Recruiting

SV2 PET Imaging

Sponsor:

Yale University

Code:

NCT03995121

Conditions

Schizophrenia and Other Psychotic Disorders

Cannabis Use Disorder

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

[11C]APP311

Study Details

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

Study ID

NCT03995121

Start date

Dec 1, 2017

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

[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 measure

  • Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311 [ Time Frame: One test day (one time point). ]

Central Contacts and Locations

Central contacts

Angerlyk Frytz, MD

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

Locations

Conneticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Deepak C D'Souza, MD

203-932-5711deepak.dsouza@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Yale University on 2026-01-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.