Glutaminergic Transmission in Autism : Molecular Imaging Exploration

NCT02719951 | Completed Phase 1 DMC

• 1 other identifier: PRIA 14 FBB / TANGAU
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism; Fragile-X Syndrome (FXS); Healthy Volunteers

Keywords

autism; fragile X syndrome (FXS); PET (Positron Emission Tomography); glutamate

Outcome Measures

Primary Outcomes (1)

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

  An average of 3 years

Secondary Outcomes (1)

• distribution volume of [18F]FPEB

  An average of 3 years

Study Arms (3)

autistic patients

EXPERIMENTAL

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

Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI

FXS patients

EXPERIMENTAL

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

Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI

Healthy subjects

EXPERIMENTAL

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

Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI

Interventions

[18F]FPEB PET imaging DRUG

PET exam

FXS patients; Healthy subjects; autistic patients

Biological samples OTHER

blood sample and urine sample

FXS patients; Healthy subjects; autistic patients

MRI OTHER

MRI exam

FXS patients; Healthy subjects; autistic patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

CHU Tours

Tours, 37044, France

Location

Related Publications (1)

• Dupont AC, Serriere S, Barantin L, Vercouillie J, Tauber C, Gissot V, Bodard S, Chicheri G, Chalon S, Bonnet-Brilhault PF, Santiago-Ribeiro PM, Arlicot N. Study of influence of the glutamatergic concentration of [18F]FPEB binding to metabotropic glutamate receptor subtype 5 with N-acetylcysteine challenge in rats and SRM/PET study in human healthy volunteers. Transl Psychiatry. 2021 Jan 20;11(1):66. doi: 10.1038/s41398-020-01152-2.

  PMID: 33473111 RESULT

MeSH Terms

Conditions

Autistic Disorder; Fragile X Syndrome

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 25, 2016
• Study Start: April 1, 2016
• Primary Completion: November 15, 2018
• Study Completion: May 1, 2019
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)