A Multicenter, Randomized, Open-label, Prospective Study to Estimate the add-on Effects of Memantine as Ebixa Oral Pump on Language in Moderate to Severe Alzheimer's Disease Patients Already Receiving Donepezil.
试验速览
- 阶段
- 4 期
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- AQ-WAB(Western aphasia battery)
研究概览
简要总结
This study will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe Alzheimer's disease patients who are taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in probable AD.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria
- •MMSE score equal to or less than 20
- •Brain CT or MRI scan performed within the past 12 months
- •living or having regular visit at least three times a week from caregiver
- •able to visit outpatient clinic and to perform cognitive function test
- •already taking stable dose of donepezil for 3 months prior to screening
- •subject and caregiver who signed informed consent
排除标准
- •involved in another clinical trial within 4 weeks prior to screening
- •severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure
- •bradycardia (pulse rate less than 50bpm), sick sinus syndrome
- •any laboratory finding including cognitive impairments(vitamine B12 or folic acid, syphilis, thyroid disease)
- •severe auditory or visual disturbance
- •other degenerative disease or psychosis
- •taken any drug used for the treatment of Alzheimer's disease or dementia
研究组 & 干预措施
donepezil maintain group
continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group
干预措施: donepezil (Drug)
add-on Ebixa oral pump group
Ebixa dosage titration (5mg per day for 1week, then 10mg per day for 1week, then 15mg per day for 1week, then up to 20mg per day) add-on already taking donepezil (5mg or 10mg per day)
干预措施: Ebixa (Drug)
add-on Ebixa oral pump group
Ebixa dosage titration (5mg per day for 1week, then 10mg per day for 1week, then 15mg per day for 1week, then up to 20mg per day) add-on already taking donepezil (5mg or 10mg per day)
干预措施: donepezil (Drug)
结局指标
主要结局
AQ-WAB(Western aphasia battery)
时间窗: Six months
次要结局
- ROSA (Relevant Outcome Scale for Alzheimer's Disease)(six months)
研究者
Seol-Heui Han
Professor
Konkuk University Medical Center