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数字技术在阿尔茨海默病临床试验中作为生物标志物、临床结局评估和招募工具的应用。

Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer's disease clinical trials.

作者信息

Gold Michael, Amatniek Joan, Carrillo Maria C, Cedarbaum Jesse M, Hendrix James A, Miller Bradley B, Robillard Julie M, Rice J Jeremy, Soares Holly, Tome Maria B, Tarnanas Ioannis, Vargas Gabriel, Bain Lisa J, Czaja Sara J

机构信息

AbbVie Inc., North Chicago, Illinois, USA.

Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.

出版信息

Alzheimers Dement (N Y). 2018 May 24;4:234-242. doi: 10.1016/j.trci.2018.04.003. eCollection 2018.

Abstract

Digital technology is transforming the development of drugs for Alzheimer's disease and was the topic of the Alzheimer's Association's Research Roundtable on its May 23-24, 2017 meeting. Research indicates that wearable devices and unobtrusive passive sensors that enable the collection of frequent or continuous, objective, and multidimensional data during daily activities may capture subtle changes in cognition and functional capacity long before the onset of dementia. The potential to exploit these technologies to improve clinical trials as both recruitment and retention tools as well as for potential end points was discussed. The implications for the collection and use of large amounts of data, lessons learned from other related disease areas, ethical concerns raised by these new technologies, and regulatory issues were also covered in the meeting. Finally, the challenges and opportunities of these new technologies for future use were discussed.

摘要

数字技术正在改变阿尔茨海默病药物的研发进程,并且是2017年5月23日至24日阿尔茨海默病协会研究圆桌会议的主题。研究表明,可穿戴设备以及能在日常活动期间收集频繁或连续、客观且多维度数据的非侵入式无源传感器,可能早在痴呆症发作之前就能捕捉到认知和功能能力的细微变化。会上讨论了利用这些技术改善临床试验的可能性,这些技术可作为招募和留住患者的工具,也可用于潜在的终点指标。会议还涵盖了大量数据收集和使用的影响、从其他相关疾病领域吸取的经验教训、这些新技术引发的伦理问题以及监管问题。最后,讨论了这些新技术未来应用所面临的挑战和机遇。

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