An Open Label, Parallel Group, Dose Comparison of Safety and Imaging Characteristics of 111 and 370 MBq (3 and 10 mCi) of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Patients With Alzheimer's Disease (AD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Florbetapir-PET Scan Quality
研究概览
简要总结
This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
111 MBq (3 mCi) AD Group
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
干预措施: florbetapir F 18 (Drug)
111 MBq (3 mCi) Control Group
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
干预措施: florbetapir F 18 (Drug)
370 MBq (10 mCi) AD Group
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
干预措施: florbetapir F 18 (Drug)
370 MBq (10 mCi) Control Group
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.
干预措施: florbetapir F 18 (Drug)
结局指标
主要结局
Florbetapir-PET Scan Quality
时间窗: 0-90 min after injection
Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).
次要结局
- Mean Cortical to Cerebellum SUVR(0-90 min after injection)