NCT00234637已完成4 期
An Open-label Study to Evaluate the Efficacy and Safety of add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
研究概览
简要总结
This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
- •Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
- •Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine
排除标准
- •Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial
结局指标
主要结局
The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
次要结局
- Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
- Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
- Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
- Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline
研究者
研究点 (2)
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