memantine in clinical practice – results of an observational study calabrese p., essner u. and...

Memantine in Clinical Practice – Results of an Observational Study

Calabrese P., Essner U. and Förstl H.

Dementia and Geriatric Cognitive Disorders 2007; 24: 111-117

No. of patients N = 1845

Diagnosis moderate to severe Alzheimer’s disease (based on ICD-10 criteria)

Design Open-label, multicenter, post-marketing observational study

Dose; duration 20 mg memantine/day; 6 months

Outcome measures MMSE, NOSGER, EMD (“Explorationsmodul Demenz”) Overall clinical impression, cognition and activities of daily living (rated by physician) Safety and tolerability

Study Design

Calabrese et al., Dement Geriatr Cogn Disord 2007

Baseline Characteristics

Gender, female 58.2%

Mean age,years (±SD) 76.3 (± 8.7)

Mean height,cm (±SD) 167.1 (± 8.1)

Mean weight, kg (±SD) 70.3 (± 11.5)

MMSE score, mean (±SD) 15.4 (± 5.7)

Mean duration of AD,years (±SD) 2.4 (± 1.9)

Memantine


Concomitant Diseases and Comedication

Hypertension 44.5

Heart failure 24.0

Arteriosclerosis 19.7

Other cardiac diseases 2.6

Diabetes mellitus 17.2

Other 22.4

Concomitant disease % patients


Comedication % patients

Antihypertensive drugs 41.2

Antidiabetic drugs 13.4

Antidepressants 11.3

Neuroleptic drugs 9.3

5 10 15 20 25

Significant Improvement of Mean MMSE Scores after 3 and 6 Months

Baseline

3 months

Mean MMSE score

*

* p < 0.0001 vs baseline

*6 months

OC analysis


5 10 15 20 25

Responder Analysis – Stabilization and Improvement under Memantine

Proportion of patients (%)


30 35 40

6 points improvement

3-6 points improvement

1-2 points improvement

Stabilization

68.2% of patients showed improvement

MM

SE

Sco

re

Significant Improvement in All Items of the NOSGER Score

Memory

Instrumental Activities of Daily Living

Activities of Daily Living

Mood

Social Behavior

Disruptive Behavior

0 -0.2 -0.4 -0.6 -1.0 -1.2 -0.8 -1.4 -1.6

Improvement

Mean change from baseline

NOSGER score difference


p < 0.0001 vs baseline for all items at 3 and 6 months

3 months 6 months

Significant Improvement in EMD Total Score (Patient and Caregiver)

Area A+B

Area A

Area B

Area C

10 9 8 7 5 4 6 3 1

ImprovementMean EMD score

* p < 0.0001

2 0

Area A+B

Area A

Area B

Area C

Pat

ient

Car

egiv

er

*

Baseline 6 months


Area A = cognitionArea B = everyday behavior and affectivityArea C = disease-related self-awareness

10 20 30 40

Overall Clinical Impression: Improvement or Stabilization after 6 Months under Memantine



50

Improvement

Stabilization

Deterioration

No answer

78.8% of patients improved or stabilized

Positive Effect of Memantine Treatment on Cognition and Function after 6 months of treatment

Good/Very Good

Moderate

Poor

0 10 20 30 40 50


Cognition Daily functioning


Safety and Tolerability

Restlessness 0.5

Dizziness 0.4

Pneumonia 0.4

Deterioration of AD 0.4

Confusion 0.3

Cerebrovascular events 0.3

Heart failure 0.3

Aggression 0.3

Dehydration 0.3

Nausea 0.2

Paranoia 0.2

Agitation 0.2

Urinary tract infection 0.2

Adverse event % patients


Summary

• This study demonstrated memantine’s efficacy and safety in a real world patient population over six months of treatment

Significant improvement on the MMSE Score (2.5 points on average)

Improvement in memory, activities of daily living and behavior as assessed by the NOSGER

These effects were also visible to the treating physician, proven by the global assessments

• This observational study confirms the efficacy of memantine already seen in placebo-controlled clinical studies

• Memantine showed an excellent safety and tolerability profile

74.4% patients had concomitant diseases with 65.4% receiving corresponding comedication

None of the individual AEs occurred at a higher frequency than 0.5%

• These findings demonstrate the relevance of memantine’s efficacy in every day practice


memantine in clinical practice – results of an observational study calabrese p., essner u. and...

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