Froelich L, Gertz H-J, Heun R, Heuser I, Jendroska K, Kornhuber J, Kurz A, Mueller-Thomsen T, Ries F, Waechtler C, Metz M, Goebel C
Division of Geriatric Psychiatry, Central Institute for Mental Health Mannheim, University of Heidelberg, Heidelberg, Germany.
Dement Geriatr Cogn Disord. 2004;18(1):37-43. doi: 10.1159/000077733. Epub 2004 Apr 6.
This multicenter open-label clinical trial was designed to investigate the safety and efficacy of donepezil, a selective acetylcholinesterase inhibitor, in the treatment of Alzheimer's disease (AD) in routine clinical practice in Germany. A total of 237 patients with mild-to-moderate AD were treated with donepezil for 24 weeks, 186 completed the study according to the protocol. In the completer group, mean MMSE score for efficacy showed an improvement from baseline of +1.6 points at week 12 (95% CI +1.1 to +2.1) and of +1.1 points at week 24 (95% CI +0.5 to +1.7). In more than 80% of the patients, global tolerability was rated to be very good or good. There were only insignificant effects on ECG parameters. This study confirms the results obtained in previous double-blind trials, which showed that donepezil is effective and well tolerated in patients with mild-to-moderately severe AD.
这项多中心开放标签临床试验旨在研究选择性乙酰胆碱酯酶抑制剂多奈哌齐在德国常规临床实践中治疗阿尔茨海默病（AD）的安全性和有效性。共有237例轻度至中度AD患者接受多奈哌齐治疗24周，186例患者按方案完成了研究。在完成研究的患者组中，疗效方面的平均简易精神状态检查表（MMSE）评分在第12周时较基线提高了1.6分（95%置信区间为+1.1至+2.1），在第24周时提高了1.1分（95%置信区间为+0.5至+1.7）。超过80%的患者总体耐受性被评为非常好或良好。对心电图参数仅有不显著的影响。本研究证实了先前双盲试验的结果，表明多奈哌齐对轻度至中度重度AD患者有效且耐受性良好。
