SV2 PET Imaging With [11C]APP311

Healthy Clinical Trial

— SV2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03995121
• Other study ID #: 2000021592
• Secondary ID: 1R21DA054491-011
• Status: Recruiting
• Start date: December 1, 2017
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Rachel Hird, BS
• Phone: 203-974-7775
• Email: rachel.hird[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Healthy
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Other Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Conneticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311	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	Correlation of Synaptic density with cognition and EEG	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).