Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Slee… (NCT05904717) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder
Australia, United Kingdom40 participantsStarted 2023-11-08
Plain-language summary
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.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. Ability to provide written informed consent in accordance with GCP, International Council for Harmonisation (ICH) and local regulations.
✓. Male or female aged 50 to 80 (inclusive) as of the date of Baseline visit.
✓. Clinical diagnosis of iRBD according to International Classification of Sleep Disorders (ICSD)-3 criteria.
✓. Objective evidence of 1 or more features of parkinsonism, impaired olfaction and/or impaired color vision discrimination, which have been associated with an increased risk for transitioning to a synucleinopathy in the opinion of the Investigator.
✓. Screening PET scan demonstrates robust PK11195 signal in striato-cortical region of interest in the opinion of the Investigator.
✓. Liver Function Tests (LFTs): alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 2.8 g/dL.
✓. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (human chorionic gonadotropin \[hCG\]) at Screening. WOCBP who engage in heterosexual intercourse and men whose sexual partners are WOCBP must agree to use highly effective, double barrier contraception during the study and for a period of 90 days following final dosing. Double barrier contraception is defined as a condom and 1 other form of the following:
✓. Contraceptive pill
Exclusion criteria
✕. Meets diagnostic criteria for a degenerative neurologic disorder such as Parkinson's disease, Multiple System Atrophy, Dementia with Lewy Bodies, etc.
What they're measuring
1
To assess the reduction of microglial activation across striato-cortical regions
Timeframe: Up to Week 12
2
To assess the safety and tolerability of PXS-4728A as determined by adverse events (AEs)