Positive effects of Ebixa (memantine) treatment in Alzheimer's disease, New data

New results from a study assessing patients switched from an acetylcholinesterase inhibitor to Ebixa and results from an
open label naturalistic study -


Lundbeck announced results from two independent studies demonstrating the efficacy and tolerability of Ebixa in the treatment
of Alzheimer's disease (AD) patients at the 7th International Conference on Alzheimer's and Parkinson's Disease (AD/PD 2005)
in Sorrento, Italy. The placebo controlled study results demonstrated that in moderate to severe Alzheimer's patients for
whom treatment was switched either abruptly or gradually from donepezil to Ebixa, the switch was found to be well tolerated
with the majority of patients maintained or improved in their global performance. The results from an open label naturalistic
study showed that Ebixa treatment led to clinical improvements in Alzheimer's disease patients.


"Previous data has indicated potential withdrawal reactions to the interruption of acetylcholinesterase inhibitor treatment
in Alzheimer's patients, characterised by global patient deterioration." said Anders Gersel Pedersen, head of drug
development at Lundbeck. "These results show that Alzheimer's patients, who were switched either abruptly or gradually to
Ebixa treatment from donepezil, did not experience tolerability problems and that the majority of these patients stabilised
or improved with Ebixa treatment. In addition, the open label study further supports Ebixa's efficacy and favourable
tolerability, as previously reported in randomised clinical studies."


Study 1: Switching to memantine in AD


Results from a double-blind, placebo controlled study in forty six patients with moderate to severe Alzheimer's disease (mean
MMSE < 14) conducted in Scandinavia, showed that switching from the acetylcholinesterase inhibitor donepezil to memantine is
well tolerated. Patients who appeared to be no longer benefiting from donepezil treatment, were randomised to either a
placebo group, with their current donepezil 10 mg therapy discontinued abruptly, or a gradual down-titration group, with
their current donepezil therapy discontinued in a stepwise programme, down-titrating donepezil from 10 mg to 5 mg for two
weeks before discontinuing. At the same time, memantine was up-titrated to 20mg/day over a three-week period for both
patient groups. The adverse events reported in either group were considered mild to moderate by the investigator and there
were no clinically relevant differences in tolerability between the abrupt and stepwise switching schedules respectively.



In addition, switching from donepezil to memantine appeared to maintain or improve patients' global performance, with 74% of
the patients either stabilising or improving as measured by Clinician's Global Impression of Change (CGI-C) after being
switched to memantine.















Study 2: Efficacy and tolerability of memantine in a naturalistic setting


Open label data from a large naturalistic study in 1,845 Alzheimer's disease patients in Germany were also presented at the
AD/PD conference today. Alzheimer's disease patients were treated for six months with memantine (20mg/day). Cognitive
function assessment as measured by the Mini Mental State Examination (MMSE), and other measures such as the Nurses'
Observation Scale for Geriatric Patients (NOSGER measure of behaviour and function), the Explorations Modul Demenz (EMD
measure of cognition, function and insight) and a rating of global efficacy by the clinician were recorded at baseline and at
six months.


After six months of open label treatment with memantine, patients' cognitive function was statistically significantly
improved by a mean of 2.5 MMSE points (p