NCT01023867已完成不适用
Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
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
- 88
- 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 patients with Alzheimer's disease and Mixed Dementia.
详细描述
The purposes of this study are:
- to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
- to help to clinicians in choosing the best treatment for patients with mixed dementia
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 and Mixed Dementia 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
Alzheimer's disease group
Experimental
Patients with Alzheimer's disease treated donepezil
干预措施: donepezil (Drug)
Mixed Dementia group
Experimental
Patients with Mixed Dementia treated 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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