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首页> 外文期刊>Clinical drug investigation >Nicergoline in the Treatment of Mild-to-Moderate Alzheimer's Disease A European Multicentre Trial
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Nicergoline in the Treatment of Mild-to-Moderate Alzheimer's Disease A European Multicentre Trial

机译：尼麦角林在轻度至中度阿尔茨海默氏病治疗中的欧洲多中心试验

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Objective: To assess the long-term efficacy and tolerability of nicergoline 30mg twice daily in the treatment of mild-to-moderate Alzheimer's disease.Design: Multicentre, randomised, double-blind, placebo-controlled study of 6 months' duration.Setting: 33 investigational sites in five European countries (Italy, Sweden, UK, Belgium and Germany).Patients: 346 patients with mild-to-moderate probable Alzheimer's disease (as defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association), with Mini-Mental State Examination scores of 12 to 24, aged >50 years.Interventions: Patients were randomised to either nicergoline 30mg tablets twice daily or to matching placebo treatment for 6 months.Main Outcome Measures and Results: Primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Clinical Global Impression of Change (CGIC); the ADAS non-cognitive portion (ADAS non-cog) and total score, the Instrumental Activities of Daily Living (IADL), and the Physical Self-Maintenance Scale (PSMS) were considered as secondary measures. The completion rate was 83.6% for nicergoline and 81.1% for the placebo group. The two groups were well balanced for all demographic and disease characteristics, except education, which was higher in the placebo group. Cognitive function (ADAS-cog) at endpoint was significantly improved by nicergoline (mean change from baseline was -0.17 in the nicergoline group and 1.38 in the placebo group, p=0.04). The CGIC rating revealed a non-significantly reduced rate of deterioration in the nicergoline group; the same applied to IADL and PSMS results. ADAS non-cog non-significantly favoured the nicergoline group and fewer nicergoline patients developed newly emergent non-cognitive symptoms during the study. The ADAS total score closely reflected ADAS-cog changes. 59.9% of nicergoline and 60.9% of placebo recipients reported adverse events, usually of mild severity and self-limiting; adverse events determined discontinuation in 8.5% of nicergoline and 8.3% of placebo patients.
机译：目的：评估尼麦角林30mg每天两次治疗轻度至中度阿尔茨海默氏病的长期疗效和耐受性设计：多中心，随机，双盲，安慰剂对照研究，为期6个月。患者分布在欧洲五个国家（意大利，瑞典，英国，比利时和德国）的33个患者中。患者：346例轻度至中度可能的阿尔茨海默氏病（由美国国家神经病学和传染性疾病研究所以及中风-阿尔茨海默氏病和相关疾病协会），年龄> 50岁，最小精神状态检查分数为12至24干预：患者被随机分为每天两次两次服用麦角戈林30mg片剂或匹配安慰剂治疗6个月主要结果和结果：主要疗效指标包括阿尔茨海默氏病评估量表（ADAS-cog）和临床总体变化印象（CGIC）的认知部分;次要测量指标为ADAS非认知部分（ADAS non-cog）和总分，日常工具活动（IADL）和身体自我维持量表（PSMS）。尼麦角林的完成率为83.6％，安慰剂组为81.1％。两组的所有人口统计学特征和疾病特征均很均衡，但教育程度较高，安慰剂组除外。尼麦角林显着改善了终点的认知功能（ADAS-cog）（尼麦角林组相对于基线的平均变化为-0.17，安慰剂组为1.38，p = 0.04）。 CGIC评分显示麦角戈林组的恶化率没有显着降低。同样适用于IADL和PSMS结果。在研究中，ADAS的非齿轮非显着偏爱尼麦角林组，较少的尼麦角林患者出现新出现的非认知症状。 ADAS总分密切反映了ADAS齿轮变化。尼麦角林的59.9％和安慰剂接受者的60.9％报告了不良事件，通常为轻度和自我限制;不良事件确定8.5％的麦角戈林和8.3％的安慰剂患者停药。

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