A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Number of Participants With Medication Continuation
研究概览
简要总结
The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.
详细描述
To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV.
- •Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.
- •Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution.
- •Outpatients in their own home.
排除标准
- •Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment.
- •Known hypersensitivity to donepezil or piperidine derivatives.
- •Involvement in any other investigational drug clinical trail during the preceding 12 weeks.
研究组 & 干预措施
Intensive adherence instruction
Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
干预措施: Intensive adherence instruction (Behavioral)
Control
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
干预措施: Control (Behavioral)
结局指标
主要结局
Number of Participants With Medication Continuation
时间窗: 48 weeks
Number of Participants who Continue the Medication for 48 weeks
次要结局
- Reasons for Discontinuation(48 weeks)
- Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics(48 weeks)
- Adverse Events(Week 2, 12, 24, 48)
研究者
Tetsumasa Kamei
Hospital Director
Mirai Iryo Research Center, Inc.