Stopped: Due to the event of repeated elevated transaminase levels in one subject - elevated ALT/AST up to 6x ULN in the absence of any other potential underlying cause - we have decided to terminate the study.
The purpose of this study is to measure effects on CSF biomarkers, EEG and safety with REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer disease. * The study duration will be up to 2 months for each treated subject * Each subject will start with a 14-day placebo run-in period, followed by a 28-day treatment period and 7-day follow-up period * Visit frequency: every week * Number of Subjects: at least 30 subjects with an upper limit of 60 subjects. * Study Arms and Duration: All subjects will be randomized (1:1:1 allocation) to one ofthree different starting levels after the 14-day run-in period: * REM0046127 high dose: 1400mg (700mg bid) oral suspension per day for 28 days * REM0046127 low dose: 350mg (175mg bid) oral suspension per day for 28 days * Placebo: placebo oral suspension bid for 28 days
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adverse Events
Timeframe: From first dosing to 7 days after last dose as follow-up. 14 days Run-in + 28 days treament + 7 days Follow-up