The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia

Eisai Limited4 个研究点分布在 2 个国家开始时间: 2002年8月1日最近更新: 2013年5月10日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Eisai Limited
试验地点: 4
主要终点: PD patients with dementia will be screened up to 4 weeks prior to initiating dose administration. Baseline measurement on efficacy measures will be conducted at baseline, after which the first dose of study medication will be administered.

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

A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.

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: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with an established diagnosis of PD and dementia, who fulfill all of the inclusion criteria and none of the

排除标准

•listed below, will be eligible for enrolment into this study.
•Best efforts must be made on clinical grounds to exclude patients with DLB and AD. The key inclusion criteria in this respect is the onset of dementia documented to have occurred at least 1 year after the diagnosis of PD.

结局指标

主要结局

PD patients with dementia will be screened up to 4 weeks prior to initiating dose administration. Baseline measurement on efficacy measures will be conducted at baseline, after which the first dose of study medication will be administered.

次要结局

未报告次要终点

研究者

发起方

Eisai Limited

申办方类型

Industry

研究点 (4)

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