Reisberg Barry, Doody Rachelle, Stöffler Albrecht, Schmitt Frederick, Ferris Steven, Möbius Hans Jörg
Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA.
Arch Neurol. 2006 Jan;63(1):49-54. doi: 10.1001/archneur.63.1.49.
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.
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.
Twenty mg of memantine was given daily.
Efficacy assessments from the double-blind study were continued and safety parameters were monitored.
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.
These results extend previous findings that demonstrated the efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease.
本研究是一项针对252例中度至重度阿尔茨海默病患者进行的为期28周的美金刚随机、双盲、安慰剂对照研究的扩展研究。
评估美金刚用于中度至重度阿尔茨海默病的长期治疗效果。
设计、地点和患者：开放标签、为期24周的扩展试验。评估者对患者最初的研究治疗情况保持盲态。患者（n = 175）来自之前在门诊进行的双盲研究。
每日给予20毫克美金刚。
继续采用双盲研究中的疗效评估方法，并监测安全性参数。
相对于双盲期接受安慰剂治疗时的平均衰退率，从之前的安慰剂治疗转而接受美金刚治疗的患者在所有主要疗效评估（功能、整体和认知方面）中均有显著改善（P <.05）。该研究扩展阶段的完成率较高（78%），美金刚治疗的不良事件情况良好，与双盲研究中的情况相似。
这些结果扩展了之前的研究发现，即美金刚治疗中度至重度阿尔茨海默病患者具有疗效和安全性。
