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

December 11, 2024 updated by: Jong Yoon, Davidzon, Guido, M.D.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto Health Care System
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Control (HC) Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the [11C]UCB-J radiotracer
Drug: [11C]UCB-J radiotracer
I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein
Device: PET-MR
Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes
Experimental: Schizophrenia (SZ) Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the [11C]UCB-J radiotracer
Drug: [11C]UCB-J radiotracer
I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein
Device: PET-MR
Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-sectional differences in synaptic density between HC and SZ participants
Time Frame: 120 minutes (scan duration)
Synaptic density will be quantified with the regional binding potential (BP_ND), a measure of [11C]UCB-J binding. BP_ND will be derived by using the simplified reference tissue model 2 (Wu & Carson, 2002) and the centrum semiovale as the reference region. This method has been recently utilized by other investigators in neuropsychiatric samples (Chen et al., 2018). Both exploratory voxel-wise BP_ND and region of interest (ROI) BP_ND will be compared across groups. ROIs include the striatum, dorsolateral prefrontal cortex, hippocampus, and superior temporal cortex.
120 minutes (scan duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Davidzon, Guido, M.D.

Collaborators

Weston Havens Foundation

Investigators

  • Principal Investigator: Jong H Yoon, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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