drugset / Trial / NCT07423546
A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |