Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder

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