NCT03441516Unknown4 期
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study
Yuhan Corporation6 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2018年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 79
- 试验地点
- 6
- 主要终点
- ADAS-cog
研究概览
简要总结
This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (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
- •50 - 90 years of age
- •Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- •A diagnosis of probable Alzheimer's Disease, or mild to moderate AD determined by NIA-AA (National Institute on Aging and the Alzheimer's Association) criteria
- •K-MMSE score of 12 - 26
- •Global Clinical Dementia Rating (CDR) score of 0.5 - 2
- •Patient taking 10 mg of donepezil per day for a minimum of 12 weeks with a stable dose, not taking other brain pills including choline alfoscerate for at least 2 weeks from screening. Drugs that are likely to affect cognition are permissible if the dose is regular and stable for at least 2 weeks before screening and if the treatment continues for the duration of the trial.
排除标准
- •Subject suspected of dementia due to organic causes other than Alzheimer's type dementia
- •Other degenerative brain diseases or major mental illnesses such as major depression, bipolar disorder, alcohol/substance abuse or dependence, delirium
- •Hypersensitive to choline alfoscerate, donepezil hydrochloride, or piperidine derivatives or the components of this drug
- •Subject who has contraindications as listed in the SPC of choline alfoscerate or donepezil hydrochloride
- •Other than the above who is deemed to be ineligible to participate in the trial
研究组 & 干预措施
Alfoatirin® Tab. + Aripezil® Tab.
Experimental
Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks
干预措施: Alfoatirin® Tab. + Aripezil® Tab. (Drug)
Aripezil® Tab.
Active Comparator
Donepezil 10mg qd for 24 weeks
干预措施: Aripezil® Tab. (Drug)
结局指标
主要结局
ADAS-cog
时间窗: At 24 weeks
To evaluate cognitive function
次要结局
- K-MMSE (Korean version of Mini-Mental State Examination)(At 12 and 24 weeks)
- FAB (Frontal Assessment Battery)(At 12 and 24 weeks)
- ADAS-cog(At 12 weeks)
- CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)(At 12 and 24 weeks)
- S-IADL (Seoul-Instrumental Activities of Daily Living)(At 12 and 24 weeks)
- Changes in brain metabolism by F-18 FDG brain PET(At 24 weeks)
研究者
研究点 (6)
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