NCT00776347已完成不适用
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
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
- 24
- 试验地点
- 1
- 主要终点
- FDG-PET
研究概览
简要总结
The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DLB patients:
- •who fulfill the diagnostic criteria of DLB
- •60 to 85 years old
- •right-handed
- •Clinical Dementia Rating (CDR) ≧ 0.5
- •Mini Mental State Examination (MMSE) score from 10 to 26
- •Normal Controls:
- •who are independent
- •who have no subjective or objective cognitive impairment
- •60 to 85 years old
- •right-handed
- •MMSE score over 24
排除标准
- •DLB patients:
- •who have diabetes mellitus
- •who have pathological change on MRI other than brain atrophy
- •who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
- •who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
- •who have severe digestive ulcus
- •who have severe bronchitic asthma or obstructive lung disease
- •who have no caregiver who knows patient's condition well
- •Normal Controls:
- •who have diabetes mellitus
- •who have taken donepezil before
- •who have abnormal findings on MRI
- •who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function
研究组 & 干预措施
donepezil
Experimental
干预措施: Donepezil (Drug)
结局指标
主要结局
FDG-PET
时间窗: 14 weeks
次要结局
- Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver(14 weeks)
研究者
研究点 (1)
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