NCT02795780已完成2 期
An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05
Avid Radiopharmaceuticals22 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2016年8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
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 22
- 主要终点
- Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status
研究概览
简要总结
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake 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
- 否
入选标准
- •Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study
排除标准
- •Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), 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
- •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
- •Have received or participated in a trial with investigational medications in the past 30 days
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: PET Scan (Procedure)
结局指标
主要结局
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status
时间窗: 18 months
Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.
次要结局
未报告次要终点
研究者
研究点 (22)
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