NCT00702780已完成不适用
Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- % Change of Whole Brain Volume
研究概览
简要总结
This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.
详细描述
- Study institutions: Four university hospitals in Korea
- Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial
- Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:40~90 years
- •Education:not illiterate
- •Clinical Dementia Rating (CDR):0.5~2
- •Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4
- •Dementia according to DSM-IV criteria
- •Probable Alzheimer's disease according to NINCDS-ADRDA criteria
- •Current ongoing donepezil medication at stable doses (5 ~ 10 mg/day) for at least 2 months
- •Exclusion criteria:
- •Evidence of delirium, confusion or altered consciousness
- •Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus
- •Evidence of infectious or inflammatory brain disease
- •Evidence of serious cerebrovascular diseases
- •Current major depressive disorder or other major psychiatric illnesses
- •Evidence of serious or unstable medical illnesses which can significantly change cognitive state
- •History of alcohol or other substance dependence
- •Any antidepressant medications within the previous 4 weeks
- •Absence of a reliable and cooperative collateral informant
- •Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia
- •Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale
排除标准
- 未提供
研究组 & 干预措施
Escitalopram
Experimental
Escitalopram 20mg tablet by mouth once a day
干预措施: escitalopram (Drug)
Placebo
Placebo Comparator
Placebo 20mg tablet by mouth once a day
干预措施: placebo (Drug)
结局指标
主要结局
% Change of Whole Brain Volume
时间窗: 52 weeks
% Change of Hippocampus Volume
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
Dong Young Lee
Professor
Seoul National University Hospital
研究点 (4)
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