NCT00804271已完成3 期
Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
研究概览
简要总结
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
- •Signed informed consent prior to the initiation of any study specific procedures.
- •Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.
排除标准
- •Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
- •Intake of any medication that is contra-indicated in combination with memantine.
- •History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
- •Known or suspected history of alcoholism or drug abuse within the past 2 years.
- •Current or previous treatment with memantine or participation in an investigational study with memantine.
研究组 & 干预措施
Memantine
Other
干预措施: memantine (Drug)
结局指标
主要结局
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
时间窗: at post baseline visit
次要结局
- Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.(at a post baseline visit)
研究者
研究点 (1)
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