Recruiting
Phase 1

[11C] UCB-J

Sponsor:

Davidzon, Guido, M.D.

Code:

NCT04038840

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

[11C]UCB-J radiotracer

PET-MR

Study Details

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.

Conditions

Schizophrenia

Study ID

NCT04038840

Start date

Aug 1, 2019

Status verified date

Dec, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Healthy Control (HC) Participants

Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer

experimental: Schizophrenia (SZ) Participants

Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer

Interventions

[11C]UCB-J radiotracer

I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein

PET-MR

Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes

Primary outcome measure

  • Cross-sectional differences in synaptic density between HC and SZ participants [ Time Frame: 120 minutes (scan duration) ]

Central Contacts and Locations

Central contacts

Study Coordinator

650-849-0552brain-research@stanford.edu

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Stanford University

Recruiting

Stanford, California, United States, 94305

More Information

Sponsor

Davidzon, Guido, M.D.

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Davidzon, Guido, M.D. on 2024-12-16.