SV2 PET Imaging With [11C]APP311

NCT03995121 | Recruiting FDA Drug

• 3 other identifiers: 20000215921R01DA054314-0136C24820C0079
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia and Other Psychotic Disorders; Cannabis Use Disorder; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of Synaptic density with cognition and EEG

  One test day (one time point).

Study Arms (3)

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

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

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

Interventions

[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.

Cannabis Use Disorder; Healthy Control; Schizophrenia and other psychotic disorders

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Willing and able to give voluntary written informed consent
• Male and Female subjects, age 18 to 65 years, inclusive

You may not qualify if:

• Education completed is less than 12 years

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Conneticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

When specimens and information are stored, researchers are careful to try to protect your identity from discovery by others. Samples and information will receive a unique code. Other researchers will only receive coded samples and information, and will not be able to link the code to subjects. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Angerlyk Frytz, MD

CONTACT

203-974-7822; angerlyk.frytz@yale.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: December 1, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)