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Memantine in Moderate to Severe Alzheimer’s Disease

Memantine in Moderate to Severe Alzheimer’s 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. Study Design. No. of patients N = 252 (outpatients) Diagnosis Probable Alzheimer’s disease

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Memantine in Moderate to Severe Alzheimer’s Disease

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  1. Memantine in Moderate to Severe Alzheimer’s 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 Probable Alzheimer’s 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. 3.6 3.8 4.0 4.2 4.4 4.6 4.8 5.0 N = 126 both groups N = 107 * N = 97  Memantine (20 mg/day)  Placebo N = 105 N = 84 0 12 28 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. N=119 1 0 -1 -2 -3 -4 -5 -6 -7 N = 107 N = 126 both groups * N = 97 N = 117 N = 106  Memantine (20 mg/day)  Placebo N = 84 0 4 12 28 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. 4 2 0 -2 -4 -6 -8 -10 -12 N = 119 N = 107 N = 126 both groups * N = 117 N = 97  Memantine (20 mg/day)  Placebo N = 106 N = 83 0 4 12 28 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 Alzheimer‘s disease • Good safety and tolerability of memantine Reisberg et al., N Engl J Med 2003

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