Changes of Cognitive Function in Patients With Mild to Moderate Alzheimer's Disease Associated With or Without White Matter Changes After Rivastigmine Patch Therapy - Multi-center, Prospective, Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 16
- 主要终点
- The changes of cognitive function as measured by ADAS-Cog
研究概览
简要总结
The purpose of this study is to evaluate and compare the changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated with and without white matter changes after rivastigmine patch therapy.
详细描述
Acetylcholinesterase inhibitors (AChEIs) increase the amount acetylcholine at ACh receptors within the brain, and are the primary medications used to treat AD. Alzheimer's disease patients are frequently associated with mild or moderate white matter changes on MR imaging. The impact of whiter matter changes on the efficacy of cognition, functional abilities, behavioral and psychiatric symptoms and caregiver burden for probable Alzheimer's disease is not well known. There are very few studies for the efficacy of rivastigmine between the patients with mild to moderate Alzheimer's disease associated with or without vascular risk factors.
Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes. Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimer's and vascular pathologies contributing to dementia, providing additive treatment effects in patients suffering from both conditions concurrently. To our Knowledge, there was no study or clinical trial to compare the changes of cognitive function, ADL, BPSD and caregiver burden in two groups of patient with Alzheimer's disease associated with or without white matter changes after rivastigmine transdermal patch therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AD in NINCDS-ADRDA criteria, mild to moderate
- •probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
- •MMSE score : 10 to 26 at screening
- •Hachinski scores ≤ 4
- •No clinically significant laboratory abnormalities, such as thyroid disease, vitamine B12 deficiency or folic acid deficiency
排除标准
- •Current evidence of history of neurological, psychiatric and other illness that could contribute to dementia
- •Subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months
- •History of cancer within the last 5 years
- •Subjects with evidence or history of clinically significant allergic reaction to AchEI or drugs
- •Subjects who had significant visual or hearing difficulties
研究组 & 干预措施
without white matter change
干预措施: rivastigmine patch (Drug)
with white matter change group
干预措施: rivastigmine patch (Drug)
结局指标
主要结局
The changes of cognitive function as measured by ADAS-Cog
时间窗: 24 weeks
次要结局
- Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)(24 weeks)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)(24 weeks)
- Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)(24 weeks)
- MMSE (Mini-Mental State Examination)(24 weeks)
- Caregiver burden scale(24 weeks)
- Adverse events(24 weeks)
研究者
Kyungil Park
Assistant professor
Dong-A University