Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Study Overview
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Brief Summary
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Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers

Official Title
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Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Conditions
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Autism, Fragile-X Syndrome (FXS), Healthy Volunteers

Intervention / Treatment
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* Drug: [18F]FPEB PET imaging
* Other: Biological samples
* Other: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autistic patients<br>[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples | Drug: [18F]FPEB PET imaging<br>* PET exam<br>Other: Biological samples<br>* blood sample and urine sample<br>Other: MRI<br>* MRI exam<br>|
| Experimental: FXS patients<br>[18F]FPEB PET imaging MRI Biological samples | Drug: [18F]FPEB PET imaging<br>* PET exam<br>Other: Biological samples<br>* blood sample and urine sample<br>Other: MRI<br>* MRI exam<br>|
| Experimental: Healthy subjects<br>[18F]FPEB PET imaging MRI Biological samples | Drug: [18F]FPEB PET imaging<br>* PET exam<br>Other: Biological samples<br>* blood sample and urine sample<br>Other: MRI<br>* MRI exam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral glutaminergic activity assessed by binding potential of [18F]FPEB |  | An average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distribution volume of [18F]FPEB |  | An average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, fragile X syndrome (FXS), PET (Positron Emission Tomography), glutamate