18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Relationship Between Clinical Presentation and Tau Deposition (MMSE)
研究概览
简要总结
This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.
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
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TBI Subjects
- •Subjects that have consented and are currently enrolled in either Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084
- •History of having sustained a TBI < 6 weeks prior to enrollment
- •Can tolerate PET and MRI scan procedures
- •Control Subjects
- •MMSE ≥ 28
- •No significant history of cognitive impairment
- •No prior history of TBI
- •Can tolerate PET and MRI scan procedures
排除标准
- •Have behavior dysfunction that is likely to interfere with imaging
- •Are claustrophobic or otherwise unable to tolerate the imaging procedure
- •Have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ECG
- •A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
- •Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- •Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- •Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the 18F-AV-1451 imaging session
- •Have current alcohol dependence or alcohol dependence within the past 1 year
- •Are currently participating in another interventional clinical trial
- •Have evidence of a penetrating brain injury
- •Have participated in contact sports in college or after high school age
研究组 & 干预措施
TBI Subjects
Subjects with history of recent subacute Traumatic Brain Injury (TBI) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451 2 to 6 weeks following injury. They will return for a follow-up injection approximately 6 months following injury.
干预措施: 18F-AV-1451 (Drug)
Control
Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451.
干预措施: 18F-AV-1451 (Drug)
结局指标
主要结局
Relationship Between Clinical Presentation and Tau Deposition (MMSE)
时间窗: 75-105 minutes postinjection
The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).
TBI Biomarker Analysis
时间窗: 75-105 minutes postinjection
18F-AV-1451 uptake will be compared in subjects with TBI and controls.
Change in tau deposition over time
时间窗: 6 months
Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.
Relationship Between Clinical Presentation and Tau Deposition (BIS-11)
时间窗: 75-105 minutes postinjection
The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)
次要结局
未报告次要终点