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Clinical Trials/NCT02719951
NCT02719951
Completed
Phase 1

Glutaminergic Transmission in Autism : Molecular Imaging Exploration

University Hospital, Tours1 site in 1 country27 target enrollmentApril 1, 2016

Overview

Phase
Phase 1
Intervention
Biological samples
Conditions
Autism
Sponsor
University Hospital, Tours
Enrollment
27
Locations
1
Primary Endpoint
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
May 1, 2019
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Arms & Interventions

Healthy subjects

\[18F\]FPEB PET imaging MRI Biological samples

Intervention: Biological samples

autistic patients

\[18F\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples

Intervention: [18F]FPEB PET imaging

autistic patients

\[18F\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples

Intervention: Biological samples

autistic patients

\[18F\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples

Intervention: MRI

FXS patients

\[18F\]FPEB PET imaging MRI Biological samples

Intervention: [18F]FPEB PET imaging

FXS patients

\[18F\]FPEB PET imaging MRI Biological samples

Intervention: Biological samples

FXS patients

\[18F\]FPEB PET imaging MRI Biological samples

Intervention: MRI

Healthy subjects

\[18F\]FPEB PET imaging MRI Biological samples

Intervention: [18F]FPEB PET imaging

Healthy subjects

\[18F\]FPEB PET imaging MRI Biological samples

Intervention: MRI

Outcomes

Primary Outcomes

cerebral glutaminergic activity assessed by binding potential of [18F]FPEB

Time Frame: An average of 3 years

Secondary Outcomes

  • distribution volume of [18F]FPEB(An average of 3 years)

Study Sites (1)

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