Flortaucipir (18F) PET Imaging in the BIOCARD Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Quantitative Evaluation of Scan Results
研究概览
简要总结
This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females that have provided consent and are currently enrolled in BIOCARD study
- •Ability to tolerate PET scan procedures
- •Ability to provide informed consent for study procedures
排除标准
- •Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator
- •Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.
- •Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
- •Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
- •Has hypersensitivity to flortaucipir
- •Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
- •Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit.
- •Is unsuitable for a study of this type in the opinion of the investigator.
研究组 & 干预措施
Amyloid Positive
Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
干预措施: Flortaucipir F18 (Drug)
Amyloid Positive
Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
干预措施: Brain PET scan (Procedure)
Amyloid Negative
Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
干预措施: Flortaucipir F18 (Drug)
Amyloid Negative
Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Quantitative Evaluation of Scan Results
时间窗: 75 minutes post dose administration
Standard Uptake Value Ratio (SUVr) by amyloid status 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.
Qualitative Evaluation of Scan Results
时间窗: Baseline scan
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
次要结局
未报告次要终点