NCT00607308已完成1 期
A Phase 1, Randomized, Placebo-Controlled, Double Blind, Dose-Escalation, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Japanese 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
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing.
研究概览
简要总结
The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male or females of non-childbearing potential, ages 50-85
- •Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- •Mini-Mental Status Exam score of 16-26 inclusive
- •Rosen-Modified Hachinski Ischemia score < or = 4
排除标准
- •Diagnosis or history of other dementia or neurodegenerative disorders
- •Diagnosis or history of clinically significant cerebrovascular disease
- •Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- •History of autoimmune disorders
- •History of allergic or anaphylactic reactions
研究组 & 干预措施
0.1 mg/kg
Experimental
干预措施: PF-04360365 (Biological)
0.5 mg/kg
Experimental
干预措施: PF-04360365 (Biological)
1 mg/kg
Experimental
干预措施: PF-04360365 (Biological)
5 mg/kg
Experimental
干预措施: PF-04360365 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
10 mg/kg
Experimental
干预措施: PF-04360365 (Biological)
结局指标
主要结局
To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing.
时间窗: 1 year
次要结局
- To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.(1 year)
研究者
研究点 (1)
Loading locations...
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