NCT01172145已完成3 期
Treatment of Apathy in Alzheimer's Disease With Modafinil
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Apathy
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of mild to moderate stage Probable Alzheimer's disease
- •on a stable dose of a cholinesterase inhibitor medication for at least 30 days
- •clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale
排除标准
- •diagnosis of Major Depression
- •focal brain lesion on neuroimaging
- •history of significant substance abuse
- •history of significant head trauma with loss if consciousness >10 minutes
研究组 & 干预措施
Cholinesterase inhibitor only
Placebo Comparator
干预措施: Placebo (Drug)
Cholinesterase Plus Modafinil
Experimental
干预措施: Modafinil (Drug)
结局指标
主要结局
Apathy
时间窗: after 8 weeks of treatment
The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
次要结局
- Lawton Brody Activities of Daily Living Questionnaire(after 8 weeks of treatment)
- The Direct Assessment of Functional Status Scale(after 8 weeks of treatment)
- Zarit Burden Inventory(after 8 weeks of treatment)
研究者
研究点 (1)
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