Phase 2Active, not recruitingAge-related condition
Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder
A Phase 2a, Multi Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of 12 Weeks Treatment With Oral PXS-4728A on Microglia Activation, as Measured by Positron Emission Tomography, in Participants With Isolated Rapid Eye Movement Sleep Behavior Disorder
- Sponsor
- Syntara (Industry)
- Enrolment
- 40 enrolled
- Conditions
- REM Sleep Behavior Disorder
- Interventions
- PXS-4728 (A); Matching Placebo (B)
- Ages
- adults, older adults
- Registry
- NCT05904717
Full record on ClinicalTrials.gov
From the registry
This study is to investigate the safety and efficacy of PXS-4728A as an intervention therapy in participants with iRBD. This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level.
Primary outcomes
- To assess the reduction of microglial activation across striato-cortical regions
- To assess the safety and tolerability of PXS-4728A as determined by adverse events (AEs)
History
Study completion
Last registry update
Primary completion
Started
Registered