- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995121
SV2 PET Imaging With [11C]APP311 (SV2)
February 12, 2024 updated by: Yale University
Synaptic Density in Psychiatric Disorders Using SV2A Receptor PET Imaging With [11C]APP311
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Luddy, BS
- Phone Number: 4549 203-932-5711
- Email: christina.luddy@yale.edu
Study Contact Backup
- Name: Rachel Hird, BS
- Phone Number: 203-974-7775
- Email: rachel.hird@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Recruiting
- Conneticut Mental Health Center
-
Contact:
- Patrick Skosnik
- Phone Number: 2159 203-932-5711
- Email: patrick.skosnik@yale.edu
-
Contact:
- Rajiv Radhakrishnan
- Phone Number: 4443 2039325711
- Email: rajiv.radhakrishnan@yale.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Recruiting Subjects with Schizophrenia and other Psychotic disorders Cannabis Use Disorder Healthy controls
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311
Time Frame: 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
|
One test day (one time point).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of Synaptic density with cognition and EEG
Time Frame: 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 electroencephalographic (EEG) measures
|
One test day (one time point).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
June 19, 2019
First Submitted That Met QC Criteria
June 19, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000021592
- 1R01DA054314-01 (U.S. NIH Grant/Contract)
- 1R21DA054491-01 (U.S. NIH Grant/Contract)
- 36C24820C0079 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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