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临床试验/EUCTR2015-003705-42-NL
EUCTR2015-003705-42-NL进行中(未招募)1 期

ongitudinal imaging of tau accumulation in the preclinical stages of AD - LUNAR

VU University Medical Center0 个研究点目标入组 50 人开始时间: 2015年10月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

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

  • - Clinically diagnosed with 'subjective cognitive decline' after the standardized dementia screening performed at the VUmc Alzheimer Center
  • - At least 50 years of age
  • - Enrollment in the FIAD cohort (protocol nr 13-256)
  • - Have received or will receive a [18F]Florbetapir PET scan 90 days before or after the [18F]AV-1451 PET scan
  • 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 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • - Has contraindications for MRI scanning and therefore can not receive brain MRI
  • - Has evidence for structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan
  • - Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must not be pregnant or breast feeding at screening.
  • - 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.;
  • - Has ever participated in an experimental study with a tau targeting agent, unless it can be documented that the subject received only placebo during the course of the trial;
  • - Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv
  • - Has a history of severe traumatic brain injury (TBI)

研究者

发起方
VU University Medical Center

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