AXURA(R)/AKATINOL(R) Enhances Communication Abilities In Patients With Alzheimer´s Disease - for A Longer Integration In Social And Family Life

Main Category: Alzheimer's / Dementia
Article Date: 15 Jul 2009 - 1:00 PDT

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Memantine improves functional communication skills in patients with moderate to severe Alzheimer's disease (AD), noticeable by caregivers. These are the study results discussed at the International Conference on Alzheimer's Disease (ICAD). The data of two recent clinical trials support that AXURA®/AKATINOL® - an uncompetitive NMDA receptor antagonist - effects language skills in AD patients and improves cognitive abilities and functional communication. Leading neurologists emphasize that improvement of communication skills is a meaningful treatment target. Communication breakdown can trigger feelings of frustration in Alzheimer's patients and these feelings may manifest as behavioral instability. This in turn is known to be a major source of caregiver's burden and distress.

"Effective, individualized treatment of language and communication problems would prolong the patient´s ability to interact with those around them, maintain levels of social and family integration, and reduce caregiver burden", commented keynote speaker Prof. Jörg Schulz, Director of the Department of Neurology, University Hospital Aachen, Germany, on the occasion of a Merz satellite symposium held at the ICAD.(1) Memantine produced significant benefits in the treatment of language disturbance in patients with AD. In a 12-week, randomized, double-blind, placebo-controlled trial patients treated with memantine (n=120) demonstrated an improvement in functional communication measured by the Functional Linguistic Communication Inventory (FLCI) at week 12 (p=0.070) compared to the patients treated with placebo (n=131).(2) A statistically superior performance of the memantine group was observed across the entire trial. The FLCI evaluates 10 areas, e.g. greeting and naming, answering questions and following com-mands. Furthermore memantine-treated patients significantly outperformed placebo-treated patients on the combined ASHA-FACS subscales (p=0.022). The American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA-FACS) is a standardized and validated instrument to evaluate abilities in 4 areas: social communication, communication of basic needs, daily planning and reading/writing/numeral concepts. The ASHA-FACS is scored by caregivers and reflects the caregiver's perception of change in the patient's communication skills.

A 16-week, multi-national, open-label trial studied the benefit of 20 mg once-daily memantine treatment on language and communication abilities in outpatients with moderate to severe AD (n=97).(3) The primary endpoint was the baseline to 12-week total score change on the Consortium to Establish a Registry for Alzheimer's disease - neuropsychological battery (CERAD-NP). The CERAD-NP test battery is composed of 5 sub-test groups such as verbal fluency, Modified Boston Naming Test, MMSE, constructional ability and word list memory. The CERAD-NP total score improved significantly after 12 weeks of memantine treatment compared to baseline (p<0.001). A secondary endpoint was the FLCI. The FLCI score improved significantly after 12 weeks compared to baseline (p<0.001). These endpoints also showed significant improvement after 4 and 8 weeks of treatment and after 4 weeks of wash-out compared to baseline. The changes were seen as early as 4 weeks after start of treatment and persisted through a 4-week wash-out period of memantine.

Underlining the relevance of these findings Prof. Schulz explained: "Memantine has shown to improve and preserve communication skills in patients with AD. This is a meaningful treatment target that can facilitate social interaction, and benefit the daily lives of both patients and caregivers."

AXURA®/AKATINOL® has proven as a safe and tolerable treatment option with a strong impact on functional communication in Alzheimer´s patients. Improved communication skills in AD patients may reduce stress for patients and carers and keep them longer connected.

Alzheimer's disease is the most common cause of dementia and accounts for 60-70% of all cases. Alzheimer's disease is a progressive, degenerative illness that attack the brain. AD affects people's abilities in cognition, communication skills, social behavior and basic everyday activities. Thus totally deteriorating their eve-ryday competence. Currently there are an estimated 30 million people worldwide with dementia. Every year, 4.6 million new cases of dementia are reported. This is one new case every seven seconds. By 2050, it is projected that the world will be looking at 100 million people with dementia.(4) In light of this, drugs like AXURA®/AKATINOL® may represent an impactful treatment choice to efficiently face this socioeconomic challenge.

About Memantine

Memantine is an NMDA-receptor antagonist, the first in a class of AD medications with a unique mechanism of action that focuses on the glutamatergic system. Glutamate is the most common excitatory neurotransmitter in the CNS and the modulation of the glutamatergic neurotransmission is a major target for the treatment of Alzheimer's disease.

Memantine was developed by Merz and licensed to Forest for the U.S. and Lundbeck for selected European and international markets. Memantine is marketed under the brands Axura® and Akati-nol® by Merz, Namenda® by Forest and Ebixa® by Lundbeck.

References

1. Satellite symposium "From clinical trials to real-life settings: is there a link?" held at the Alzheimer´s Association International Conference on Alzheimer´s Disease 2009, Vienna, Austria, July 13, 2009.

2. Hofbauer, Robert K. et al. "Effects of Memantine on Functional Communication in Patients with Moderate AD: Results of a 12-week Placebo-Controlled Trial", poster presented at the Alzheimer´s Association International Conference on Alzheimer´s Disease 2009, Vienna, Austria, July 11-16, 2009.

3. Schulz, Jörg B. et al. "Once-daily memantine treatment improves cognition and functional communication in patients with moderate to severe AD: Results of a 16-week open-label trial", poster presented at the Alzheimer´s Association International Conference on Alzheimer´s Disease 2009, Vienna, Austria, July 11-16, 2009.

4. Alzheimer's Disease International (ADI), http://www.alz.co.uk.

Source
Merz Pharmaceuticals GmbH

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