Mamikonyan Eugenia, Xie Sharon X, Melvin Emilie, Weintraub Daniel
Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA.
Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA.
Mov Disord. 2015 Jun;30(7):912-8. doi: 10.1002/mds.26236. Epub 2015 Apr 25.
Mild cognitive impairment (MCI) in Parkinson's disease (PD) may be associated with subtle functional impairment and worse quality of life. The objective of this study was to determine the efficacy and tolerability of rivastigmine for PD-MCI. Patients with PD-MCI (n = 28) were enrolled in a 24-week, randomized, double-blind, placebo-controlled, crossover, single-site study of the rivastigmine transdermal patch. The primary outcome measure was the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). Secondary outcomes included the Montreal Cognitive Assessment (MoCA), Dementia Rating Scale-2 (DRS-2), Neurotrax computerized cognitive battery, the Everyday Cognition Battery (ECB), and the Parkinson's Disease Questionnaire (PDQ-8). Twenty-six participants (92.9%) completed both study phase assessments, and 23 (82.1%) completed both phases on study medication. The CGIC response rate demonstrated a trend effect in favor of rivastigmine (regression coefficient for interaction term in linear mixed-effects model = 0.44, F[df] = 3.01 [1, 24], P = 0.096). For secondary outcomes, a significant rivastigmine effect on the ECB (regression coefficient = -2.41, F[df] = 5.81 [1, 22.05], P = 0.03) was seen, but no treatment effect was found on any cognitive measures. Trend effects also occurred in favor of rivastigmine on the PDQ-8 (regression coefficient = 4.55, F[df] = 3.93 [1, 14. 79], P = 0.09) and the State Anxiety Inventory (regression coefficient = -1.24, F[df] = 3.17 [1, 33], P = 0.08). Rivastigmine in PD-MCI showed a trend effect for improvements on a global rating of cognition, disease-related health status, and anxiety severity, and significant improvement on a performance-based measure of cognitive abilities. © 2015 International Parkinson and Movement Disorder Society.
帕金森病(PD)中的轻度认知障碍(MCI)可能与细微的功能损害及较差的生活质量相关。本研究的目的是确定卡巴拉汀治疗帕金森病合并轻度认知障碍(PD-MCI)的疗效和耐受性。将28例PD-MCI患者纳入一项为期24周的、随机、双盲、安慰剂对照、交叉、单中心的卡巴拉汀透皮贴剂研究。主要结局指标是阿尔茨海默病协作研究-临床总体变化印象(ADCS-CGIC)。次要结局包括蒙特利尔认知评估(MoCA)、痴呆评定量表2(DRS-2)、Neurotrax计算机化认知测试组合、日常认知测试组合(ECB)以及帕金森病问卷(PDQ-8)。26名参与者(92.9%)完成了两个研究阶段的评估,23名(82.1%)在研究药物治疗下完成了两个阶段。CGIC缓解率显示出有利于卡巴拉汀的趋势效应(线性混合效应模型中交互项的回归系数=0.44,F[自由度]=3.01[1,24],P=0.096)。对于次要结局,观察到卡巴拉汀对ECB有显著影响(回归系数=-2.41,F[自由度]=5.81[1,22.05],P=0.03),但在任何认知指标上均未发现治疗效果。在PDQ-8(回归系数=4.55,F[自由度]=3.93[1,14.79],P=0.09)和状态焦虑量表(回归系数=-1.24,F[自由度]=3.17[1,33],P=0.08)上也出现了有利于卡巴拉汀的趋势效应。卡巴拉汀在PD-MCI中显示出在认知总体评分、疾病相关健康状况和焦虑严重程度改善方面的趋势效应,以及在基于表现的认知能力测量方面的显著改善。©2015国际帕金森病和运动障碍协会。