An Hoyoung, Choi Booyeol, Park Kun-Woo, Kim Do-Hoon, Yang Dong-Won, Hong Chang Hyung, Kim Seong Yoon, Han Seol-Heui
National Institute of Dementia, Seongnam, South Korea.
Department of Psychiatry, Seoul National University Bundang Hospital, Seongnam, South Korea.
J Alzheimers Dis. 2017;55(2):727-735. doi: 10.3233/JAD-160225.
Effective treatments to alleviate depression in Alzheimer's disease (AD) have been scarce.
To investigate the efficacy and tolerability of escitalopram in the treatment of depression in AD.
In this 12-week randomized, double-blind, placebo-controlled trial with open-label, 12-week extension, AD subjects over 50 years of age, with depression defined by Olin's provisional diagnostic criteria, were enrolled. The Cornell Scale for Depression in Dementia (CSDD), and other measures of depression and cognition were repeated.
91 subjects were screened, and 84 were randomized into either the study group or placebo group (n = 42 for both groups). Twenty-four subjects (29%) were unable to finish the study, yielding a per protocol population of 60 subjects (study group: n = 27; placebo group: n = 33). At week 12, differences in measures of depression and cognition between the two groups were not statistically significant. However, exploratory analysis suggested that further research on a subset of subjects with 'definite major depression' (baseline CSDD score ≥18) is needed. The number of treatment-related adverse-events (AE) did not differ between groups (p = 0.83) and no serious treatment-related AE were observed.
The use of escitalopram was well tolerated in depressive dementia patients. Future studies focusing on subjects with more severe levels of depression, and with more statistical power, will be needed.
治疗阿尔茨海默病(AD)抑郁症状的有效疗法一直很匮乏。
探讨艾司西酞普兰治疗AD抑郁症状的疗效和耐受性。
在这项为期12周的随机、双盲、安慰剂对照试验中,纳入了50岁以上、符合奥林临时诊断标准的AD抑郁患者,该试验设有12周的开放标签延长期。重复使用康奈尔痴呆抑郁量表(CSDD)以及其他抑郁和认知测量方法。
共筛选出91名受试者,其中84名被随机分为研究组或安慰剂组(每组n = 42)。24名受试者(29%)未能完成研究,最终符合方案人群为60名受试者(研究组:n = 27;安慰剂组:n = 33)。在第12周时,两组之间的抑郁和认知测量指标差异无统计学意义。然而,探索性分析表明,需要对“明确的重度抑郁”(基线CSDD评分≥18)的受试者子集进行进一步研究。两组之间与治疗相关的不良事件(AE)数量无差异(p = 0.83),且未观察到严重的与治疗相关的AE。
艾司西酞普兰在抑郁性痴呆患者中耐受性良好。未来需要针对抑郁程度更严重、统计学效力更强的受试者开展研究。