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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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 Moderate

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


Disposition of patients
Disposition of Patients Moderate

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 Moderate

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


Significant benefit of memantine on cognition adas cog1

-2 Moderate

-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 Moderate

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


Good safety and tolerability of memantine
Good Safety and Tolerability of Memantine Moderate

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


Summary
Summary Moderate

  • 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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