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Ebixa (memantine) Demonstrates Longer Term Benefits for Moderate to Severe Alzheimer's Disease Patients

First study published to demonstrate significant clinical benefits for Ebixa over one year

COPENHAGEN, DENMARK -- January 9, 2006 -- A new study, published today in Archives of Neurology is the first to demonstrate Ebixa's (memantine) clinical benefits over the longer term.(1)

This study, a 6 month open-label extension of a 28-week, randomized, double-blind, placebo-controlled trial, showed that moderate to severe Alzheimer's disease (AD) patients on Ebixa continued to experience significant cognitive, functional and global benefits over a one year period.

The high completion rate (78%) in the study, together with a rate of adverse events similar to earlier studies, confirms Ebixa as a very well tolerated and safe AD treatment.

Alzheimer's disease is a progressive neurodegenerative disease and the most common form of dementia, with approximately 24 million people suffering from dementia worldwide.(2) In the moderate to severe stages, the symptoms are more disruptive and Alzheimer's sufferers have greater difficulty coping without supervision. In severe Alzheimer's, the advanced stages of the disease, patients generally can no longer care for themselves.

The results of this study are important for Alzheimer's disease patients and their caregivers. As patient function deteriorates, the burden on caregivers increases, often resulting in caregivers being unable to cope and the patients potentially being institutionalised," said Professor Barry Reisberg, Department of Psychiatry, New York University School of Medicine, USA. "As the only licensed treatment for moderate to severe AD, the results of this study demonstrate that Ebixa has real benefits for both patients and caregivers alike, for at least 1 year."

Patients initiated on memantine during the double-blind phase appeared to maintain their treatment benefits seen over the course of the study. In addition, patients who switched from placebo to memantine treatment in the open-label extension experienced significant benefits across the cognitive, functional and global outcome measures. These results demonstrate once again the proven efficacy of Ebixa in treating the core symptoms of AD.

Moderate to severe AD, when symptoms become more pronounced, is estimated to affect 80%iii of diagnosed Alzheimer's patients. Caring for a loved one with this disabling condition, particularly as the disease progresses, is very stressful for the caregiver in all respects, and results in considerable emotional strain.

About Alzheimer's disease
Alzheimer's disease is a progressive neurodegenerative disease and is the most common form of dementia, accounting for over 60% of all dementia cases.(3) Approximately 24 million people suffer from dementia worldwide and this rate is due to increase to 80 million by 2040.(2) Symptoms include memory deterioration (cognition), inability to perform previously routine tasks (functional decline) and personality and mood changes (behaviour).

The three key stages of Alzheimer's disease are referred to as mild, moderate and severe. People with mild Alzheimer's can usually live alone and function fairly well, as a result they may not even be aware that they have Alzheimer's disease and may not have been correctly diagnosed. By the moderate stage, the symptoms are more pronounced and Alzheimer's sufferers have greater difficulty coping without some supervision. In more severe Alzheimer's, the advanced stages of the disease, patients generally can no longer care for themselves.

About Ebixa
Ebixa (memantine) is a moderate affinity NMDA (N-methyl-D-aspartate) receptor antagonist that is unique among Alzheimer's disease treatments since it targets the neurotransmitter glutamate, a chemical messenger in the brain that is involved in normal memory and learning processes. Memantine works by modulating the effect of abnormal glutamate levels in AD, leading to symptomatic benefits in cognition, behaviour, activities of daily living, and overall clinical symptom of patients' performance for patients. Ebixa is well tolerated with a side-effect profile similar to placebo and a low potential for drug to drug interactions.

In particular, Ebixa has been proven effective in treating some of the core and most distressing symptoms of AD, significantly reducing levels of agitation/aggression, delusions and irritability in patients with AD. Ebixa treated patients are three times more likely to remain independent, with caregiver time reduced by 52 hours per month, easing everyday life for patients and caregivers.(4,5)

REFERENCES:
1. Reisberg B, Doody R, Stöffler A et al. A 24-Week Open-Label Extension Study of Memantine in Moderate to Severe Alzheimer Disease. Archives of Neurology 2006;63:1-6
2. Ferri CP, Prince M, Brayne C et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005 Dec 17;366(9503):2112-7
iii. Datamonitor, 2005
3. Warner J, Butler R. Alzheimer's disease. Clinical Evidence 2000;3:419-425
4. Rive B, Vercellotto M, Delamarre Damier F et al. Memantine enhances autonomy in moderate to severe Alzheimer's disease. Int J Geriatr Psychiatry 2004;19:458-464
5. Wimo A, Winblad B, Stoffler A et al. Resource utilisation and cost analysis of memantine in patients with moderate to severe Alzheimer's disease. Pharmacoeconomics 2003;21(5):1-14


SOURCE: H. Lundbeck A/S

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