A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease
Status:
Recruiting
Trial end date:
2023-06-07
Target enrollment:
Participant gender:
Summary
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