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SV2 PET Imaging With [11C]APP311

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03995121
Acronym
SV2
Enrollment
250
Registered
2019-06-21
Start date
2017-12-01
Completion date
2026-12-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Use Disorder, Healthy, Schizophrenia and Other Psychotic Disorders

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).

Interventions

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.

Sponsors

Yale University
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311One 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

MeasureTime frameDescription
Correlation of Synaptic density with cognition and EEGOne 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

Countries

United States

Contacts

CONTACTAngerlyk Frytz, MD
angerlyk.frytz@yale.edu203-974-7822

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026