NCT05462340

PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia

PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia: Cognitive Relationships

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to use specialized brain imaging techniques, Positron Emission Tomography (PET) scan and Magnetic Resonance Imaging (MRI), to learn more about the brain chemistry, e.g., how neurotransmitters and receptors in the brain function in people with schizophrenia compared to healthy controls.

Detailed description

Abnormalities in brain chemistry can be responsible for the hallucinations and delusions; thus, by treating these abnormalities, physicians can reduce symptoms of schizophrenia. In this study, investigators aim to examine the characteristics of two investigational radiotracers, \[18F\]AZAN and \[18F\]ASEM, in the brains of people with schizophrenia and healthy controls. Radiotracers are drugs in which one or more atoms are "labeled" with a small amount of radioactivity that allows investigators to see how the drug works in humans using PET and MRI brain imaging techniques.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	[18F]ASEM	\[18F\]ASEM demonstrated excellent imaging properties, as was recently confirmed by others. \[18F\]ASEM is the 1st validated α7 human PET radiotracer to examine α7-nAChR characteristics in the living brain of SCZ patients. Previous α7 studies in the SCZ literature were done using brains harvested post-mortem, and under variable storage conditions. The proposed studies will also determine α4β2-nAChR \[18F\]AZAN binding characteristics in the same subjects who complete α7-nAChR PET studies with \[18F\]ASEM, which will be highly significant for understanding these receptors in SCZ.
DRUG	[18F]AZAN	The most widely used PET radioligand for human imaging of α4β2-nAChR is 2-\[18F\]FA. Because 2-\[18F\]FA exhibits very slow brain kinetics, the investigators developed \[18F\]AZAN, a highly α4β2 specific tracer with optimal brain kinetics. Therefore, the proposed studies will utilize \[18F\]AZAN to determine α4β2-nAChR \[18F\]AZAN binding characteristics in the same subjects who complete α7-nAChR PET studies with \[18F\]ASEM, which will be highly significant for understanding these receptors in SCZ.

Timeline

• Start date: 2022-08-18
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2022-07-18
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study