A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
研究概览
简要总结
To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
- •The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
- •The subject's general health is adequate to undergo the study procedures.
排除标准
- •The subject has a contraindication for PET.
- •The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
- •The subject is unable to tolerate or cooperate with study procedures.
研究组 & 干预措施
[18F] Flutemetamol
干预措施: [18F] Flutemetamol (Drug)
结局指标
主要结局
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
时间窗: Post flutemetamol administration.
A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.
次要结局
- Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.(Post flutemetamol administration.)
- Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.(Post Flutemetamol administrations)
- Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.(Post flutemetamol administration.)