Mary Sano, Mount Sinai School of Medicine, Bronx, NY, USA,
J Prev Alzheimers Dis. 2018;5(2):98-102. doi: 10.14283/jjpad.2018.15.
For the second time in the past 3 years, the EU-US CTAD Task Force addressed challenges related to designing clinical trials for agitation in dementia, which is one of the most disruptive aspects of the condition for both patients and caregivers. Six recommendations emerged from the Task Force meeting: 1 - Operationalizing agitation criteria established by the IPA; 2 - Combining clinician- and caregiver-derived outcomes as primary outcome measures; 3 - Using global ratings to define clinically meaningful effects and power studies; 4 - Improving the accuracy of caregiver reports by better training and education of caregivers; 5 - Employing emerging technologies to collect near real-time behavioral data; and 6 - Utilizing innovative trial designs and increasing the use of biomarkers to maximize the productivity of clinical trials for neuropsychiatric symptoms.
在过去 3 年中，欧盟-美国 CTAD 工作组第二次针对痴呆相关激越的临床试验设计面临的挑战进行了探讨，这是该疾病对患者和护理人员最具破坏性的方面之一。工作组会议提出了六项建议：1. 使 IPA 确定的激越标准付诸实施；2. 将临床医生和护理人员得出的结果合并作为主要的结果衡量标准；3. 使用总体评分来定义有临床意义的效果和进行功效研究；4. 通过更好地培训和教育护理人员，提高护理人员报告的准确性；5. 采用新兴技术收集近乎实时的行为数据；6. 使用创新的试验设计并增加生物标志物的使用，最大限度地提高神经精神症状临床试验的效率。
