A Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The Number of Abnormal Blinded Visual PET Image Interpretations.
研究概览
简要总结
Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject was enrolled in prior Study GE067-
- •The subject died on or before 10 June
- •The subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis.
排除标准
- •Not Applicable
结局指标
主要结局
The Number of Abnormal Blinded Visual PET Image Interpretations.
时间窗: Brain images will be assessed up to 1 year post subject's death.
Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans
时间窗: Brain images will be assessed up to 1 year post subject's death.
Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.
次要结局
- Number of Blinded Visual PET Image Interpretations(Brain images will be assessed up to 1 year post subject's death.)
- Specificity Percentage of Blinded Visual PET Image Interpretations(Brain images will be assessed up to 1 year post subject's death.)