Imaging synapses in the human brain using a PET tracer
Imaging Synapses With [11C] UCB-J in the Human Brain
PHASE1 · Stanford University · NCT04038840
This study is testing a new brain imaging method to see if people with schizophrenia have fewer connections between brain cells, which could help improve how we diagnose and treat the condition.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Trial ID | NCT04038840 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize the radioactive PET tracer [11C]UCB-J to investigate the neural synaptic pruning hypothesis in schizophrenia. By quantifying synaptic density in the living human brain, the study seeks to confirm reduced synaptic density as a key pathological feature of schizophrenia. This innovative imaging method could lead to groundbreaking advancements in diagnostics and treatments for neuropsychiatric diseases. Participants will undergo PET-MR scans to assess synaptic pathology associated with their condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with a clinical diagnosis of schizophrenia or related disorders who are stable on their medication.
Not a fit: Patients with active substance use, significant neurological illnesses, or those unable to undergo MR scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostics and novel treatments for schizophrenia.
How similar studies have performed: While the approach of using [11C]UCB-J for imaging synapses is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 - 65 years in age * For SZ participants: * On a stable medication regimen for at least two weeks prior to testing * A clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder * Able to complete a PET-MR scan without the use of sedation Exclusion Criteria: * Active substance use within three months of testing * IQ \< 70 * Major medical neurological illness or significant head trauma * Pregnancy or breastfeeding * Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ * Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate * History of or current claustrophobia * Inability to comply with basic study requirements such as following directions and punctuality * For HC participants: * Presence of a first degree relative with a psychotic disorder * Lifetime diagnosis of major psychiatric illness * For SZ participants: * Unstable psychiatric symptoms at the time of testing, e.g. acute suicidality, prominent psychosis, or behavioral dyscontrol
Where this trial is running
Palo Alto, California and 1 other locations
- VA Palo Alto Health Care System — Palo Alto, California, United States (RECRUITING)
- Stanford University — Stanford, California, United States (RECRUITING)
Study contacts
- Principal investigator: Jong H Yoon, MD — Stanford University
- Study coordinator: Study Coordinator
- Email: brain-research@stanford.edu
- Phone: 650-849-0552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia