A Randomized, Double-Blind, Placebo-Controlled Trial of Modafinil for the Treatment of Apathy in Individuals With Mild-to-Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Trial of Modafinil for the Treatment of Apathy in Individuals With Mild-to-Moderate Alzheimer's Disease
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DOI：
10.4088/jcp.10m06708
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发表时间：
2012-06-01
影响因子：
5.3
通讯作者：
Malloy, Paul
中科院分区：
文献类型：
--
作者：
Frakey, Laura L.;Solloway, Stephen;Malloy, Paul
目的：本研究探讨了莫达非尼对阿尔茨海默病 (AD) 患者精神萎靡症状、日常生活活动能力 (ADL) 和照护者负担的影响。方法：23 名根据国家神经和交流障碍和中风-阿尔茨海默病及相关疾病研究所标准诊断为轻度至中度疑似 AD 的参与者被随机分为实验组（莫达非尼 200 毫克每天）或对照组（安慰剂）。所有参与者还接受稳定剂量的胆碱酯酶抑制剂药物。参与者在基线时和治疗 8 周后完成评估。结果测量包括家庭报告的冷漠程度、ADL 表现和照顾者负担的测量，以及 ADL 表现的直接评估。该研究于 2005 年 9 月至 2007 年 9 月在罗德岛州的一家私立精神病医院进行。 结果：实验组和对照组在基线和最终评估之间的额叶系统行为量表上的冷漠程度均有所下降（F-1，F-20 = 18.017，P < .001，eta(2) = 0.474），并且在冷漠方面没有显着的额外减少莫达非尼（F-1、F-20 = 0.008，P = .932，eta(2) = 0.000）。随着时间的推移，各组的护理人员报告的 ADL 表现没有显示出显着变化（F-1、F-19 = 0.268，P = .611）。冷漠变化与照护者负担变化之间的相关性并不显着（r = 0.355，P = .053），但冷漠水平的改善有与照护者负担水平降低相关的趋势。结论：在标准护理治疗（胆碱酯酶抑制剂药物）中添加莫达非尼并没有导致冷漠程度的显着额外减少或 ADL 功能的改善。在基线和最终评估之间观察到的两组报告的冷漠程度的减少可能是由于安慰剂效应。然而，感知到的冷漠症状的减少与报告的护理人员痛苦和负担的减少相关。需要具有更强统计能力的更大规模研究来证实不存在显着影响。
Objective: This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs), and caregiver burden in individuals with Alzheimer's disease (AD).Method: 23 participants with a diagnosis of mild-to-moderate probable AD according to National Institute of Neurologic and Communicative Disorder and Stroke-Alzheimer's Disease and Related Disorders criteria were randomized into the experimental (modafinil 200 mg daily) or control (placebo) groups. All participants were also receiving stable doses of a cholinesterase inhibitor medication. Participants completed assessments at baseline and after 8 weeks of treatment. Outcome measures included family report measures of apathy, ADL performance, and caregiver burden, as well as direct assessment of ADL performance. The study was conducted at a private psychiatric hospital in Rhode Island from September 2005 until September 2007.Results: Both the experimental and control groups showed reductions in apathy on the Frontal Systems Behavior Scale between baseline and final assessments (F-1,F-20 = 18.017, P < .001, eta(2) = 0.474), and there was no significant additional reduction in apathy with modafinil (F-1,F-20 = 0.008, P = .932, eta(2) = 0.000). Groups did not show significant changes in caregiver report of ADL performance over time (F-1,F-19 = 0.268, P = .611). The correlation between change in apathy and change in caregiver burden was not significant (r = 0.355, P = .053), but there was a trend toward improved levels of apathy being related to decreased levels of caregiver burden.Conclusions: The addition of modafinil to the standard of care treatment (cholinesterase inhibitor medication) did not result in significant additional reductions in apathy or improvements in ADL functioning. The reduction in reported apathy observed in both groups between baseline and final assessments was likely due to placebo effect. However, reductions in perceived apathetic symptomatology were correlated with reductions in reported caregiver distress and burden. Larger studies with more statistical power are needed to confirm the absence of significant effects.