drugset / Trial / NCT07423546

A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

NCT07423546

RandomizedParallel-groupQuadruple-blindOther

Summary

This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \[18F\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission. The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by \[18F\]DOPA Kicer (\[18F\]DOPA relative uptake rate)).

Timeline

Start
2026-07-01
Primary completion
2027-04-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Trospium Small molecule 20 mg
Subject Trospium Small molecule 30 mg
Subject Xanomeline Small molecule 50 mg
Subject Xanomeline Small molecule 100 mg
Subject Xanomeline Small molecule 125 mg