18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Flortaucipir Visual Read as CTE Biomarker
研究概览
简要总结
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
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
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols
- •Can tolerate up to two PET imaging sessions
- •Have the ability to provide informed consent for study procedures
排除标准
- •Claustrophobia
- •Current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG
- •History of risk factors for Torsades de Pointes or are taking drugs known to cause QT-prolongation
- •Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results
- •Have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study PET imaging sessions
研究组 & 干预措施
High Risk of CTE
Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
干预措施: florbetapir F 18 (Drug)
High Risk of CTE
Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
干预措施: Flortaucipir F18 (Drug)
Control
Flortaucipir PET scans in former non-contact athletes
干预措施: florbetapir F 18 (Drug)
Control
Flortaucipir PET scans in former non-contact athletes
干预措施: Flortaucipir F18 (Drug)
结局指标
主要结局
Flortaucipir Visual Read as CTE Biomarker
时间窗: Baseline scan
Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
时间窗: baseline scan
The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group.
次要结局
未报告次要终点