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Completed

NCT Number: NCT02719951

Glutaminergic Transmission in Autism : Molecular Imaging Exploration

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

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fragile X Syndrome Fragile-X Syndrome (FXS) Genetic Diseases, Inborn Genetic Diseases, X-Linked Healthy Volunteers Heredodegenerative Disorders, Nervous System Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Sex Chromosome Disorders X-Linked Intellectual Disability

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU Tours

Tours, 37044, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

[18F]FPEB PET imaging

Drug

PET exam

Biological Samples

Other

blood sample and urine sample

MRI

Other

MRI exam

Primary outcomes

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

    Time frame: An average of 3 years

Secondary outcomes

  1. distribution volume of [18F]FPEB

    Time frame: An average of 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: TANGAU

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 25, 2016
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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