Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 23
- 主要终点
- Sensitivity Analysis in All Autopsy Population
研究概览
简要总结
This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims:
- To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
- To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are enrolled in this study if they:
- •Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
- •Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
- •Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
- •Reconfirm their consent to a research brain autopsy, if required by the IRB.
排除标准
- 未提供
结局指标
主要结局
Sensitivity Analysis in All Autopsy Population
时间窗: at autopsy within 24 months of florbetapir PET scan
Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Specificity Analysis in All Autopsy Population
时间窗: at autopsy within 24 months of florbetapir PET scan
Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Correlation of Florbetapir-PET Image and Amyloid Plaque Density
时间窗: at autopsy within 24 months of florbetapir PET scan
Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
次要结局
- Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan(at autopsy within 12 months of florbetapir PET scan)
- Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan(at autopsy within 12 months of florbetapir PET scan)