SV2 PET Imaging With [11C]APP311

Yale University

Status: Enrolling

Conditions: Healthy; Cannabis Use Disorder; Schizophrenia and Other Psychotic Disorders

Treatments: Drug: [11C]APP311

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03995121

36C24820C0079 (Other Grant/Funding Number)

1R01DA054314-01 (U.S. NIH Grant/Contract)

2000021592

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

250 participants in 3 patient groups

Schizophrenia and other psychotic disorders

Description:

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.

Treatment:

Drug: [11C]APP311

Cannabis Use Disorder

Description:

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.

Treatment:

Drug: [11C]APP311

Healthy Control

Description:

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.

Treatment:

Drug: [11C]APP311