wilcock g., möbius h.j. and stöffler a. on behalf of the mmm500 group
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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
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
Study Design
Wilcock et al., Int Clin Psychopharmacol 2002
Disposition of Patients
Wilcock et al., Int Clin Psychopharmacol 2002
Patients screenedN = 840
Patients randomizedN = 579
Screen failuresN = 261 (31%)
CompletedN = 226(80%)
WithdrewN = 58(20%)
PlaceboN = 284 (49%)
MemantineN = 295 (51%)
CompletedN = 238(81%)
WithdrewN = 57(19%)
24
25
26
27
28
290 12 28
Week
Dec
line
ITT, LOCF ADAS-cog total score
Significant Benefit of Memantine on Cognition (ADAS-cog)
Wilcock et al., Int Clin Psychopharmacol 2002
* p < 0.05 versus placebo
*
AD
AS
-cog
tot
al s
core
Memantine (20 mg/day)
Placebo
-2
0
2
40 12 28
Week
ITT, LOCF Mean change from baseline
Wilcock et al., Int Clin Psychopharmacol 2002
* p < 0.05 versus placebo
*
Significant Benefit of Memantine on Cognition (ADAS-cog)
AD
AS
-cog
sco
re d
iffer
ence
Dec
line
Impr
ovem
ent
Memantine (20 mg/day)
Placebo
Good Safety and Tolerability of Memantine
Adverse events in mild to moderate VaD (MMM500)
Wilcock et al., Int Clin Psychopharmacol 2002
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%)
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