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NCT02719951 Clinical Trial

Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Healthy Volunteers Clinical Trial

— TANGAU  

Official title:
Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02719951
Other study ID # PRIA 14 FBB / TANGAU
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2016
Est. completion date May 2019

Study information
Verified date May 2019
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date May 2019
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• [18F]FPEB PET imaging
PET exam
Other:
• Biological samples
blood sample and urine sample
• MRI
MRI exam

Locations
Country Name City State
France CHU Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary cerebral glutaminergic activity assessed by binding potential of [18F]FPEB An average of 3 years
Secondary distribution volume of [18F]FPEB An average of 3 years
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