NCT00829374已完成3 期
CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil
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
- 1,003
- 主要终点
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
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 mild to moderate Alzheimer's disease on Donepezil.
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
- •Mild-to-moderate Alzheimer's disease (AD)
- •Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
- •Mini-Mental State Examination (MMSE) score between 12 and 24, 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
1
Experimental
Dimebon, 5 mg orally three times daily
干预措施: Dimebon (Drug)
2
Experimental
Dimebon, 20 mg orally three times daily
干预措施: Dimebon (Drug)
3
Placebo Comparator
Placebo orally three times daily
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
时间窗: Week 52
Alzheimer's Disease Assessment Scale - Cognitive Subscale
时间窗: Week 52
次要结局
- Euro Quality of Life 5 (EQ-5D)(Week 52)
- Resource Utilization in Dementia Lite (RUD lite)(Week 52)
- Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)(Week 52)
- Neuropsychiatric Inventory (NPI)(Week 52)
研究者
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