Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Novartis Pharmaceuticals75 个研究点分布在 11 个国家目标入组 1,040 人开始时间: 2003年11月最近更新: 2017年10月13日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 1,040
试验地点: 75
主要终点: Change in cognition from baseline at week 24

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable 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: Double

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

•Diagnosis of dementia of the Alzheimer's type
•Males, and females who are surgically sterile or one year postmenopausal
•A primary caregiver willing to accept responsibility for supervising the treatment

排除标准

•Any condition (other than Alzheimer's) that could explain patient's dementia
•An advanced, severe or unstable disease that may put the patient at special risk
•Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

结局指标

主要结局

Change in cognition from baseline at week 24

Global clinical impression of change from baseline at week 24

次要结局

Change from baseline at week 24 in activities of daily living
Change from baseline at week 24 in global cognitive testing
Change from baseline at week 24 in behavioral symptoms
Change from baseline at week 24 in executive function
Change from baseline at week 24 in attention

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

研究点 (75)

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