NCT01023425已完成不适用
Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
研究概览
简要总结
To compare the clinical efficacy of donepezil between the naive group and the switching group.
详细描述
The purposes of this study are:
- to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
- to help to clinicians in choosing the best treatment
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
- •Korean version Mini-Mental State Examination scores between 10 and 26
- •History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- •A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
排除标准
- •they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- •Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- •Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- •Clinically active cerebrovascular disease; History of seizure disorder
- •Other physical conditions that required acute treatment.
研究组 & 干预措施
switching group
Experimental
switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately
干预措施: donepezil (Drug)
naive group
Experimental
naive patients with AD who initiated therapy with donepezil
干预措施: donepezil (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
时间窗: 13 weeks, 26 weeks, 39 weeks, 52 weeks
次要结局
- Seoul Activities of Daily Living (S-ADL)(13 weeks, 26 weeks, 39 weeks, 52 weeks)
- Seoul-Instrumental Activities of Daily Living (S-IADL)(13 weeks, 26 weeks, 39 weeks, 52 weeks)
- Korean Neuropsychiatric Inventory (K-NPI)(13 weeks, 26 weeks, 39 weeks, 52 weeks)
研究者
Doh Kwan Kim
Professor
Samsung Medical Center
研究点 (1)
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