Nakamura Yu, Kitamura Shin, Homma Akira, Shiosakai Kazuhito, Matsui Daiju
Kagawa University, Faculty of Medicine, Department of Neuropsychiatry , 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa , Japan +81 87 898 5111 ; +81 87 891 2016 ;
Expert Opin Pharmacother. 2014 May;15(7):913-25. doi: 10.1517/14656566.2014.902446. Epub 2014 Mar 27.
With the increase in the aging population, there is a pressing need to provide effective treatment options for individuals with Alzheimer's disease (AD). Memantine is an N-methyl-D-aspartate receptor antagonist used to treat AD in > 80 countries worldwide, and studies in the USA and Europe have shown it to be effective in improving language deficits; however, there are currently no data on language improvements in Japanese patients treated with memantine.
To clarify the efficacy and safety of memantine in Japanese outpatients with moderate to severe AD, using a pooled analysis of two multicenter randomized placebo-controlled trials, a phase 2 dose-finding study and a phase 3 study.
The final analysis comprised 633 patients (318 receiving memantine and 315 placebo). Memantine produced better outcomes in terms of Severe Impairment Battery-Japanese version, Clinician's Interview-Based Impression of Change plus-Japanese version, Behavioral Pathology in AD Rating Scale, and language scores, versus placebo. The overall incidence of adverse events and adverse reactions was similar between groups.
In this pooled analysis of Japanese patients, memantine achieved better outcomes than placebo in terms of cognition, including attention, praxis, visuospatial ability and language, and behavioral and psychological symptoms, including activity disturbances and aggressiveness.
随着老龄化人口的增加，迫切需要为阿尔茨海默病（AD）患者提供有效的治疗选择。美金刚是一种N-甲基-D-天冬氨酸受体拮抗剂，在全球80多个国家用于治疗AD，美国和欧洲的研究表明它能有效改善语言缺陷；然而，目前尚无关于接受美金刚治疗的日本患者语言改善情况的数据。
通过对两项多中心随机安慰剂对照试验、一项2期剂量探索研究和一项3期研究进行汇总分析，阐明美金刚对日本中重度AD门诊患者的疗效和安全性。
最终分析纳入633例患者（318例接受美金刚治疗，315例接受安慰剂治疗）。与安慰剂相比，美金刚在严重损害量表-日语版、基于临床医生访谈的变化印象加-日语版、AD行为病理评定量表和语言评分方面产生了更好的结果。两组不良事件和不良反应的总体发生率相似。
在对日本患者的这项汇总分析中，美金刚在认知方面，包括注意力、实践能力、视觉空间能力和语言，以及行为和心理症状，包括活动障碍和攻击性方面，比安慰剂取得了更好的结果。
