A Multicenter, Randomized, Open-label, Prospective Trial to Evaluate the Safety and Tolerability of Donepezil 23 mg With or Without Intermediate Dose Titration in Patients With Alzheimer's Disease Taking Donepezil Hydrochloride 10 mg
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with Alzheimer's disease. Investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.
详细描述
High dose of donepezil is currently prescribed for patients with Alzheimer's disease who showed poor response in lower dose, however the side effect profiles according to dose titration method were not clarified yet. This study aims to confirm which titration method would show better safeties and tolerabilities in the high dose donepezil treatment. Investigators include patients with moderate to severe dementia who were diagnosed as probable Alzheimer's disease and treated with donepezil 10mg at least 3 months before the study. The study duration is for 12 weeks and the titration duration is the first 4 weeks of the study. Investigators evaluate the side effects profiles and vital signs at every 4 weeks and measure blood laboratory tests at screening and the last visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria
- •probable Alzheimer's disease dementia according to National Institute on Aging-Alzheimer's Association (NIAAA) criteria
- •Mini-Mental State Examination (MMSE) score of 20 or less
- •General Deterioration Scale (GDS) score of 4 or more / Clinical Dementia Rating (CDR) score of 2 or more
- •stable dose of 10mg donepezil at least 3 months before screening
- •caregiver who can come together at every visit and give informations about side effects profiles should exist
- •patients and caregivers accepted the study
排除标准
- •patients receiving other concomitant acetylcholinesterase inhibitor
- •uncontrolled psychiatric disorders
- •drug overuse or alcohol abuse history within 5 years
- •significant uncontrolled or active medical conditions
- •uncontrolled epilepsy
- •patients who cannot come at scheduled visits
研究组 & 干预措施
donepezil 15mg titration
donepezil 15mg during the first 4 weeks before escalation to 23mg
干预措施: donepezil (Drug)
donepezil 10mg & 23 mg alternating
alternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg
干预措施: donepezil (Drug)
no titration of donepezil
no titration and direct escalation to 23mg donepezil
干预措施: donepezil (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: Change from baseline at 4 week
adverse events (nausea, vomiting, diarrhea, anorexia, abdominal pain, headache and other unpredicted adverse events)are asked and assessed using 3 grade scale (mild, moderate, severe)
次要结局
- blood WBC(12 week)
- blood Creatinine(12 week)
- drug compliance (counting of residual drug)(4 week, 8 week, 12 week)
- heart rate on Electrocardiography (ECG)(12 week)
- blood sodium(12 week)
- blood potassium(12 week)
- weight loss(4 week, 8 week, 12 week)
- blood BUN(12 week)
- blood AST/ALT(12 week)
研究者
Jae-Hong Lee
Principal investigator
Asan Medical Center