Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Phase 1

Completed

• Conditions: Autism; Healthy Volunteers; Fragile-X Syndrome (FXS)
• Interventions: Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI

• Registration Number: NCT02719951
• Lead Sponsor: University Hospital, Tours

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Study Start: 2016-04
• Primary Completion: 2018-11-15
• Status Verified: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autistic patients	[18F]FPEB PET imaging	\[18F\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
autistic patients	Biological samples	\[18F\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
autistic patients	MRI	\[18F\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
FXS patients	[18F]FPEB PET imaging	\[18F\]FPEB PET imaging MRI Biological samples
FXS patients	Biological samples	\[18F\]FPEB PET imaging MRI Biological samples
FXS patients	MRI	\[18F\]FPEB PET imaging MRI Biological samples
Healthy subjects	[18F]FPEB PET imaging	\[18F\]FPEB PET imaging MRI Biological samples
Healthy subjects	Biological samples	\[18F\]FPEB PET imaging MRI Biological samples
Healthy subjects	MRI	\[18F\]FPEB PET imaging MRI Biological samples

Primary Outcome Measures

Name	Time	Method
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB	An average of 3 years

Secondary Outcome Measures

Name	Time	Method
distribution volume of [18F]FPEB	An average of 3 years

Trial Locations

Locations (1)

CHU Tours; 🇫🇷 Tours, France