NCT00097916已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease
Forest Laboratories18 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 18
- 主要终点
- Neuropsychiatric Inventory
研究概览
简要总结
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI
- •Stable dose of donepezil for 3 months
排除标准
- •Other evidence of psychiatric disorders
- •Oncologic diagnosis
- •Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
结局指标
主要结局
Neuropsychiatric Inventory
次要结局
- Cohen Mansfield Agitation Inventory
- Clinical Global Impression Scale
- ADCS-ADL
- Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
研究者
研究点 (18)
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