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Safety and efficacy of methylphenidate for apathy in Alzheimer's Disease: A randomized, placebo-controlled trial

机译:阿尔茨海默病治疗哌甲酯的安全性和疗效:随机,安慰剂对照试验

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摘要

Objective: In a recent crossover trial, methylphenidate treatment decreased apathy in Alzheimer's disease. We further assessed this finding in the Apathy in Dementia Methylphenidate Trial (ADMET). Method: Six-week, randomized, double-blind, placebocontrolled multicenter trial enrolling Alzheimer's disease participants (NINCDS-ADRDA criteria) with apathy assigned to methylphenidate 20 mg daily or placebo, conducted from June 2010 to December 2011. Primary outcomes were change in Apathy Evaluation Scale (AES) score and modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGI-C). Secondary outcomes included change in Neuropsychiatric Inventory (NPI) apathy score, Mini-Mental State Examination (MMSE) score, and safety. Results: 60 participants were randomly assigned (29 methylphenidate, 31 placebo). At baseline, mean (SD) age = 76 (8) years, MMSE score = 20 (5), AES score = 51 (12), NPI total score = 16 (8), and 62% of the participants (n = 37) were female. After 6 weeks' treatment, mean (SD) change in AES score was -1.9 (1.5) for methylphenidate and 0.6 (1.4) for placebo (P = .23). Odds ratio for improvement in ADCS-CGI-C was 3.7 (95% CI, 1.3 to 10.8) (P = .02), with 21% of methylphenidate versus 3% of placebo rated as moderately or markedly improved. NPI apathy score improvement was 1.8 points (95% CI, 0.3 to 3.4) greater on methylphenidate than on placebo (P = .02). MMSE trended toward improvement on methylphenidate (P = .06). There were trends toward greater anxiety and weight loss > 2% in the methylphenidate-treated group. Conclusions: Methylphenidate treatment of apathy in Alzheimer's disease was associated with significant improvement in 2 of 3 efficacy outcomes and a trend toward improved global cognition with minimal adverse events, supporting the safety and efficacy of methylphenidate treatment for apathy in Alzheimer's disease.
机译:目的:在最近的交叉试验中,甲基酚酸盐治疗在阿尔茨海默病的疾病下降。我们进一步评估了这种发现在痴呆症甲基透明审判(ACCET)中的脾气院。方法:从2010年6月到2011年6月,分配给Alzheimer的疾病参与者(Nincds-Adrda标准)的多中心试验(Nincds-Adrda标准)的多中心试验从2010年6月到2011年12月进行。评估规模(AES)得分和改性阿尔茨海默病合作研究 - 临床全球变化印象(ADCS-CGI-C)。二次结果包括神经心理库存(NPI)冷漠评分的变化,迷你精神状态检查(MMSE)得分和安全性。结果:60名参与者被随机分配(29甲基苯甲酸甲酯,31个安慰剂)。在基线时,平均值(SD)年龄= 76(8)年,MMSE得分= 20(5),AES得分= 51(12),NPI总得分= 16(8),以及62%的参与者(n = 37 )是女性。在6周后的治疗后,AES评分的平均值(SD)变化为-1.9(1.5),用于安慰剂的0.6(1.4)(p = .23)。 ADCS-CGI-C改善的差距为3.7(95%CI,1.3至10.8)(P = .02),其中21%的甲基酚相对于适度或显着改善的安慰剂的3%。甲基透明度的NPI冷漠分数改善比安慰剂更大的甲基透明剂(p = .02)更大。 MMSE趋向于改善甲基苯胺(P = .06)。在甲基酚治疗组中有更大的焦虑和体重减轻的趋势趋势。结论:阿尔茨海默病治疗脾脏治疗脾脏的治疗与3个疗效结果的显着改善以及改善全球认知的趋势,致力于最小的不良事件,支持甲基酚酸盐治疗对阿尔茨海默病治疗的安全性和有效性。

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    Department of Psychiatry and Behavioral Sciences Johns Hopkins School of Medicine Baltimore MD;

    Department of Psychiatry Brain Sciences Research Program Sunnybrook Research Institute ON;

    Department of Epidemiology Johns Hopkins Bloomberg School of Public Health Baltimore MD United;

    Department of Psychiatry Brain Sciences Research Program Sunnybrook Research Institute ON;

    Department of Epidemiology Johns Hopkins Bloomberg School of Public Health Baltimore MD United;

    Alzheimer's Research and Clinical Programs Ralph H. Johnson VA Medical Center Medical University;

    Alzheimer's Research and Clinical Programs Ralph H. Johnson VA Medical Center Medical University;

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  • 正文语种 eng
  • 中图分类 精神病学;
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