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Memantine in Clinical Practice – Results of an Observational Study

Memantine in Clinical Practice – Results of an Observational Study. Calabrese P., Essner U. and Förstl H. Dementia and Geriatric Cognitive Disorders 2007; 24: 111-117. Study Design. No. of patients N = 1845

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Memantine in Clinical Practice – Results of an Observational Study

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  1. Memantine in Clinical Practice – Results of an Observational Study Calabrese P., Essner U. and Förstl H. Dementia and Geriatric Cognitive Disorders 2007; 24: 111-117

  2. Study Design No. of patients N = 1845 Diagnosis moderate to severe Alzheimer’s disease (based on ICD-10 criteria) Design Open-label, multicenter, post-marketing observational study Dose; duration 20 mg memantine/day; 6 months Outcome measures MMSE, NOSGER, EMD (“Explorationsmodul Demenz”) Overall clinical impression, cognition and activities of daily living (rated by physician) Safety and tolerability Calabrese et al., Dement Geriatr Cogn Disord 2007

  3. Baseline Characteristics Memantine Gender, female 58.2% Mean age,years (±SD)76.3 (± 8.7) Mean height,cm (±SD)167.1 (± 8.1) Mean weight, kg (±SD) 70.3 (± 11.5) MMSE score, mean (±SD)15.4 (± 5.7) Mean duration of AD,years (±SD)2.4 (± 1.9) Calabrese et al., Dement Geriatr Cogn Disord 2007

  4. Concomitant Diseases and Comedication Concomitant disease % patients Hypertension 44.5 Heart failure 24.0 Arteriosclerosis 19.7 Other cardiac diseases 2.6 Diabetes mellitus 17.2 Other 22.4 Comedication % patients Antihypertensive drugs 41.2 Antidiabetic drugs 13.4 Antidepressants 11.3 Neuroleptic drugs 9.3 Calabrese et al., Dement Geriatr Cogn Disord 2007

  5. Significant Improvement of Mean MMSE Scores after 3 and 6 Months OC analysis Baseline * 3 months * 6 months 5 10 15 20 25 Mean MMSE score * p < 0.0001 vs baseline Calabrese et al., Dement Geriatr Cogn Disord 2007

  6. Responder Analysis – Stabilization and Improvement under Memantine MMSE Score 6 points improvement 3-6 points improvement 1-2 points improvement Stabilization 68.2% of patients showed improvement 30 35 40 5 10 15 20 25 Proportion of patients (%) Calabrese et al., Dement Geriatr Cogn Disord 2007

  7. Significant Improvement in All Items of the NOSGER Score Mean change from baseline Memory Instrumental Activities of Daily Living Activities of Daily Living Mood Social Behavior Disruptive Behavior 3 months 6 months p < 0.0001 vs baseline for all items at 3 and 6 months -0.8 -0.2 -0.4 -0.6 -1.0 -1.2 -1.4 -1.6 0 NOSGER score difference Improvement Calabrese et al., Dement Geriatr Cogn Disord 2007

  8. Significant Improvement in EMD Total Score (Patient and Caregiver) Area A = cognition Area B = everyday behavior and affectivity Area C = disease-related self-awareness Area A+B Area A Area B Area C Patient * Area A+B Area A Area B Area C Baseline 6 months Caregiver 6 9 8 7 5 4 3 1 2 0 10 Mean EMD score Improvement * p < 0.0001 Calabrese et al., Dement Geriatr Cogn Disord 2007

  9. Overall Clinical Impression: Improvement or Stabilization after 6 Months under Memantine 78.8% of patients improved or stabilized Improvement Stabilization Deterioration No answer 50 10 20 30 40 Proportion of patients (%) Calabrese et al., Dement Geriatr Cogn Disord 2007

  10. Positive Effect of Memantine Treatment on Cognition and Function after 6 months of treatment Good/Very Good Moderate Poor Cognition Daily functioning 40 10 20 30 50 0 Proportion of patients (%) Calabrese et al., Dement Geriatr Cogn Disord 2007

  11. Safety and Tolerability Adverse event % patients Restlessness 0.5 Dizziness 0.4 Pneumonia 0.4 Deterioration of AD 0.4 Confusion 0.3 Cerebrovascular events 0.3 Heart failure 0.3 Aggression 0.3 Dehydration 0.3 Nausea 0.2 Paranoia 0.2 Agitation 0.2 Urinary tract infection 0.2 Calabrese et al., Dement Geriatr Cogn Disord 2007

  12. Summary • This study demonstrated memantine’s efficacy and safety in a real world patient population over six months of treatment • Significant improvement on the MMSE Score (2.5 points on average) • Improvement in memory, activities of daily living and behavior as assessed by the NOSGER • These effects were also visible to the treating physician, proven by the global assessments • This observational study confirms the efficacy of memantine already seen in placebo-controlled clinical studies • Memantine showed an excellent safety and tolerability profile • 74.4% patients had concomitant diseases with 65.4% receiving corresponding comedication • None of the individual AEs occurred at a higher frequency than 0.5% • These findings demonstrate the relevance of memantine’s efficacy in every day practice Calabrese et al., Dement Geriatr Cogn Disord 2007

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