NCT00276510已完成4 期
Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 2,878
- 试验地点
- 695
- 主要终点
- EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis
研究概览
简要总结
The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneously reporting a memory complaint
- •Short anxiety battery test < 6, (only if patient screened at GP site)
- •Geriatric depression scale < 15
- •Mini-mental state (MMS) > 25 in GP's office (in hospital site MMS is done as complementary scale)
排除标准
- •Objective memory impairment
- •Clinician rated dementia staging system > 0.5
- •Mini-mental state < 25
- •Dementia, past history of seizures, Parkinson disease
研究组 & 干预措施
1
Experimental
干预措施: EGb 761® (Tanakan®) (Drug)
2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis
时间窗: Baseline, month 12, 24, 36, 48 and 60
次要结局
- Clinical safety(Baseline, month 12, 24, 36, 48 and 60)
- Concomitant treatments' reports(Baseline, month 12, 24, 36, 48 and 60)
- Efficacy on rate of cognitive abilities decline(Baseline, month 12, 24, 36, 48 and 60)
- Effect on concomitant diseases(Baseline, month 12, 24, 36, 48 and 60)
- Global evaluation of memory complaint by the patient(Baseline, month 12, 24, 36, 48 and 60)
研究者
研究点 (695)
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