Wesnes K A, McKeith I G, Ferrara R, Emre M, Del Ser T, Spano P F, Cicin-Sain A, Anand R, Spiegel R
Cognitive Drug Research Ltd, Reading, University of Newcastle upon Tyne, UK.
Dement Geriatr Cogn Disord. 2002;13(3):183-92. doi: 10.1159/000048651.
This study was designed to assess the effects of rivastigmine (Exelon) on the cognitive functioning of patients suffering from dementia with Lewy bodies. This was a prospective, multi-centre, randomised, double-blind, placebo-controlled exploratory study conducted at sites in the UK, Spain and Italy. The treatment period was 20 weeks with a 3-week posttreatment follow-up. The primary outcome measures were the Cognitive Drug Research (CDR) computerised assessment system and the Neuropsychiatric Inventory. Testing was conducted prior to dosing and then again at weeks 12, 20 and 23. Analysis of the data from the 92 patients who completed the study identified a significant pattern of benefits of rivastigmine over placebo on the CDR system. These benefits were seen on tests of attention, working memory and episodic secondary memory. Taking attention for example, patients given placebo showed a significant deterioration from predosing scores at 12 and 20 weeks, whereas patients on rivastigmine performed significantly above their predosing levels. These effects were also large in magnitude, the decline under placebo at week 12 being 19%, while the improvement under rivastigmine was 23%. The clinical relevance of this 23% improvement was that it took the patients 33% towards being normal for their age on this assessment of attention. These benefits to cognitive function were accompanied by a significant improvement of the other primary outcome measure, the Neuropsychiatric Inventory. Three weeks after discontinuation of rivastigmine, most parameters of cognitive performance returned to predrug levels.
本研究旨在评估卡巴拉汀（艾斯能）对路易体痴呆患者认知功能的影响。这是一项在英国、西班牙和意大利的研究地点进行的前瞻性、多中心、随机、双盲、安慰剂对照的探索性研究。治疗期为20周，治疗后随访3周。主要结局指标为认知药物研究（CDR）计算机评估系统和神经精神科问卷。在给药前以及第12、20和23周再次进行测试。对完成研究的92例患者的数据进行分析后发现，在CDR系统上，卡巴拉汀相对于安慰剂有显著的获益模式。在注意力、工作记忆和情景性二级记忆测试中均可见到这些获益。以注意力测试为例，给予安慰剂的患者在第12周和第20周时相对于给药前的分数有显著下降，而服用卡巴拉汀的患者表现显著高于其给药前水平。这些效应的幅度也很大，第12周时安慰剂组的下降幅度为19%，而卡巴拉汀组的改善幅度为23%。这23%的改善在临床上的意义在于，在这项注意力评估中，这使患者在其年龄对应的正常水平上达到了33%。对认知功能的这些获益伴随着另一个主要结局指标神经精神科问卷的显著改善。停用卡巴拉汀3周后，大多数认知表现参数恢复到用药前水平。
