Test-retest Reproducibility of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Alzheimer's Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean Cortical to Cerebellum SUVR
研究概览
简要总结
This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).
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
- 35 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
- 未提供
研究组 & 干预措施
AD Subjects
Two bolus IV injections followed by brain PET scan up to 4 weeks apart
干预措施: florbetapir F 18 (Drug)
AD Subjects: Slow vs. Fast Bolus
Two bolus IV injections followed by a brain PET scan up to 4 weeks apart.
The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
干预措施: florbetapir F 18 (Drug)
Healthy controls
Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart
干预措施: florbetapir F 18 (Drug)
结局指标
主要结局
Mean Cortical to Cerebellum SUVR
时间窗: 50-70 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
未报告次要终点