SV2 PET Imaging With [11C]APP311

NCT ID: NCT03995121

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2026-12-31

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.

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).

Conditions

Schizophrenia and Other Psychotic Disorders; Cannabis Use Disorder; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

[11C]APP311

Intervention Type: 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

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.

[11C]APP311

Intervention Type: 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.

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.

[11C]APP311

Intervention Type: 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.

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Deepak C. D'Souza

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Conneticut Mental Health Center

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angerlyk Frytz, MD

Role: CONTACT

angerlyk.frytz@yale.edu

203-974-7822

Facility Contacts

Deepak C D'Souza, MD

Role: primary

deepak.dsouza@yale.edu

203-932-5711 ext. 2594

Other Identifiers

1R01DA054314-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

36C24820C0079

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000021592

Identifier Type: -

Identifier Source: org_study_id