Glutaminergic Transmission in Autism : Molecular Imaging Exploration (TANGAU)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Fragile-X Syndrome (FXS); Autism

Treatments: Drug: [18F]FPEB PET imaging; Other: MRI; Other: Biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02719951

PRIA 14 FBB / TANGAU

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

autistic patients

Experimental group

Description:

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

Treatment:

Other: Biological samples

Other: MRI

Drug: [18F]FPEB PET imaging

FXS patients

Experimental group

Description:

\[18F\]FPEB PET imaging MRI Biological samples

Treatment:

Other: Biological samples

Other: MRI

Drug: [18F]FPEB PET imaging

Healthy subjects

Experimental group

Description:

\[18F\]FPEB PET imaging MRI Biological samples

Treatment:

Other: Biological samples

Other: MRI

Drug: [18F]FPEB PET imaging