AutismPhase 1TANGAUNCT02719951
Glutaminergic Transmission in Autism : Molecular Imaging Exploration
A Phase 1 study testing [18F]FPEB PET imaging, Biological samples and MRI in people with Autism and Fragile-X Syndrome (FXS), run by University Hospital, Tours at 1 site in France.
Trial summary
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism, Fragile-X Syndrome (FXS), Healthy Volunteers
- What is being tested?
- [18F]FPEB PET imaging, Biological samples and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers
- Conditions
- Autism, Fragile-X Syndrome (FXS), Healthy Volunteers
- Being tested
- [18F]FPEB PET imaging, Biological samples, MRI
- Keywords
- autism, fragile X syndrome (FXS), PET (Positron Emission Tomography), glutamate
- Medical subject headings
- Autistic Disorder, Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FPEB PET imagingDrug
PET exam
Biological samplesOther
blood sample and urine sample
MRIOther
MRI exam
| Study group | Role | What they receive |
|---|---|---|
| autistic patients | Experimental | [18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples Receives: Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI |
| FXS patients | Experimental | [18F]FPEB PET imaging MRI Biological samples Receives: Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI |
| Healthy subjects | Experimental | [18F]FPEB PET imaging MRI Biological samples Receives: Drug: [18F]FPEB PET imaging; Other: Biological samples; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
Measured: An average of 3 years
Secondary outcomes (1)
distribution volume of [18F]FPEB
Measured: An average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion15 Nov 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719951
- Sponsor's protocol ID
- PRIA 14 FBB / TANGAU
- Acronym
- TANGAU
- Status last verified
- Dec 2025
- First submitted
- 9 Mar 2016
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to share data.
Publications
Dupont AC, Serriere S, Barantin L, Vercouillie J, Tauber C, Gissot V, Bodard S, Chicheri G, Chalon S, Bonnet-Brilhault PF, Santiago-Ribeiro PM, Arlicot N. Study of influence of the glutamatergic concentration of [18F]FPEB binding to metabotropic glutamate receptor subtype 5 with N-acetylcysteine challenge in rats and SRM/PET study in human healthy volunteers. Transl Psychiatry. 2021 Jan 20;11(1):66. doi: 10.1038/s41398-020-01152-2.
PubMed 33473111
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutaminergic Transmission in Autism : Molecular Imaging Exploration
- ClinicalTrials.gov ID
- NCT02719951
- Acronym / sponsor ID
- TANGAU / PRIA 14 FBB / TANGAU
- Conditions
- Autism, Fragile-X Syndrome (FXS), Healthy Volunteers
- Keywords
- autism, fragile X syndrome (FXS), PET (Positron Emission Tomography), glutamate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| autistic patients | Experimental | Drug: [18F]FPEB PET imaging, Other: Biological samples, Other: MRI[18F]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples |
| FXS patients | Experimental | Drug: [18F]FPEB PET imaging, Other: Biological samples, Other: MRI[18F]FPEB PET imaging MRI Biological samples |
| Healthy subjects | Experimental | Drug: [18F]FPEB PET imaging, Other: Biological samples, Other: MRI[18F]FPEB PET imaging MRI Biological samples |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FPEB PET imagingPET exam | Drug | FXS patients, Healthy subjects, autistic patients |
| Biological samplesblood sample and urine sample | Other | FXS patients, Healthy subjects, autistic patients |
| MRIMRI exam | Other | FXS patients, Healthy subjects, autistic patients |
Primary outcome
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
Time frame: An average of 3 years
1 secondary outcome
distribution volume of [18F]FPEB
Time frame: An average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Results publication: PubMed 33473111Dupont AC, Serriere S, Barantin L, Vercouillie J, Tauber C, Gissot V, Bodard S, Chicheri G, Chalon S, Bonnet-Brilhault PF, Santiago-Ribeiro PM, Arlicot N. Study of influence of the glutamatergic concentration of [18F]FPEB binding to metabotropic glutamate receptor subtype 5 with N-acetylcysteine challenge in rats and SRM/PET study in human healthy volunteers. Transl Psychiatry. 2021 Jan 20;11(1):66. doi: 10.1038/s41398-020-01152-2.
- Individual participant dataSharing planned: No. There is no plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]FPEB PET imaging, Biological samples and MRI in people with Autism and Fragile-X Syndrome (FXS), run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral glutaminergic activity assessed by binding potential of [18F]FPEB (time frame: An average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.