Trial | NCT04038840  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    60
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 Started
Aug 01
2019
Primary Completion
Dec 31
2025
Anticipated
Study Completion
Dec 31
2025
Anticipated
Last Update
Nov 18
2023

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

Healthy Control (HC) Participants Experimental

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

Schizophrenia (SZ) Participants Experimental

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

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
No Results Posted