NCT00500500终止2 期
Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
研究概览
简要总结
The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female or male of 50 to 85 years old with a care giver
- •Mini Mental Status (MMS) test between 16 to 26 inclusive
- •Clinical Dementia Rating (CDR) test inferior or equal to 1
- •National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
- •Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia
排除标准
- •patient already treated by medicines which could interfere with the study
- •low level of vitamin B12 and folate which are considered as clinically relevant
- •clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness....)
研究组 & 干预措施
EGb 761® (Tanakan®)
Experimental
EGb 761® (Tanakan®)
干预措施: EGb 761® (Tanakan®) (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: EGb 761® (Tanakan®) (Drug)
结局指标
主要结局
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
时间窗: Every visit
次要结局
- Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day(Every visit)
研究者
研究点 (1)
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