Multicenter research on efficacy and tolerance of memantine in Chinese patients with Alzheimer's disease
- VernacularTitle:美金刚在阿尔茨海默病患者中的疗效与耐受性多中心研究
- Author:
Xia CHEN
;
Zhen-Xin ZHANG
;
Xin-De WANG
;
Jing-Li YAO
;
Sheng-Di CHEN
;
Cai-Yun QIAN
;
Shi-Fu XIAO
;
Liang SHU
;
Hong-chuan TANG
- Publication Type:Journal Article
- Keywords:
Alzheimer disease;
Memantine;
Drug resistance;
Receptors,N-methyl-Daspartate
- From:
Chinese Journal of Neurology
1999;0(06):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of memantine in the treatment of patients with Alzheimer' s disease (AD).Methods This was a 16-week,multi-center,randomized,double blind, placebo-controlled clinical trial (Study 10116).A total of 258 AD patients (MMSE score 5—18) were randomized in a 1:1 ratio into either memantine 10—20 mg/day (MEM,n=128) or placebo (PBO,n= 130) group for 16 weeks.Efficacy was primarily assessed in terms of changes of severe impairment battery (SIB) score in patients from baseline up to SIB assessment in the 16th week (16-week completers set, CS16).While ehanges of MMSE,ADCS-ADL_(19),and NPI (neuropsychiatric inventory) were evaluated as secondary efficacy parameters on both CSI6 and full-analysis set (FAS).Safety was assessed by physical examination,lab assays,ECG,and adverse events.Results 236 subjeets (CS16:MEM n=117,PBO n=119) were eligible for the efficacy assessment.No statistically significant difference between the treatments was observed on the primary and seeondary efficacy analysis,although both treatment groups had a slight increase from baseline in SIB total score.Post hoe evaluation of the data identified two bias factors that had a significant impact on the results of the pre-protoeol specified primary and secondary analyses.In a re-analysis of the data (CS16_(modified),MEM n=94,PBO n=95) excluding patient data affeeted by these factors,memantine-treated patients showed a statistically significant improvement related to placebo in the 16th week on the SIB (MEM 2.2 vs PBO 0.3,P=0.04),MMSE (MEM 1.0 vs PBO 0.1,P=0.03),and ADL (MEM 0.1 vs PBO-1.6,P=0.02) scales,indicating that memantine improved the cognitive function of AD patients and stabilized the activity of daily life.Memantine was well tolerated with an adverse event profile similar to that of placebo.Conclusion This study provides further support for pre-existing data,showing that memantine is efficacious,safe,and well-tolerated in patients with moderate to severe AD.
