NCT01249196已完成3 期
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
- •MRI within the last 12 months consistent with a diagnosis of AD
- •MMSE score of 10 to 26 and CDR of 1 or 2
- •AChEI or memantine was not taken at least 3 months prior to screening
排除标准
- •Other central nervous disease
- •Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
- •T.I.A or Major infarction within the last 12 months
- •Any serious disorder that could limit the ability of the patient to participate in the study
- •COPD or asthma
- •Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: SK-PC-B70M (Drug)
SK-PC-B70M 200mg bid
Experimental
干预措施: SK-PC-B70M (Drug)
SK-PC-B70M 300mg bid
Experimental
干预措施: SK-PC-B70M (Drug)
Donepezil
Other
干预措施: SK-PC-B70M (Drug)
结局指标
主要结局
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
时间窗: 30 minutes
次要结局
- MMSE (Mini Mental State Examination)(10 minutes)
- CDR-SB (Clinical Dementia Rating Sum of Box)(20 minutes)
- CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)(45 minutes)
研究者
研究点 (1)
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