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Wilcock G., Möbius H.J. and Stöffler A. on behalf of the MMM500 group

A Double-blind, Placebo-controlled Multicentre Study of Memantine in Mild to Moderate Vascular Dementia (MMM500). Wilcock G., Möbius H.J. and Stöffler A. on behalf of the MMM500 group Int Clin Psychopharmacol 2002, 17(6):297 – 305. Study Design. No. of patients N = 579

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Wilcock G., Möbius H.J. and Stöffler A. on behalf of the MMM500 group

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  1. A Double-blind, Placebo-controlled Multicentre Study of Memantine in Mild to Moderate Vascular Dementia (MMM500) Wilcock G., Möbius H.J. and Stöffler A. on behalf of the MMM500 group Int Clin Psychopharmacol 2002, 17(6):297–305

  2. Study Design No. of patients N = 579 Design Double-blind, randomized, placebo-controlled, multicenter study Diagnosis Probable VaD (HIS score ≥ 4, DSM-III-R, NINDS-AIREN) Age ≥ 54 years (mean 77) Severity MMSE 10 – 22 (mean 17.6) Dose; duration 20 mg memantine/day; 28 weeks Primary efficacy Cognition: ADAS-cogparameters Global: CGI-C Secondary efficacy MMSE, GBS, NOSGER parameters Wilcock et al., Int Clin Psychopharmacol 2002

  3. Disposition of Patients Patients screenedN = 840 Screen failuresN = 261 (31%) Patients randomizedN = 579 PlaceboN = 284 (49%) MemantineN = 295 (51%) CompletedN = 226(80%) WithdrewN = 58(20%) CompletedN = 238(81%) WithdrewN = 57(19%) Wilcock et al., Int Clin Psychopharmacol 2002

  4. Significant Benefit of Memantine on Cognition (ADAS-cog) ITT, LOCF ADAS-cog total score 24 25 26 27 28 29 * Decline ADAS-cog total score Memantine (20 mg/day) Placebo 0 12 28 Week * p < 0.05 versus placebo Wilcock et al., Int Clin Psychopharmacol 2002

  5. Significant Benefit of Memantine on Cognition (ADAS-cog) ITT, LOCF Mean change from baseline -2 0 2 4 Improvement * ADAS-cog score difference Memantine (20 mg/day) Placebo Decline 0 12 28 Week * p < 0.05 versus placebo Wilcock et al., Int Clin Psychopharmacol 2002

  6. Good Safety and Tolerability of Memantine Adverse events in mild to moderate VaD (MMM500) Memantine Placebo No. of patients 295 (100%) 284 (100%) No. of patients with AEs 226 (77%) 212 (75%) Dizziness 33 (11%) 23 (8%) Inflicted injury 17 (6%) 30 (11%) Confusion 22 (7%) 21 (7%) Constipation 30 (10%) 12 (4%) Bronchitis 20 (7%) 20 (7%) Headache 21 (7%) 19 (7%) Fall 18 (6%) 21 (7%) Coughing 20 (7%) 15 (5%) Agitation 11 (4%) 23 (8%) Wilcock et al., Int Clin Psychopharmacol 2002

  7. Summary • Significant cognitive benefit for memantine treated patients in mild to moderate vascular dementia • Good safety and tolerability of memantine Wilcock et al., Int Clin Psychopharmacol 2002

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