SV2 PET Imaging With [11C]APP311

Recruiting

• Conditions: Healthy; Schizophrenia and Other Psychotic Disorders; Cannabis Use Disorder
• Interventions: Radiation: [11C]APP311

• Registration Number: NCT03995121
• Lead Sponsor: Yale University

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).

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Willing and able to give voluntary written informed consent
• Male and Female subjects, age 18 to 65 years, inclusive

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Exclusion Criteria

• MRI metal exclusions and claustrophobia.
• Education completed is less than 12 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Schizophrenia and other psychotic disorders	[11C]APP311	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.
Healthy Control	[11C]APP311	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.
Cannabis Use Disorder	[11C]APP311	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 electroencephalographic (EEG) measures

Trial Locations

Locations (1)

Conneticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States