EUCTR2018-001584-23-FR进行中（未招募）1 期
Microglial Activation in Narcolepsy Type 1: Positron Emission Tomography (PET) Study in [18F] DPA-714 - Narcoglie
niversity Hospital of Montpellier0 个研究点目标入组 30 人开始时间: 2018年8月27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
- 30
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
- •Narcoleptic patients Inclusion Criteria :
- •- Clinical diagnosis of NT1 according to International Classification of Sleep Disorders, 3rd Edition (AASM: American Academy of Sleep Medicine, 2014), with beginning of symptoma since 2 years top (somnolence and/or cataplexy)
- •- With or without psychostimulant treatment for the pathology
- •Control patients Inclusion Criteria :
- •- Sleep disorder without objectification of narcolepsy or hypersomnia and without any inflammatory pathology.
- •Non-specific Inclusion Criteria :
- •- Age over 18
- •- Absence of contraindication to the performance of PET [18F] DPA-714
- •- Absence of immunomodulatory or anti-inflammatory treatment
- •- Subjects having given their written and informed consent for this study
- •- Subjects speaking and including French
- •- Affiliated to social security
- •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 5
排除标准
- •Exclusion Criteria (non-specific patients/control) :
- •- Refusal to perform PET Imaging in [18F] DPA-714
- •- Pregnant or lactating women
- •- Subject deprived of liberty, by judicial or administrative decision
- •- Major protected by law
- •- Subject without social security
- •- Subject in exclusion period after another protocol
- •- Refusal to participate in the protocol
- •- Contraindications to MRI
研究者
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