NCT01047579已完成4 期
A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Caregiver questionnaire
研究概览
简要总结
This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
- •MMSE score of >10 and <
- •Patients who were under ChE inhibitor treatment and experienced adverse events.
- •Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.
排除标准
- •Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
- •Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
- •History of allergy to topical products containing any of the constitution of the patches.
- •Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
- •Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
- •Patients with body weight less than 40 kg.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Rivastigmine transdermal
Other
干预措施: Rivastigmine transdermal (Drug)
结局指标
主要结局
Caregiver questionnaire
时间窗: 12 weeks
次要结局
- Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)(every visit)
研究者
研究点 (2)
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