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Orgogozo J.M., Rigaud A.S., Stöffler A., Möbius H.J., and Forette F. Stroke 2002, 33:1834-1839

Efficacy and Safety of Memantine in Patients With Mild to Moderate Vascular Dementia A Randomized, Placebo-controlled Trial (MMM 300). Orgogozo J.M., Rigaud A.S., Stöffler A., Möbius H.J., and Forette F. Stroke 2002, 33:1834-1839. Study Design. No. of patients N = 321

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Orgogozo J.M., Rigaud A.S., Stöffler A., Möbius H.J., and Forette F. Stroke 2002, 33:1834-1839

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  1. Efficacy and Safety of Memantine in Patients With Mild to Moderate Vascular Dementia A Randomized, Placebo-controlled Trial (MMM 300) Orgogozo J.M., Rigaud A.S., Stöffler A., Möbius H.J., and Forette F. Stroke 2002, 33:1834-1839

  2. Study Design No. of patients N = 321 Design Double-blind, randomized, placebo- controlled, multicenter study Diagnosis Probable VaD (acc. NINDS-AIREN, HIS  5) Age  60 (mean 76) Severity MMSE 12 - 20 (mean 16.9) Dose; duration 20 mg memantine/day; 28 weeks Primary efficacy Cognition: ADAS-cogparameters Global: CIBIC-Plus Secondary efficacy MMSE, GBS, NOSGER, CGI-Cparameters Orgogozo et al., Stroke 2002

  3. Disposition of Patients Patients screenedN = 403 Screen failuresN = 82 (20%) Patients randomizedN = 321 PlaceboN = 156 (49%) MemantineN = 165 (51%) CompletedN = 118(76%) WithdrewN = 38(24%) CompletedN = 116(70%) WithdrewN = 49(30%) Orgogozo et al., Stroke 2002

  4. 19 20 21 22 23 24 *  Memantine (20 mg/day)  Placebo 0 12 28 Significant Benefit of Memantine on Cognition (ADAS-cog) ITT, LOCF ADAS-cog total score ADAS-cog total score Worsening Week *p = 0.0016 versus placebo Orgogozo et al., Stroke 2002

  5. -2 -1 0 1 2 3 *  Memantine (20 mg/day)  Placebo 0 12 28 Significant Benefit of Memantine on Cognition (ADAS-cog) ITT, LOCF Mean change from baseline Improvement ADAS-cog score difference Worsening Week *p = 0.0016 versus placebo Orgogozo et al., Stroke 2002

  6. 19 18 17 16  Memantine (20 mg/day)  Placebo * 0 28 Significant Benefit of Memantine on Cognition (MMSE) TPP, N = 188 MMSE analysis MMSE total score Worsening Week *p = 0.003 versus placebo Orgogozo et al., Stroke 2002

  7. Good Safety and Tolerability of Memantine Adverse events in mild to moderate VaD (MMM300) Memantine Placebo Total no. of patients 165 (100%) 156 (100%) Total no. of patients with AEs 117 (70.9%) 104 (56.7%) Agitation 9 (5.5%) 11 (7.1%) Confusion 8 (4.8%) 8 (5.8%) Dizziness 8 (4.8%) 5 (3.2%) Bronchitis 6 (3.6%) 7 (4.5%) Urinary Tract Infection 5 (3.0%) 7 (4.5%) Cerebrovascular Disorder 6 (3.6%) 6 (3.8%) Depression 6 (3.6%) 5 (3.2%) Diarrhoea 5 (3.0%) 6 (3.8%) Hypertension 4 (2.4%) 7 (4.5%) Inflicted Injury 5 (3.0%) 6 (3.8%) Orgogozo et al., Stroke 2002

  8. Summary • Significant cognitive benefit for patients with mild to moderate vascular dementia treated with memantine compared to placebo (ADAS-cog and MMSE ) • Good safety and tolerability of memantine Orgogozo et al., Stroke 2002

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