NCT01614886已完成3 期
A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch (ENA713D/ONO-2540) in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-20)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation
研究概览
简要总结
To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.
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
- •A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
- •A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
- •An MMSE score of ≥ 10 and ≤ 20 at baseline
排除标准
- •Any medical or neurological conditions other than AD that could explain the patient's dementia
- •A current diagnosis of probable or possible vascular dementia
- •A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
- •A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
- •Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
- •an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1 step
Experimental
干预措施: Active Comparator (Drug)
3 step
Active Comparator
干预措施: ENA713 (Drug)
结局指标
主要结局
Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation
时间窗: Up to 24 weeks
The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.
次要结局
- The Percentage of Treatment Retention.(Up to 24 weeks)
- Change From Baseline in Mini-Mental State Examination (MMSE)(Baseline and 24 weeks)
- Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)(Baseline, 8,16, and 24 weeks)
- Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly(4, 8, 12,16, 20 and 24 weeks)
研究者
研究点 (1)
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