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Title: Galantamine Effective, Well Tolerated in Patients With Alzheimer's Disease Unresponsive to Other Antidementia Medications: Presented at EFNS

"Galantamine Effective, Well Tolerated in Patients With Alzheimer's Disease Unresponsive to Other Antidementia Medications: Presented at EFNS"

By Chris Berrie BRUSSELS, BELGIUM -- August 29, 2007 -- The acetylcholinesterase inhibitor (AChI) and nicotinic receptor modulator galantamine is efficacious and well tolerated in patients with mild to moderate Alzheimer's disease (AD) who have previously not tolerated or not responded to other antidementia drugs, say researchers. With many patients with Alzheimer's disease who show intolerance or nonresponsiveness to specific anti-dementia drugs, evidence is emerging that transition to another medication may well provide further benefits. The findings of this open-label, prospective, noninterventional trial were presented here by Bernd Ibach, MD, PhD, Principal Investigator and Medical Development Manager, Medical and Scientific Affairs, Janssen-Cilag GmbH, Neuss, Germany, on August 27th at the 11th Congress of the European Federation of Neurological Societies (EFNS). This study was designed to assess the effectiveness and tolerability of galantamine in patients with mild to moderate AD who had already undergone transition(s) among other antidementia drugs. Here, 279 patients were enrolled (mean age, 75.4 years; male, 45%) through private practices in Germany, who showed an International Classification of Diseases (ICD)-10 research criteria severity of dementia of either mild (48%) or moderate (52%). Dr. Ibach explained, "What we have done here is to look if the results from the controlled trials with high internal relevancy can also be extrapolated to clinical practice and high everyday, external relevancy." The previous antidementia treatments that this patient group had used included memantine (15.7%), gingko biloba and piracetam (64.3%), and the AChIs donepezil and rivastigmine (34.4%). The main reasons for patient withdrawal from these previous treatments were lack of efficacy or tolerability. These patients were transferred to galantamine (8-24 mg/day) and observed for a period of 6 months. The clinical assessments of efficacy were based on the DemTect score (range, 0-18), the Nurses' Observation Scale for Geriatric Patients (NOSGER) (30 items, comprising activities of daily living, memory, mood, and behaviour), the Zarit Burden Interview (ZBI) (22 items, to assess caretaker burden), and the Clinical Global Impression (CGI). After a mean treatment period of 159 days, the mean DemTect score showed a significant improvement from 7.2 to 8.2 ([P <.0001). This was seen as 50.3% of the patients who showed improved DemTect scores, and 16.8% who remained stable.

Of note, the breakdown of the DemTect score changes according to the previous use of antidementia drugs showed clinical responses to galantamine for 70% of patients previously on memantine, 82.6% for those previously on nootropics, and 72.1% for those previously on other AChIs.

The mean NOSGER scores did not show any significant changes over the galantamine treatment period (stable at 2.4), with the exception of a significantly enhanced mean mood score (from 2.3 to 2.2). The mean ZBI scores also remained unchanged over the galantamine treatment period (1.1).

In contrast to the NOSGER and ZBI, the CGI showed improvement or stabilisation for >70% of patients during the galantamine treatment; only 13.3% of patients showed a deterioration in their CGI.

For the safety and tolerability analysis over this galantamine treatment period, 35% of patients experienced at least one adverse event (AE), with 10.1% discontinuing due to AEs. The most frequent AEs (>5%) were nausea, agitation, and dizziness.

Serious AEs were experienced by 8.2% of the patients, 8.7% (2 patients) of which were considered to be possibly related to treatment; one of these resulted in death due to a fall with traumatic brain injury.

These data thus go further toward supporting the concept that when treatment of patients with Alzheimer's disease with one antidementia drug proves not to be tolerated or not to provide benefits, these problems can often be overcome by switching patients to alternative antidementia drugs; galantamine should thus be added to the list of potential switch drugs, particularly when its dual AChI and nicotinic receptor actions are considered.

At the same time, the present study also confirms the effectiveness and tolerability of galantamine in these pretreated patients with mild to moderate Alzheimer's disease in the setting of the doctors' clinic.

This study was sponsored by Janssen-Cilag.

[Presentation title: Effects of Galantamine in Patients With Alzheimer's Disease (AD) Previously Treated With Antidementive Drugs in Germany: A Non-Interventional Trial. Abstract P2099]

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