NCT02787746已完成4 期
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
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
- 241
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events (AEs)
研究概览
简要总结
This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.
详细描述
This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.
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
- •Patients between 50 and 85 years of age.
- •Patients newly diagnosed as probable AD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and National Institute of Neurologic and Communicative Disorders and Stroke-AD and Related Disorders Association (NINCDS-ADRDA) criteria; Mild to moderate AD with Mini-Mental State Examination (MMSE) 10-24, modified Hachinski ischaemic scale (MHIS)≤4, Activity of daily life scale (ADL)≥23, and Hamilton Depression Scale (HAMD) <
- •MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2 within 6 months prior to the screening).
- •5mg daily of Donepezil for at least four weeks before the screening.
- •Patient with exclusive caregiver.
- •Patient should be ambulatory or ambulatory aided by a walker or cane.
- •With good eyesight and hearing, can cooperate with the examination and treatment.
排除标准
- •Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
- •Patients with type I diabetes, obstructive lung disease or asthma, vitamin B12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart failure, myocardial infarction, sick sinus syndrome, II-III degree atrioventricular block or heart rate<50 beats/minute [bpm]).
- •Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
- •Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
- •Patients with a history of alcohol dependence and drug abuse.
- •Patients with known hypersensitivity to medicines or foods;
- •Patients taking anticholinergic agents or antihistaminic agents;
- •Patients who had been hospitalized continuously for more than 3 months before the screening.
研究组 & 干预措施
donepezil
Other
This is a multi-center single-arm study, which assess the safety and efficacy of donepezil in mild to moderate Alzheimer's disease in China.
干预措施: Donepezil (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs)
时间窗: 20 weeks
Physical examinations such as vital signs and weight, clinical laboratory tests, and electrocardiograms (ECGs) during the 20 weeks.
次要结局
- APOE Genotype(4 weeks)
- Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil(20 weeks)
- Number of Patients Who Withdrew From the Trial Due to Adverse Events.(20 weeks)
- Changes in Mini-Mental State Examination Scores From Baseline(Baseline, 4, 20 weeks)
- Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline(Baseline, 4, 20 weeks)
研究者
Jianping Jia
Director of Neurology Department
Beijing Friendship Hospital
研究点 (1)
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