SV2 PET Imaging With [11C]APP311

Study Overview
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Brief Summary
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The aim of this study is to evaluate a new SV2A tracer, [11C]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.

Detailed Description
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The overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new PET tracer. Secondary outcomes will include electroencephalography (EEG). A battery of EEG paradigms assessing sensory, perceptual, and cognitive functions will also be administered. The primary dependent measures will be traditional event related potentials (ERPs; e.g. latency and amplitude) as well as time X frequency analysis (inter-trial coherence and spectral power).

Official Title
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Synaptic Density in Psychiatric Disorders Using SV2A Receptor PET Imaging With [11C]APP311

Conditions
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Healthy, Schizophrenia and Other Psychotic Disorders, Cannabis Use Disorder

Intervention / Treatment
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* Radiation: [11C]APP311


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give voluntary written informed consent Male and Female subjects, age 18 to 65 years, inclusive Exclusion Criteria: MRI metal exclusions and claustrophobia. Education completed is less than 12 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Schizophrenia and other psychotic disorders<br>For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. | Radiation: [11C]APP311<br>* It has been shown that [11C]APP311 (aka [11C]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density.<br>|
| Cannabis Use Disorder<br>For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. | Radiation: [11C]APP311<br>* It has been shown that [11C]APP311 (aka [11C]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density.<br>|
| Healthy Control<br>For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. | Radiation: [11C]APP311<br>* It has been shown that [11C]APP311 (aka [11C]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311 | To compare synaptic vesicle protein 2A (SV2A) density in two groups of subjects with psychiatric disorders (namely 'schizophrenia and other psychotic disorders', and 'cannabis use disorder') to that in healthy controls using the PET radiotracer 11C-APP311 | One test day (one time point). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Synaptic density with cognition and EEG | To correlate SV2A density with concurrent measures of information processing such as cognitive performance on a neuropsychiatric battery and electroencephalograghic (EEG) measures | One test day (one time point). |