SV2 PET Imaging With [11C]APP311 (SV2)

Synaptic Density in Psychiatric Disorders Using SV2A Receptor 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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Cannabis Use Disorder; Schizophrenia and Other Psychotic Disorders
• Intervention / Treatment: Drug: [11C]APP311

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).

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Angerlyk Frytz, MD; Phone Number: 203-974-7822; Email: angerlyk.frytz@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Conneticut Mental Health Center
      • Contact: Deepak C D'Souza, MD; Phone Number: 2594 203-932-5711; Email: deepak.dsouza@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Recruiting Subjects with Schizophrenia and other Psychotic disorders Cannabis Use Disorder Healthy controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Schizophrenia and other psychotic disorders; 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.	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.
Cannabis Use Disorder; 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.	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.
Healthy Control; 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.	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.

What is the study measuring?

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 electroencephalographic (EEG) measures	One test day (one time point).

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 2000021592; 1R01DA054314-01 (U.S. NIH Grant/Contract); 36C24820C0079 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No