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首页> 外文期刊>Dementia and Geriatric Cognitive Disorders Extra >A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease
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A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease

机译：一项为期24周，随机，双盲，安慰剂对照的研究，旨在评估Rivastigmine贴剂对日本阿尔茨海默氏病患者的疗效，安全性和耐受性

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Background: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD) in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm2 (9-mg loading dose; 4.6 mg/24 h delivery rate) and 10-cm2 (18-mg loading dose; 9.5 mg/24 h delivery rate) rivastigmine patch in Japanese patients with AD. Results: In the primary analysis population (intent-to-treat last observation carried forward) at week 24, delayed deterioration was seen with the 10-cm2 patch versus placebo on the Japanese version of the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-J cog; p = 0.005) and the Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J; p = 0.067). Participants receiving the rivastigmine patch showed numerically less decline versus placebo at week 24 on the CIBIC plus-J, although this did not reach statistical significance. Statistical significance for the CIBIC plus-J was met following adjustment for body weight and baseline Mini-Mental State Examination score as dynamic allocation factors (p = 0.042) and on the Disability Assessment for Dementia (DAD; p = 0.024) and Mental Function Impairment (MENFIS; p = 0.016) subscales. Serious adverse events were rare and were consistent with the known safety profile of the rivastigmine patch. Conclusion: The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD.
机译：背景：自2010年起，卡巴拉汀贴片已在64个国家/地区获得治疗阿尔茨海默氏病（AD）的许可。方法：这项为期24周，多中心，随机，双盲，安慰剂对照的研究评估了5 cm 2 （9 mg剂量; 4.6 mg / 24）的疗效，安全性和耐受性日本AD患者使用rivastigmine贴剂和10-cm 2 （18 mg负荷剂量; 9.5 mg / 24 h输送速度）治疗。结果：在第24周的主要分析人群（进行了最后一次治疗意向治疗）中，在日本版的阿尔茨海默氏病患者中，使用10-cm 2 贴片与安慰剂相比观察到延迟恶化评估量表-认知子量表（ADAS-J cog; p = 0.005）和日文版的临床医生基于面试的变化印象加照顾者投入（CIBIC plus-J; p = 0.067）。在第24周时，接受卡巴拉汀贴片的参与者与安慰剂相比，在数字上减少的幅度较小，尽管这没有统计学意义。在调整体重和基线微精神状态检查得分作为动态分配因子（p = 0.042）以及痴呆残疾评估（DAD; p = 0.024）和心理功能障碍后，满足CIBIC plus-J的统计意义。 （MENFIS; p = 0.016）分量表。严重的不良事件很少见，与已知的卡巴拉汀贴剂的安全性相符。结论：卡巴拉汀贴剂在日本AD患者中具有良好的疗效和耐受性。

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