One-week dose titration of extended release galantamine in patients with Alzheimer’s disease

Background: Our purpose was to assess the safety and tolerability of extended-release galantamine (GAL-ER), using a 1-week dose titration in Alzheimer's patients. Methods: An open-label, 12-week, multicenter study was performed (n = 82). Results were compared with findings from a placebo-controlled trial using a 4-week titration of GAL-ER and immediate-release galantamine. The primary analysis compared incidences of adverse events (AEs). Results: Although not statistically significant, more patients in the I-week titration study experienced an AE. More patients with a 1-week titration had at least one prespecified gastrointestinal (GI) AE. These findings correlated with a higher baseline incidence of GI disturbances. Four patients experienced serious AEs; no deaths occurred. Mean Mini-Mental State Examination scores improved by 1.8 and 1.9 points at weeks 4 and 12, respectively. Conclusions: A1-week titration of GAL-ER was generally safe and well tolerated, with a potential risk of more GI side effects. A1-week titration may permit dosing flexibility and promote increased adherence to medication regimens. (C) 2009 The Alzheimer's Association. All rights reserved.