Safety and tolerability of once-daily versus twice-daily memantine: a randomised, double-blind study in moderate to severe Alzheimer's disease

摘要: Objective To assess the safety and tolerability of three different dosing schedules memantine in patients with moderate to severe Alzheimer's disease (AD). Method This 12-week, randomised, double-blind study, investigated memantine: OD1 (20 mg once daily a 1-step up-titration); OD3 3-step BID3 (10 twice up-titration as currently recommended labelling). The study comprised 78 AD (DSM-IV-TR criteria; MMSE score ≤18), 70% whom were on stable acetylcholinesterase inhibitor (AChEI) initiated ≥3 months prior start. Safety assessed by number withdrawals, adverse events (AEs) monitoring vital signs. Results The patient withdrawals was low: 3 27 OD1, 1 25 2 26 BID3. One or more AEs reported 9 7 12 Most mild moderate, typical for population studied; no clinically important differences signs observed between schedules. There between-group efficacy, clinical global severity change. These results are consistent good profile larger studies. Conclusions Although relatively small size, indicates that once-daily twice-daily similar terms tolerability. Copyright © 2007 John Wiley & Sons, Ltd.