NCT01656525已完成1 期
A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Pharmacokinetic parameters of Gantenerumab in plasma
研究概览
简要总结
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
- •Meet DSM-IV criteria for Dementia of the Alzheimer type
- •MMSE score : 16 to 26 etc.
排除标准
- •Meet the exclusion criteria of MRI at screening.
- •A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.
研究组 & 干预措施
1
Experimental
干预措施: Gantenerumab (Drug)
2
Experimental
干预措施: Gantenerumab (Drug)
3
Experimental
干预措施: Gantenerumab (Drug)
4
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic parameters of Gantenerumab in plasma
时间窗: 36 weeks
Number of participants with Adverse Events
时间窗: 36 weeks
CSF/plasma ratios of Gantenerumab.
时间窗: Baseline, Day183
次要结局
- Change from baseline in plasma and CSF tau(Baseline,Day183)
- Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).(Baseline,Day85, 197, 253)
- Change from baseline in plasma Abeta(Baseline,Day183)
研究者
研究点 (5)
Loading locations...
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