PPaul Aisen, Alzheimer's Therapeutic Research Institute (ATRI), Keck School of Medicine, University of Southern California, San Diego, CA, USA,
J Prev Alzheimers Dis. 2017;4(2):116-124. doi: 10.14283/jpad.2017.13.
At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient- and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.
在 2016 年 12 月举行的欧盟/美国/阿尔茨海默病临床试验（CTAD）工作组会议上，来自工业界、学术界和监管机构的一组国际研究人员审查了正在进行和计划进行的预防试验中吸取的经验教训，这将有助于指导未来 AD 治疗的临床试验，特别是在临床前领域。工作组讨论了临床试验所有方面都需要解决的挑战，呼吁在招募和保留、基础设施开发以及选择结果测量方面进行创新。虽然认知变化为整个疾病连续体中的疾病进展提供了一个标志物，但仍需要确定提供临床有意义终点的最佳评估工具。患者和知情人报告的认知和功能评估可能有用，但也带来了额外的挑战。成像和其他生物标志物对于最大限度地提高临床试验的效率和从中获得的信息也是至关重要的。
