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Glutaminergic Transmission in Autism : Molecular Imaging Exploration (TANGAU)

This study is currently recruiting participants.
Verified August 2016 by University Hospital, Tours
Sponsor:
ClinicalTrials.gov Identifier:
NCT02719951
First Posted: March 25, 2016
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Tours
  Purpose
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers

Condition Intervention Phase
Autism Fragile-X Syndrome (FXS) Healthy Volunteers Drug: [18F]FPEB PET imaging Other: Biological samples Other: MRI Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

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

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

Estimated Enrollment: 42
Study Start Date: April 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autistic patients
[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
Drug: [18F]FPEB PET imaging
PET exam
Other: Biological samples
blood sample and urine sample
Other: MRI
MRI exam
Experimental: FXS patients
[18F]FPEB PET imaging MRI Biological samples
Drug: [18F]FPEB PET imaging
PET exam
Other: Biological samples
blood sample and urine sample
Other: MRI
MRI exam
Experimental: Healthy subjects
[18F]FPEB PET imaging MRI Biological samples
Drug: [18F]FPEB PET imaging
PET exam
Other: Biological samples
blood sample and urine sample
Other: MRI
MRI exam

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719951


Contacts
Contact: Frederique Bonnet-Brilhault, PhD +33247478412
Contact: Catherine Roussel +33247479789 roussel@med.univ-tours.fr

Locations
France
CHU Tours Recruiting
Tours, France, 37044
Contact: Frederique Bonnet-Brilhault, PhD         
Contact: Catherine Roussel    +33247479789    roussel@univ-tours.fr   
Principal Investigator: Frederique Bonnet-Brilhault, PhD         
Sub-Investigator: Valerie Gissot, MD         
Sponsors and Collaborators
University Hospital, Tours
  More Information

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02719951     History of Changes
Other Study ID Numbers: PRIA 14 FBB / TANGAU
First Submitted: March 9, 2016
First Posted: March 25, 2016
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data.

Keywords provided by University Hospital, Tours:
autism
fragile X syndrome (FXS)
PET (Positron Emission Tomography)
glutamate

Additional relevant MeSH terms:
Autistic Disorder
Fragile X Syndrome
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System