A 24-week open-label extension study of memantine in moderate to severe Alzheimer disease.
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.


METHODS
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.


METHODS
Twenty mg of memantine was given daily.


METHODS
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 study.


CONCLUSIONS
These results extend previous findings that demonstrated the efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease.
Reisberg
Barry
B
Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA. barry.reisberg@med.nyu.edu
Doody
Rachelle
R
Stöffler
Albrecht
A
Schmitt
Frederick
F
Ferris
Steven
S
Möbius
Hans Jörg
HJ
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000503:physiopathology; D018450:Disease Progression; D004311:Double-Blind Method; D018691:Excitatory Amino Acid Antagonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008559:Memantine / Q000627:therapeutic use*; D008609:Mental Status Schedule / Q000706:statistics & numerical data; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome
D018691:Excitatory Amino Acid Antagonists; D008559:Memantine