Efficacy and Safety of Memantine in Patients With Mild to Moderate
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Orgogozo J.M., Rigaud A.S., Stöffler A., Möbius H.J., and Forette F. Stroke 2002, 33:1834-1839 PowerPoint PPT Presentation


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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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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

DesignDouble-blind, randomized, placebo-controlled, multicenter study

DiagnosisProbable VaD (acc. NINDS-AIREN, HIS  5)

Age  60 (mean 76)

SeverityMMSE 12 - 20 (mean 16.9)

Dose; duration20 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


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


19

20

21

22

23

24

*

Memantine (20 mg/day)

Placebo

0

12

28

Significant Benefit of Memantine on Cognition (ADAS-cog)

ITT, LOCFADAS-cog total score

ADAS-cog total score

Worsening

Week

*p = 0.0016 versus placebo

Orgogozo et al., Stroke 2002


-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


19

18

17

16

Memantine (20 mg/day)

Placebo

*

0

28

Significant Benefit of Memantine on Cognition (MMSE)

TPP, N = 188MMSE analysis

MMSE total score

Worsening

Week

*p = 0.003 versus placebo

Orgogozo et al., Stroke 2002


Good Safety and Tolerability of Memantine

Adverse events in mild to moderate VaD (MMM300)

MemantinePlacebo

Total no. of patients165 (100%)156 (100%)

Total no. of patients with AEs117 (70.9%)104 (56.7%)

Agitation9 (5.5%) 11 (7.1%)

Confusion8 (4.8%) 8 (5.8%)

Dizziness8 (4.8%) 5 (3.2%)

Bronchitis6 (3.6%) 7 (4.5%)

Urinary Tract Infection5 (3.0%) 7 (4.5%)

Cerebrovascular Disorder6 (3.6%) 6 (3.8%)

Depression6 (3.6%) 5 (3.2%)

Diarrhoea5 (3.0%) 6 (3.8%)

Hypertension4 (2.4%) 7 (4.5%)

Inflicted Injury5 (3.0%) 6 (3.8%)

Orgogozo et al., Stroke 2002


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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