NCT00443417已完成2 期
Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 188
- 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 find optimistic dose and 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
- •Age range : 50 ~ 85 years
- •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 10 to 26
- •AChEI or memantine was discontinued at least 3 months prior to screening
排除标准
- •Patient in mild cognitive impairment (MCI; CDR-SB <2.5)
- •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
4
Active Comparator
400mg qd
干预措施: SK-PC-B70M (Drug)
1
Placebo Comparator
干预措施: SK-PC-B70M (Drug)
2
Active Comparator
200mg qd
干预措施: SK-PC-B70M (Drug)
3
Active Comparator
200mg bid
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)
- QOL-AD(Quality of Life in Alzheimer's Disease)(10 minutes)
- Delayed Word-Recall Task(5 minute)
- Symbol Digit Modalities Test(5 minutes)
- Digit Backward(5 minutes)
- Maze Task(3 minutes)
- Digit Cancellation Task(5 minutes)
- Verbal Fluency-Categories(1 minutes)
- Concentration / Distractibility(1 minutes)
- GDS(10 minutes)
研究者
研究点 (1)
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