Bergamasco B, Villardita C, Coppi R
III Neurologic Clinic, University of Turin, Italy.
Arch Gerontol Geriatr. 1992 Nov-Dec;15(3):271-8. doi: 10.1016/0167-4943(92)90062-9.
A controlled double blind randomised open multicentre study was carried out on 104 patients with multi-infarct dementia (MID) from a mild to a moderate degree. The patients were randomly assigned to balanced blocks in each center and treated for 90 days either with idebenone (CV-2619) 90 mg/daily or placebo, after a 2-week turn-in period. The Gottfries Rating Scale, SCAG, Rey's A Figure Test, Rey's 15 Words Test, Token Test, Verbal Fluidity Test and the Blessed Dementia Test were used for assessment. The data were statistically analyzed using parametric and non-parametric tests. Seven patients were excluded (5 idebenone + 2 placebo) after a few days treatment, for reasons not related to drug administration; therefore, 97 patients were assessed for efficacy and 104 for tolerability. A certain placebo effect was found in the examination results but it never achieved the efficacy levels of idebenone. The latter is particularly effective for improving recent and remote memory, attention, orientation, vigilance and verbal comprehension and the effects continued even after a month of placebo treatment. There were no important adverse reactions and neither laboratory parameters nor clinical vital signs were significantly altered.
对104例轻度至中度多梗死性痴呆（MID）患者进行了一项对照双盲随机开放多中心研究。患者在各中心被随机分配到平衡区组，在经过2周的导入期后，接受艾地苯醌（CV - 2619）90mg/日或安慰剂治疗90天。使用戈特弗里德评定量表、SCAG、雷氏A图测验、雷氏15词测验、代币测验、言语流畅性测验和布列斯痴呆测验进行评估。数据采用参数检验和非参数检验进行统计学分析。治疗几天后，7例患者（5例艾地苯醌 + 2例安慰剂）因与药物给药无关的原因被排除；因此，97例患者接受疗效评估，104例接受耐受性评估。在检查结果中发现了一定的安慰剂效应，但从未达到艾地苯醌的疗效水平。艾地苯醌在改善近期和远期记忆、注意力、定向力、警觉性和言语理解方面特别有效，即使在安慰剂治疗1个月后，这些效果仍持续存在。未出现重要不良反应，实验室参数和临床生命体征均未发生显著改变。
