NCT00954590终止3 期
CONTACT: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Six-Month Safety and Efficacy Study of Dimebon in Patients With Moderate-to-Severe Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 89
- 主要终点
- Neuropsychiatric Inventory (NPI)
研究概览
简要总结
The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate-to-Severe Alzheimer's disease
- •Mini-Mental State Examination (MMSE) Score between 5 to 14, inclusive
- •Stable on donepezil for at least 6 months
排除标准
- •Other causes of dementia
- •Major structural brain disease
- •Unstable medical condition or significant hepatic or renal disease
研究组 & 干预措施
Dimebon (latrepirdine)
Experimental
Dimebon, 20 mg orally three times daily
干预措施: Dimebon (latrepirdine) (Drug)
Placebo
Placebo Comparator
Placebo orally three times daily
干预措施: Placebo (Drug)
结局指标
主要结局
Neuropsychiatric Inventory (NPI)
时间窗: 26 weeks post baseline
To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)
Activities of Daily Living (severe) (ADCS ADLsev)
时间窗: 26 weeks post baseline
To evaluate the efficacy of dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer's Disease Cooperative Study - Activities of Daily Living (severe) (ADCS ADLsev).
次要结局
未报告次要终点
研究者
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