Axura^® (Memantine) Shows Benefits on Both Behavioral Disturbances and Activities of Daily Living in Patients with Moderate to Severe Alzheimer’s Disease

Paris, June 23rd, 2004 – Data demonstrating significant benefits of Merz’ Alzheimer drug Axura® on both behavioral symptoms and functional capacities of patients with Alzheimer’s disease were presented today at the XXIV CINP (Collegium Internationale Neuro-Psychopharmacologicum) congress in Paris. The results were derived from the key study published in The New England Journal of Medicine, which demonstrated that memantine treatment was significantly superior to placebo treatment on cognition, function and global outcome in patients with moderate to severe Alzheimer’s disease. The present results reflect single item analyses of the Behavioral Rating Scale for Geriatric Patients (BGP) and the assessment scale for functional capacities. Treatment with Axura® is associated with a significant benefit on behavioral symptoms such as agitation and delusions compared to placebo treatment. A second single item analysis of the functional outcome demonstrated that memantine treatment reduced the deterioration in activities of daily living in comparison to placebo treatment.

“Treatment of Alzheimer’s disease should provide a benefit on burdensome symptoms for both, patient and caregiver, such as the decline of functional abilities and the increase of behavioral disturbances. The results presented here at the CINP clearly demonstrate that Axura® treatment has a positive impact on both – behavioral and functional dysfunction in patients with moderate to severe Alzheimer’s disease" said H. J. Möbius, MD, PhD, Chief Scientific Officer of Merz Pharmaceuticals. “These treatment effects may translate into an improvement of the patient’s and the caregiver’s quality of life.”

The 28-week study included 252 outpatients suffering from moderate to severe Alzheimer’s disease at 32 sites in the US. Patients included in this prospectively designed, double-blind, placebo-controlled, phase III trial, were randomized to receive either 20 mg daily memantine or placebo.

The frequency and severity of behavioral disturbances were evaluated with the Neuropsychiatric Inventory (NPI), a standard assessment scale that measures a range of common behavioral symptoms often observed in patients with Alzheimer’s disease. The NPI data were analyzed by domains. In ten of the twelve individual behavioral symptoms tested the Axura® treatment was superior to the placebo treatment. A statistically significant benefit for patients receiving Axura® compared to the placebo-treated group was observed in the domains delusions and agitation/ aggression.

Apart from behavioral disturbances Alzheimer’s disease is associated with a steady decline in functional abilities. The effects of Axura® treatment in patients with moderate to severe Alzheimer’s disease were assessed by the Alzheimer’s Disease Cooperative Study Activities of Daily Living score modified for severe dementia (ADCS-ADL₁₉). The new single item analysis demonstrates that patients treated with Axura® consistently showed a advantage over placebo in all individual items assessed. This effect was especially pronounced for the items “pays attention to conversation”, “clears a table” and “disposes of litter”.