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RecruitingAccepts healthy volunteersPhase 1

Imaging Synapses With [11C] UCB-J in the Human Brain

Davidzon, Guido, M.D. · with Weston Havens Foundation · NCT04038840

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
60
US sites recruiting
2
Study start
August 1, 2019
Record last updated
December 16, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: [11C]UCB-J radiotracer; PET-MR

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Study Coordinator · 650-849-0552 · brain-research@stanford.edu
All mental health studies in California →
Imaging Synapses With [11C] UCB-J in the Human Brain (NCT04038840) | Bored Studies