EUCTR2020-002672-12-NL进行中(未招募)1 期
Frontotemporal dementia Imaging of Neuroinflammation, Degeneration and Microglia-Related Effects - FIND-MORE
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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