NCT00305903已完成4 期
A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)
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
- 150
- 试验地点
- 1
- 主要终点
- Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
研究概览
简要总结
This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of probable Alzheimer's disease;
- •Have an MMSE score between 10 and 20;
- •Must be able to swallow capsule/tablet;
- •Must have a caregiver who is able to attend all study visits;
排除标准
- •Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
- •Have a current diagnosis of active, uncontrolled seizure disorder;
- •Have a history within the past year or current diagnosis of cerebrovascular disease
- •Have a current diagnosis of severe or unstable cardiovascular disease;
- •Had a myocardial infarction (MI) within the last six months;
- •Have specific respiratory, digestive, renal, or endocrine disorders;
- •Have had previous treatment with rivastigmine or memantine;
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
次要结局
- Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy
研究者
研究点 (1)
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