SV2 PET Imaging With [11C]APP311

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03995121

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia and Other Psychotic Disorders Cannabis Use Disorder Healthy	Radiation: [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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	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.	Radiation: [11C]APP311 It has been shown that [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.	Radiation: [11C]APP311 It has been shown that [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.	Radiation: [11C]APP311 It has been shown that [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.

Arm

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.

Radiation: [11C]APP311

It has been shown that [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.

Radiation: [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.

Radiation: [11C]APP311

Outcome Measures

Primary Outcome Measures

Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311 [One 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 Outcome Measures

Correlation of Synaptic density with cognition and EEG [One test day (one time point).]
To correlate SV2A density with concurrent measures of information processing such as cognitive performance on a neuropsychiatric battery and electroencephalograghic (EEG) measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Conneticut Mental Health Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patrick D. Skosnik, Associate Professor, Yale University

ClinicalTrials.gov Identifier:

NCT03995121

Other Study ID Numbers:

2000021592

First Posted:

Jun 21, 2019

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022