A Phase 1, Randomized, Placebo-Controlled, Double Blind, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)
研究概览
简要总结
The purpose of the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese males or females of non childbearing potential, age > or = 50
- •Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
- •National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- •Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- •Mini-mental status exam score of 16-26 inclusive
- •Rosen-Modified Hachinski Ischemia Score of < or = 4
排除标准
- •Diagnosis or history of other demential 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
PF-04360365 8.5 mg/kg
干预措施: PF-04360365 8.5 mg/kg (Biological)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)
时间窗: 12 months
Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)
时间窗: 12 months
次要结局
- Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.(12 months)