跳至主要内容
临床试验/EUCTR2020-002672-12-NL
EUCTR2020-002672-12-NL进行中(未招募)1 期

Frontotemporal dementia Imaging of Neuroinflammation, Degeneration and Microglia-Related Effects - FIND-MORE

Erasmus Medical Center0 个研究点目标入组 32 人开始时间: 2020年10月8日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
32

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

  • - Able to tolerate the [18F]DPA-714 PET-MRI scan procedures and to make an informed decision to participate in this study
  • - Symptomatic patients must meet clinical criteria for FTD clinical syndromes
  • - Presymptomatic individuals and healthy controls must show no objective evidence of cognitive impairment
  • 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 27
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • - Has contraindications for MRI scanning, e.g. metal objects in the body, claustrophobia
  • - Has evidence of structural brain abnormalities that are likely to interfere with the interpretation of PET scan
  • - Has one or more comorbidities that may interfere with the outcomes of the study (e.g. significant immune disease, neurological disease, CNS malignancy)
  • - Has a history of moderate or severe traumatic brain injury
  • - Has made use of immunomodulatory or immunosuppressive therapy in the 3 months prior to the scan
  • - Has any disease or uses medication that may compromise the function of the body systems and could interfere with the metabolism of the radiotracer or the interpretation of the results
  • - Has an unstable medical condition
  • - Is pregnant or breastfeeding
  • - Has a history of severe drug allergy or hypersensitivity
  • - Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when the total yearly radiation exposure exceeds 10 mSv if participating in this protocol
  • - Is a low-affinity binder for the tracer based on the rs6971 TSPO polymorphism
  • - Has a present or past history of alcohol and/or drug abuse
  • - Makes use of benzodiazepines and is not able to suspend their use during the week prior to the PET scan

研究者

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