Jeffrey Kaye, Layton Aging and Alzheimer's Disease Center, School of Medicine, Oregon Health and Science University, Portland, OR, USA,
J Prev Alzheimers Dis. 2021;8(4):513-519. doi: 10.14283/jpad.2021.36.
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.
2020 年 COVID-19 大流行扰乱了全球范围内的阿尔茨海默病（AD）临床研究。数字技术可以通过在疾病过程中远程评估微妙的认知和功能变化，帮助将干扰降至最低。欧盟/美国阿尔茨海默病临床试验（CTAD）工作组于 2020 年 11 月虚拟会议，探讨了在 AD 临床研究中使用数字技术的相关机遇和挑战。尽管认识到数字工具具有加速临床试验、提高不同人群参与度、获取具有临床意义的数据和降低成本的潜力，但数字数据的稳定性、有效性、通用性和可重复性仍存在疑问。对监管部门的认可和隐私问题也存在很大的担忧。尽管如此，工作组还是支持通过协作和数据共享进一步探索数字技术，并指出需要对数字读数进行标准化。他们还得出结论，虽然对于新型实验性药物的试验采用远程评估可能还为时过早，但目前可能可以进行非侵入性、多领域方法的远程研究。
