A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-23) Switched From Cholinesterase Inhibitors (Donepezil, Galantamine)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)
研究概览
简要总结
This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 > or = 10 and < or = 23
- •Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
- •Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
- •Inadequate compliance with the ChE inhibitors at screening and baseline
- •Presence of caregiver's burden for administering drugs orally at screening and baseline
- •Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
- •Patients with swallowing difficulties at screening and baseline
排除标准
- •A current DSM-IV diagnosis of major depression
- •Taken rivastigmine in the past
- •A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Rivastigmine 18 mg
During the 16-week titration period patients received daily rivastigmine 4.5mg patch for the first 4 weeks, rivastigmine 9mg patch for the next 4 weeks, rivastigmine 13.5mg patch for the next 4 weeks and then rivastigmine 18mg patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
干预措施: Rivastigmine transdermal patch (Drug)
结局指标
主要结局
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)
时间窗: Baseline and Week 24
The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.
次要结局
- Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug(Week 24)
- Change From Baseline in Disability Assessment for Dementia (DAD)(Baseline and Week 24)
- Change From Baseline in Mini-Mental State Examination (MMSE)(Baseline and Week 24)
- Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)(Week 4, 8, 12, 16, 20, 24)
- Change From Baseline in Modified Crichton Scale(Baseline and Week 4, 8, 12, 16, 20, 24)
- Formulation usability questionnaire(Week 24)