NCT04038840 Imaging Synapses With [11C] UCB-J in the Human Brain
| NCT ID | NCT04038840 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Davidzon, Guido, M.D. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-08-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2019-08-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer \[11C\]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ability to directly examine the synaptic pathology underlying neuropsychiatric disease. The neural synaptic pruning hypothesis posits that a key pathogenic process of schizophrenia is the over-exuberant elimination of neural synapses during development. The confirmation of reduced synaptic density in schizophrenia as evidenced by \[11C\]UCB-J has the potential to lead to a number of ground-breaking clinical innovations, such as laboratory-based diagnostics and prognostics, and novel, disease-modifying treatments.
Eligibility 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
Contact & Investigator
Jong H Yoon, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04038840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04038840 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04038840 currently recruiting?
Yes, NCT04038840 is actively recruiting participants. Contact the research team at brain-research@stanford.edu for enrollment information.
Where is the NCT04038840 trial being conducted?
This trial is being conducted at Palo Alto, United States, Stanford, United States.
Who is sponsoring the NCT04038840 clinical trial?
NCT04038840 is sponsored by Davidzon, Guido, M.D.. The principal investigator is Jong H Yoon, MD at Stanford University. The trial plans to enroll 60 participants.
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