NCT01005862已完成1 期
A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
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
- 17
- 试验地点
- 1
- 主要终点
- Fractional Clearance rate of ABeta peptide in CSF
研究概览
简要总结
The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
- •For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- •Mini-mental status exam score greater than or equal to 20
- •Rosen-Modified Hachinski Ischemia Score of < or = 4
- •On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment
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
Experimental
干预措施: PF-04360365 (Biological)
Placebo
Placebo Comparator
single dose administered intravenously
干预措施: Placebo (Drug)
结局指标
主要结局
Fractional Clearance rate of ABeta peptide in CSF
时间窗: 36 hours
次要结局
- Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion(36 hours)
- PF-04360365 concentrations and ABETA concentrations in plasma and CSF(36 hours)
- Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration(36 hours)
- Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI(6 months)
研究者
研究点 (1)
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