's disease
IS - 4
ER -