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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03995121
Other study ID # 2000021592
Secondary ID 1R21DA054491-011
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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).
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