Glutaminergic Transmission in Autism : Molecular Imaging Exploration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
研究概览
简要总结
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 18 years-old and 45 years-old
- •Informed, written consent obtained from patient or his representant
- •Subject with an affiliation to French social security
- •For autistic patient : patient with diagnosis of ASD (Autistic Spectrum Disorders) following DSM-IV or DSM-5 criteria with recommended tools (ADI-R and/or ADOS)
- •For FXS patient : diagnosis of FXS and confirmation of total mutation of FMR1
排除标准
- •Contraindications to MRI
- •Excessive use of alcohol or drug, or addiction to alcohol or drug during last 6 months
- •Any unstable or uncontrolled disease, clinically significant
- •Participation to an other experimental protocol with drug or irradiant exam
- •Person under exclusion period because of previous participation to an other experimental protocol
- •Person under temporary guardianship
- •Forbidden treatments : any psychotropic treatment for 4 last weeks before PET exam and changing durably glutaminergic transmission directly or undirectly
- •For healthy subjects : adult under guardianship, medical history of central nervous system disease, medical history of attention deficit hyperactivity disorder, past or present psychiatric or neurologic disorder (MINI DSM-IV)
研究组 & 干预措施
Healthy subjects
[18F]FPEB PET imaging MRI Biological samples
干预措施: Biological samples (Other)
autistic patients
[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
干预措施: [18F]FPEB PET imaging (Drug)
autistic patients
[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
干预措施: Biological samples (Other)
autistic patients
[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
干预措施: MRI (Other)
FXS patients
[18F]FPEB PET imaging MRI Biological samples
干预措施: [18F]FPEB PET imaging (Drug)
FXS patients
[18F]FPEB PET imaging MRI Biological samples
干预措施: Biological samples (Other)
FXS patients
[18F]FPEB PET imaging MRI Biological samples
干预措施: MRI (Other)
Healthy subjects
[18F]FPEB PET imaging MRI Biological samples
干预措施: [18F]FPEB PET imaging (Drug)
Healthy subjects
[18F]FPEB PET imaging MRI Biological samples
干预措施: MRI (Other)
结局指标
主要结局
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
时间窗: An average of 3 years
次要结局
- distribution volume of [18F]FPEB(An average of 3 years)