一项为期24周的美金刚治疗中度至重度阿尔茨海默病的开放标记延伸研究  

A 24- week open-label extension study of memantine in moderate to severe alzheimer disease

作　　者：Reisberg B Doody R Stffler A 李一明 

机构地区：[1]William and Sylvia Silberstein Aging and Dementia Research and Treatment Center, New York University, School of Medicine, 550 First Ave, New York, NY 10016, United States,Dr.

出　　处：《世界核心医学期刊文摘（神经病学分册）》2006年第5期18-18,共1页Digest of the World Core Medical Journals:Clinical Neurology

摘　　要：Background: This study is an extension of a 28- week, randomized, double-blind, placebo-controlled study of memantine in 252 patients with moderate to severe Alzheimer disease. Objective: To evaluate long-term memantine treatment in moderate to severe Alzheimer disease. Design, Setting, and Patients: Open-label, 24- week extension trial. Raters remained blind to the patients’ initial study treatment. Patients (n=175) were enrolled from the previous double-blind study in an outpatient setting. Intervention: Twenty mg of memantine was given daily. Main Outcome Measures: Efficacy assessments from the double-blind study were continued and safety parameters were monitored. Results: Patients who switched to memantine treatment from their previous placebo therapy experienced a significant benefit in all main efficacy assessments (functional, global, and cognitive) relative to their mean rate of decline with placebo treatment during the double-blind period (P < .05). The completion rate for the extension phase of the study was high (78% ) and the favorable adverse event profile for memantine therapy was similar to that seen in the double-blind study. Conclusion: These results extend previous findings that demonstrated the efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease.Background： randomized, This study is double-blind, an extension of a 28- week, placebo-controlled study of memantine in 252 patients with moderate to severe Alzheimer disease. Objective： To evaluate long-term memantine treatment in moderate to severe Alzheimer disease. Design, Setting, and Patients： Open-label, 24-week extension trial. Raters remained blind to the patients＇ initial study treatment. Patients （n = 175） were enrolled from the previous double-blind study in an outpatient setting. Intervention： Twenty mg of memantine was given daily. Main Outcome Measures： Efficacy assessments from the double-blind study were continued and safety parameters were monitored. Results： Patients who switched to memantine treatment from their previous placebo therapy experienced a significant benefit in all main efficacy assessments （functional, global, and cognitive） relative to their mean rate of decline with placebo treatment during the double-blind period （P 〈. 05） . The completion rate for the extension phase of the study was high （78%） and the favorable adverse event profile for memantine therapy was similar to that seen in the double-blind study. Conclusion： These results extend previous findings that demonstrated the efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease.

关 键 词：阿尔茨海默病患者 延伸试验 治疗情况 美金刚 重度 中度 安慰剂治疗 双盲研究 疗效评估 平均下降率 

分 类 号：R749.16[医药卫生—神经病学与精神病学] R542.22[医药卫生—临床医学]