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Glutaminergic Transmission in Autism : Molecular Imaging Exploration (TANGAU)

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
[18F]FPEB PET imaging
Biological samples
MRI
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism focused on measuring autism, fragile X syndrome (FXS), PET (Positron Emission Tomography), glutamate

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

autistic patients

FXS patients

Healthy subjects

Arm Description

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

[18F]FPEB PET imaging MRI Biological samples

[18F]FPEB PET imaging MRI Biological samples

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

distribution volume of [18F]FPEB

Full Information

First Posted
March 9, 2016
Last Updated
June 6, 2019
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02719951
Brief Title
Glutaminergic Transmission in Autism : Molecular Imaging Exploration
Acronym
TANGAU
Official Title
Glutaminergic Transmission in Autism : Molecular Imaging Exploration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Fragile-X Syndrome (FXS), Healthy Volunteers
Keywords
autism, fragile X syndrome (FXS), PET (Positron Emission Tomography), glutamate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
autistic patients
Arm Type
Experimental
Arm Description
[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples
Arm Title
FXS patients
Arm Type
Experimental
Arm Description
[18F]FPEB PET imaging MRI Biological samples
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
[18F]FPEB PET imaging MRI Biological samples
Intervention Type
Drug
Intervention Name(s)
[18F]FPEB PET imaging
Intervention Description
PET exam
Intervention Type
Other
Intervention Name(s)
Biological samples
Intervention Description
blood sample and urine sample
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
MRI exam
Primary Outcome Measure Information:
Title
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
Time Frame
An average of 3 years
Secondary Outcome Measure Information:
Title
distribution volume of [18F]FPEB
Time Frame
An average of 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share data.

Learn more about this trial

Glutaminergic Transmission in Autism : Molecular Imaging Exploration

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