跳至主要内容
临床试验/EUCTR2018-004466-34-NL
EUCTR2018-004466-34-NL进行中(未招募)1 期

Tau PET imaging in cognitively normal elderly subjects: A twin approach - Tau Twin

Amsterdam UMC VUmc0 个研究点目标入组 80 人开始时间: 2018年12月19日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion in PreclinAD study (2014.210) and a subject must be older than 60 years and have received an [18F]flutemetamol amyloid PET scan and/or have a known amyloid status obtained from CSF.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 70

排除标准

  • 1.Has contra indications for MRI scanning and therefore has not received brain MRI;
  • 2.Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan;
  • 4.Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc.;
  • 5.Has ever participated in an experimental study with a tau agent, unless it can be documented that the subject received only placebo during the course of the trial;
  • 6.Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives or when total yearly radiation exposure exceeds 16.1 mSv for female and 22.4 mSv for male participants[25].
  • 7.Has a history of severe traumatic brain injury (TBI).

研究者

发起方
Amsterdam UMC VUmc

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