Study of Three Doses of Cobenfy Xanomeline and Trospium Using PETMRI to Measure Dopamine Changes in Adults with Schizophrenia

What this Trial Is About

Researchers are studying the effects of Cobenfy, a combination of xanomeline and trospium chloride, on dopamine transmission in people with schizophrenia or related disorders. This clinical trial aims to measure how well Cobenfy engages its target, specifically dopamine transmission and synthesis capacity in the brain, using a special PET scan with 18FDOPA before and after treatment. The study is randomized and conducted at a single site with 12 participants. Participants will be randomly assigned to one of three dose groups receiving different amounts of xanomeline and trospium chloride low, middle, or high dose taken twice daily for 5 weeks. During the study, PET scans with 18FDOPA will be performed at the beginning and end of the treatment period to assess changes in dopamine uptake in the brain. This setup allows researchers to compare the effects of different doses of Cobenfy on dopamine transmission. Throughout the study, participants will be monitored closely to assess dopamine transmission changes using the PET scans. Eligibility requires participants to be antipsychotic-free for a specified time before the baseline scan and meet clinical criteria related to schizophrenia or related disorders. The primary outcome measured is the relative uptake rate of 18FDOPA in the brain before and after the 5-week treatment. Safety, adherence, and other clinical assessments will be part of the study, which is expected to complete by the end of 2027.

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