NCT02444637已完成4 期
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
研究概览
简要总结
Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.
In this trial, the investigators will be studying the effectiveness of Rivastigmine in subjects with AD and cerebrovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age between 50-85 years
- •Diagnosis of dementia of the Alzheimer's type according to the National Institute of Ageing-Alzheimer's Association Criteriah
- •MRI brain (with T2 or FLAIR sequences) performed within a 12 month period from time of recruitment demonstrating the presence of WMH of ≥2 on the Fazekas scale (Score range of 0-3 wherein a score of 1 indicates mild WMH, 2 indicates moderate WMH and 3 indicates severe WMH).i
- •Clinical Dementia Rating score of 1-2j
- •Mini-Mental State Examination (MMSE) scores of 12-26 inclusivek
- •English or Mandarin speaking, literate participants
排除标准
- •Severe neurological, psychiatric or systemic disease which in the opinion of the clinician could interfere with trial assessments
- •The use of any investigational drugs, new psychotropic or dopaminergic agents, cholinesterase inhibitors or anti-cholinergic agents during the 4 weeks prior to recruitment
- •Known skin allergy or previous allergic reaction to Rivastigmine patch
研究组 & 干预措施
Rivastigmine (Exelon) Patch
Experimental
For the first 4 weeks of the study, subjects will receive Rivastigmine patch 4.6mg/24 hours. Thereafter, subjects will receive Rivastigmine patch 9.5mg/24 hours.
干预措施: Rivastigmine (Drug)
结局指标
主要结局
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
时间窗: 2 Years
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(2 Years)
研究者
Dr Nagaendran Kandiah
Senior Consultant, Department of Neurology
National Neuroscience Institute
研究点 (1)
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