NCT02707978撤回2 期
F 18 T807 Tau PET Imaging of Frontotemporal Dementia
Tammie L. S. Benzinger, MD, PhD1 个研究点 分布在 1 个国家开始时间: 2017年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
研究概览
简要总结
The purpose of this research study is to evaluate tau distribution in the brain of subjects with: FTD caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic FTD, normal controls.
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
- 否
入选标准
- •Male or female participants, at least 18 years of age.
- •Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation known to cause FTD (with or without symptoms); or a normal control.
- •Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
- •Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of T807 drug administration.
排除标准
- •Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- •Is deemed likely unable to perform the imaging procedures for any reason.
- •Has a history of Torsades de Pointes or is taking medications known to prolong QT interval. To determine who will be excluded from this study based on this criterion, we will review participant's medical history and current medications at time of screening. Participants will be excluded from the study if any of the following restricted medications are being taken:
- •Disopyramide
- •Dofetilide
- •Ibutilide
- •Procainamide
- •Quinidine
- •Has hypersensitivity to F 18 T807 or any of its excipients.
- •Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- •Severe claustrophobia.
- •Currently pregnant or breast-feeding.
- •For those electing to undergo the optional lumbar puncture: on
- •anticoagulant of any form prior to lumbar puncture.
研究组 & 干预措施
Experimental F 18 T807
Experimental
干预措施: F 18 T807 (Drug)
结局指标
主要结局
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Tammie L. S. Benzinger, MD, PhD
Associate Professor of Radiology and Neurological Surgery
Washington University School of Medicine
研究点 (1)
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