An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Qualitative Amyloid Image Assessment
研究概览
简要总结
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (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
- 是
入选标准
- 未提供
排除标准
- •Have a history or current diagnosis of other neurologic disease
- •Have had or currently have a diagnosis of other neurodegenerative disease
- •Have participated in experimental therapy targeted to amyloid plaque
研究组 & 干预措施
AD subjects
干预措施: florbetapir F 18 (Drug)
MCI Subjects
MCI (mild cognitive impairment)
干预措施: florbetapir F 18 (Drug)
Healthy controls
干预措施: florbetapir F 18 (Drug)
结局指标
主要结局
Qualitative Amyloid Image Assessment
时间窗: 50-60 min after injection
Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Mean Cortical to Cerebellum SUVR
时间窗: 50-60 min after injection
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
次要结局
- Proportion of Positive Florbetapir-PET Scans(50-60 min after injection)