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

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDavidzon, Guido, M.D.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

18 - 65 years in age

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

Disqualifiers

Active substance use within three months of testing

IQ < 70

Major medical neurological illness or significant head trauma

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • [11C]UCB-J radiotracer

    Drug

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

  • PET-MR

    Device

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Healthy Control (HC) ParticipantsExperimental treatment 2 interventions
Group B: Schizophrenia (SZ) ParticipantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cross-sectional differences in synaptic density between HC and SZ participants

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.

Time frame
120 minutes (scan duration)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Davidzon, Guido, M.D.

Lead sponsor

Stanford University

Sponsor institution

Weston Havens Foundation

Collaborator