Glutaminergic Transmission in Autism : Molecular Imaging Exploration (TANGAU)

June 6, 2019 updated by: University Hospital, Tours
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

November 15, 2018

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (ESTIMATE)

March 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIA 14 FBB / TANGAU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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