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NCT Number: NCT03995121

SV2 PET Imaging With [11C]APP311

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.

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Key information

Conditions

Schizophrenia and Other Psychotic Disorders Cannabis Use Disorder Healthy Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Conneticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Deepak C D'Souza, MD

CONTACT

[email protected]

203-932-5711 ext. 2594

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]APP311

Drug

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 outcomes

  1. Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311

    Time frame: One test day (one time point).

    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

Secondary outcomes

  1. Correlation of Synaptic density with cognition and EEG

    Time frame: One test day (one time point).

    To correlate SV2A density with concurrent measures of information processing such as cognitive performance on a neuropsychiatric battery and electroencephalographic (EEG) measures

Study contacts

Contact information is provided by the study sponsor or research team.

Angerlyk Frytz, MD

CONTACT

[email protected]

203-974-7822

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: SV2

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2019
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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