A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
研究概览
简要总结
The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.
详细描述
The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.
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 (Participant, Investigator)
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
- •The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study.
排除标准
- •Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.
研究组 & 干预措施
Memantine
干预措施: Memantine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
次要结局
未报告次要终点