Supplementary Material for: Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study

<b><i>Background/Aims:</i></b> Hypersomnia is common in dementia with Lewy bodies (DLB). We assessed the efficacy, safety, and tolerability of armodafinil for hypersomnia associated with DLB. <b><i>Methods:</i></b> We performed a 12-week pilot trial of armodafinil therapy (125-250 mg orally daily) in DLB outpatients with hypersomnia. The patients underwent neurologic examinations, a neuropsychological battery, laboratory testing, electrocardiography, and polysomnography. Efficacy was assessed at 2, 4, 8, and 12 weeks. Safety assessment included laboratory examinations, QTc interval, and heart rate. Tolerability was assessed by analysis of adverse events. Data were analyzed using the last-observation-carried-forward method. <b><i>Results:</i></b> Of 20 participants, 17 completed the protocol. The median age was 72 years, most of the participants were men (80%), and most had spouses as caregivers. The Epworth Sleepiness Scale (<i>p</i> &lt; 0.001), Maintenance of Wakefulness Test (<i>p</i> = 0.003), and Clinical Global Impression of Change (<i>p</i> &lt; 0.001) scores improved at week 12. The Neuropsychiatric Inventory total score (<i>p</i> = 0.003), visual hallucinations (<i>p</i> = 0.003), and agitation (<i>p</i> = 0.02) improved at week 4. Caregiver overall quality of life improved at week 12 (<i>p</i> = 0.004). No adverse events occurred. <b><i>Conclusion:</i></b> These pilot data suggest improvements in hypersomnia and wakefulness and reasonable safety and tolerability of armodafinil therapy in hypersomnolent patients with DLB. Our findings inform the use of pharmacologic strategies for managing hypersomnolence in these patients.

**背景与研究目的**：睡眠过多症在路易体痴呆（dementia with Lewy bodies, DLB）患者中较为常见。本研究旨在评估阿莫达非尼（armodafinil）治疗路易体痴呆伴发睡眠过多症的疗效、安全性与耐受性。
**研究方法**：本研究针对伴发睡眠过多症的路易体痴呆门诊患者开展了一项为期12周的阿莫达非尼治疗先导临床试验，给药方案为每日口服125~250 mg阿莫达非尼。所有受试者均接受神经系统检查、成套神经心理学测评、实验室检测、心电图检查及多导睡眠监测。分别于治疗第2、4、8、12周评估疗效；安全性评估涵盖实验室检测、QTc间期及心率监测；耐受性通过不良事件分析进行评估。数据采用末次观测值结转法（last-observation-carried-forward, LOCF）进行统计分析。
**研究结果**：共纳入20名受试者，其中17名完成了全部试验流程。受试者中位年龄为72岁，多数为男性（占比80%），且多数以配偶作为照料者。治疗第12周时，爱泼沃斯嗜睡量表（Epworth Sleepiness Scale）、维持觉醒试验（Maintenance of Wakefulness Test）及临床总体印象变化量表（Clinical Global Impression of Change）评分均得到显著改善（*p* < 0.001、*p* = 0.003、*p* < 0.001）。治疗第4周时，神经精神问卷（Neuropsychiatric Inventory）总分、视幻觉症状及激越症状均得到改善（*p* = 0.003、*p* = 0.003、*p* = 0.02）。治疗第12周时，照料者的总体生活质量得到改善（*p* = 0.004）。本研究未观察到不良事件发生。
**研究结论**：本项先导临床试验数据显示，伴发睡眠过多症的路易体痴呆患者接受阿莫达非尼治疗后，睡眠过多症状与觉醒状态均得到改善，且治疗安全性与耐受性良好。本研究结果可为该类患者的嗜睡症状药物管理提供临床参考依据。