Clinical Evaluation of 18F-AV-1451
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 5
- 主要终点
- Flortaucipir PET Scan SUVr
研究概览
简要总结
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.
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
- 是
入选标准
- •Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
排除标准
- •Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- •Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
- •Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
- •Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
- •Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- •Have a history of relevant severe drug allergy or hypersensitivity
- •Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
- •Are patients with current clinically significant unstable medical comorbidities
- •Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
研究组 & 干预措施
Flortaucipir PET Scans
干预措施: Flortaucipir F18 (Drug)
Flortaucipir PET Scans
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Flortaucipir PET Scan SUVr
时间窗: baseline and follow-up scans
Standard Uptake Value Ratio (SUVr) using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Number of Participants With Adverse Events Related to Flortaucipir Administration
时间窗: within 48 hours of drug administration
Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency \> 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).
次要结局
未报告次要终点