A 24-week open-label extension study of memantine in moderate to severe Alzheimer disease
Reisberg B, Doody R, Stoffler A, Schmitt F, Ferris S, Mobius HJ Arch Neurol 2006; 63(1):49-54
BACKGROUND: This study is an extension of a 28-week, randomized, double-blind, placebo-controlled study of memantine in 252 patients with moderate to severe Alzheimer disease.
OBJECTIVE: To evaluate long-term memantine treatment in moderate to severe Alzheimer disease.
DESIGN, SETTING, AND PATIENTS: Open-label, 24-week extension trial. Raters remained blind to the patients' initial study treatment. Patients (n = 175) were enrolled from the previous double-blind study in an outpatient setting.
INTERVENTION: Twenty mg of memantine was given daily.
MAIN OUTCOME MEASURES: Efficacy assessments from the double-blind study were continued and safety parameters were monitored. RESULTS: Patients who switched to memantine treatment from their previous placebo therapy experienced a significant benefit in all main efficacy assessments (functional, global, and cognitive) relative to their mean rate of decline with placebo treatment during the double-blind period (P<.05). the="" completion="" rate="" for="" the="" extension="" phase="" of="" the="" study="" was="" high="" (78%)="" and="" the="" favorable="" adverse="" event="" profile="" for="" memantine="" therapy="" was="" similar="" to="" that="" seen="" in="" the="" double-blind="">
CONCLUSION: These results extend previous findings that demonstrated the efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease