跳至主要内容
临床试验/NCT02414282
NCT02414282已完成不适用

F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction Due to Alzheimer Disease

Tammie L. S. Benzinger, MD, PhD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
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

This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with Progressive Posterior Cortical Dysfunction (PPCD) and logopenic variant primary progressive aphasia (lvPPA). The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female participants, at least 45 years of age.
  • Clinical diagnosis of PPCD.
  • 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 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 high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
  • 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

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

发起方
Tammie L. S. Benzinger, MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tammie L. S. Benzinger, MD, PhD

Professor of Radiology & Neurological Surgery

Washington University School of Medicine

研究点 (1)

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