A 24-week Randomized, Controlled Trial of Memantine in Patients With Moderate-to-severe Alzheimer Disease
A 24-week Randomized, Controlled Trial of Memantine in Patients With Moderate-to-severe Alzheimer Disease
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美金刚治疗中重度阿尔茨海默病患者的 24 周随机对照试验
DOI：
10.1097/wad.0b013e318065c495
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发表时间：
2007
影响因子：
2.1
通讯作者：
E. Malca Resnick
中科院分区：
文献类型：
--
作者：
C. V. van Dyck;P. Tariot;B. Meyers;E. Malca Resnick
本研究探讨了美金刚单药治疗中重度阿尔茨海默病（AD）患者的疗效和安全性。在这项为期24周的双盲安慰剂对照试验中，未接受胆碱酯酶抑制剂治疗的患者（N=350）随机接受美金刚（20 mg/d）或安慰剂治疗。尽管在第12周和第18周观察到美金刚胺治疗的显著优势，但在第24周终点时，在严重损害成套测验（SIB）上，研究者定义的分析未能证明美金刚胺治疗与安慰剂相比具有统计学显著性益处。在任何分析中，19项阿尔茨海默病合作研究-日常生活活动量表（ADCS-ADL 19）在组间均无显著差异。临床医生访谈的变化印象加上护理人员输入（CIBIC-Plus）在第24周时并不显著有利于美金刚，尽管美金刚在第12周和第18周时具有显著优势。其他次要结局显示无显著治疗差异。对潜在混杂协变量的事后分析和插补缺失数据的替代方法未显著改变结果。由于SIB和ADCS-ADL 19违反了正态性假设，因此进行了非参数分析;在第24周时，SIB而非ADCS-ADL 19显示了美金刚相对于安慰剂的统计学显著性获益。两组不良事件的类型和发生率相似。
This study examined the efficacy and safety of memantine monotherapy in patients with moderate-to-severe Alzheimer disease (AD). Patients not receiving a cholinesterase inhibitor (N=350) were randomized to receive memantine (20 mg/d) or placebo during this 24-week, double-blind, placebo-controlled trial. Prospectively defined analyses failed to demonstrate a statistically significant benefit of memantine treatment compared with placebo on the Severe Impairment Battery (SIB) at week 24 end point, although a significant advantage was observed for memantine at weeks 12 and 18. The 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL19) did not differ significantly between groups in any analysis. Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-Plus) did not significantly favor memantine at week 24 despite a significant advantage for memantine at weeks 12 and 18. Other secondary outcomes showed no significant treatment differences. Post hoc analyses of potentially confounding covariates and alternative methods of imputing missing data did not substantially alter the results. Because of the violations of normality assumptions for the SIB and ADCS-ADL19, nonparametric analyses were performed; statistically significant benefit of memantine over placebo was demonstrated at week 24 for the SIB but not the ADCS-ADL19. The type and incidence of adverse events were similar in both groups.
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影响因子：
2.1
作者：
L. Schneider;J. Olin;R. Doody;C. M. Clark;J. Morris;B. Reisberg;F. Schmitt;M. Grundman;R. G. Thomas;S. Ferris
通讯作者：
L. Schneider;J. Olin;R. Doody;C. M. Clark;J. Morris;B. Reisberg;F. Schmitt;M. Grundman;R. G. Thomas;S. Ferris
影响因子：
120.7
作者：
Tariot, PN;Farlow, MR;Gergel, I
通讯作者：
Gergel, I
影响因子：
158.5
作者：
Reisberg, B;Doody, R;Mobius, HJ
通讯作者：
Mobius, HJ
影响因子：
2.1
作者：
Lipton, Stuart A.
通讯作者：
Lipton, Stuart A.