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Recruiting NCT03995121

SV2 PET Imaging With [11C]APP311

Observational Schizophrenia and Other Psychotic Disorders Cannabis Use Disorder Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [11C]APP311.
Who it may be relevant to
Registry conditions: Schizophrenia and Other Psychotic Disorders, Cannabis Use Disorder, Healthy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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).

Interventions

  • Drug [11C]APP311
    It has been shown that radiotracer \[11C\]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.

Primary outcome measures

  • Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311 [Time frame: One test day (one time point).]
Secondary outcome measures (1)
  • Correlation of Synaptic density with cognition and EEG [Time frame: One test day (one time point).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Conneticut Mental Health Center — New Haven

Identifiers

NCT: NCT03995121 · 2000021592 · 1R01DA054314-01 · 36C24820C0079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗