A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease

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

Timeline

Start

2022-06-07

Primary completion

2024-06-04

Completion

2024-06-04

Outcome

Outcome not reported

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.”

Publications

• Results Nuytten M, Voets M, Debroux E, Princen K, Pringels L, Fivaz M, Byl E, Ramael S, De Witte K, Boada M, Morato X, Tartari JP, Lafuente A, Macias EF, Matias-Guiu JA, Vijverberg E, Teunissen CE, Anderer P, Staggs V, Hayman V, Corbett A, Ballard C, Harrison JE, Windisch M, Westman AB, Zetterberg H, Dickson S, Mallinckrodt C, Hendrix S, Cummings J, Griffioen G. Randomized phase 2a trial assessing a novel septin molecular glue in Alzheimer's disease. Alzheimers Dement. 2025 Sep;21(9):e70537. doi: 10.1002/alz.70537.

Drugs

Indications