NCT00733642已完成1 期
An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.
研究概览
简要总结
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
- •Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
- •MMSE score of 16-26 inclusive.
- •Rosen-Modified Hachinski Ischemia Score ≤
- •On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.
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.
- •History of allergic or anaphylactic reactions.
研究组 & 干预措施
PF-04360365 1 mg/kg
Experimental
干预措施: PF-04360365 1 mg/kg (Biological)
PF-04360365 3 mg/kg
Experimental
干预措施: PF-04360365 3 mg/kg (Biological)
PF-04360365 5 mg/kg
Experimental
干预措施: PF-04360365 5 mg/kg (Biological)
PF-04360365 10 mg/kg
Experimental
干预措施: PF-04360365 10 mg/kg (Biological)
结局指标
主要结局
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.
时间窗: 6 months
次要结局
- To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.(6 months)
- To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.(6 months)
研究者
研究点 (3)
Loading locations...
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