NCT02051764终止2 期
An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan
Avid Radiopharmaceuticals4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Change in Tau Deposition
研究概览
简要总结
This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a previous 18F-AV-1451 brain scan
- •Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
- •Ability to provide informed consent
排除标准
- •Current clinically significant psychiatric disease
- •Are claustrophobic
- •Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- •Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- •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 study imaging session
研究组 & 干预措施
Follow-up Flortaucipir PET Scan
Experimental
干预措施: Flortaucipir F18 (Drug)
Follow-up Flortaucipir PET Scan
Experimental
干预措施: Florbetapir F 18 (Drug)
Follow-up Flortaucipir PET Scan
Experimental
干预措施: Brain PET Scan (Procedure)
结局指标
主要结局
Change in Tau Deposition
时间窗: baseline scan and at least 6 months after baseline scan
Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
次要结局
未报告次要终点
研究者
研究点 (4)
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