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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Orgogozo j m rigaud a s st ffler a m bius 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

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

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


Significant benefit of memantine on cognition adas cog

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


Significant benefit of memantine on cognition adas cog1

-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


Significant benefit of memantine on cognition mmse

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

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

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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