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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038840
Recruitment Status : Enrolling by invitation
First Posted : July 31, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Weston Havens Foundation
Information provided by (Responsible Party):
Jong Yoon, Stanford University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: [11C]UCB-J radiotracer Device: PET-MR Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Imaging Synapses With [11C] UCB-J in the Human Brain
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038840


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Davidzon, Guido, M.D.
Weston Havens Foundation
Investigators
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Principal Investigator: Jong H Yoon, MD Stanford University
Publications:

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Responsible Party: Jong Yoon, Associate Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT04038840    
Other Study ID Numbers: 46106
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders