Memantine in Moderate to Severe Alzheimer

1
Memantine in Moderate to Severe Alzheimers
Disease

• Reisberg B., Doody R., Stöffler A., Schmitt F.,
  Ferris S. H., and Möbius H. J.
• New England Journal of Medicine 2003, 348
  1333-1341

2
Study Design
No. of patients N 252 (outpatients) Diagnosis P
robable Alzheimers disease Design Double-blind,
randomized, placebo- controlled, multicenter
study Age ? 50 years (mean 76) Severity MMSE 3
14 (mean 7.9) GDS 5 6 FAST ? 6a Dose
duration 20 mg memantine/day 28 weeks Primary
efficacy Global CIBIC-plusparameters
Function ADCS-ADLsev Secondary
efficacy Cognition SIB, Behavior NPI
parameters MMSE, FAST, GDS, Resource
Utilisation in Dementia (RUD)
Reisberg et al., N Engl J Med 2003
3
Significant Benefit of Memantine in Clinical
Global Impression (CIBIC-Plus)
OC analysis 4.0 no change
Improvement
CIBIC-Plus global score
Worsening
Week
p 0.025 versus placebo
Reisberg et al., N Engl J Med 2003
4
Significant Benefit of Memantine in Activities of
Daily Living
OC analysis Mean change from baseline
Improvement
ADCS-ADLsev score difference
Worsening
Week
p 0.003 versus placebo
Reisberg et al., N Engl J Med 2003
5
Significant Benefit on Cognition (Severe
Impairment Battery)
OC analysis Mean change from
baseline
Improvement
SIB score difference
Worsening
Week
p 0.002 versus placebo
Reisberg et al., N Engl J Med 2003
6
Summary

• Statistically significant benefit of memantine
  compared to placebo on three independent levels
• clinical global impression
• functional capacity in activities of daily living
• cognition
• in moderate to severe Alzheimers disease
• Good safety and tolerability of memantine

Reisberg et al., N Engl J Med 2003