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Rivastigmine Shows Sustained Efficacy in Alzheimer's Patients: Presented at CINP

By Jill Stein

PARIS, FRANCE -- June 21, 2004 -- Rivastigmine helps postpone cognitive worsening in patients with Alzheimer's disease (AD) for up to 4 years, regardless of baseline disease status.

The findings were presented here on June 21th at the XXIV Collegium Internationale Neuro-psychopharmacologicum Congress.

Daniel Kaufer, MD, Associate Professor of Neurology, University of North Carolina in Chapel Hill, presented a pooled analysis of data from 2 large open-label extension studies that compared patients with AD who had completed 4 double-blind, randomized, placebo-controlled trials of treatment with rivastigmine, a dual inhibitor of acetyl- and butyrl-cholinesterase. Overall, 2010 patients were included in the analysis.

Patients were stratified by AD severity according to baseline Global Deterioration Scale (GDS) scores, and changes in Mini-Mental State Examination (MMSE) scores over four years were calculated.

Since there were no placebo arms in the extension studies, an algorithm was used to project cognitive decline had patients been left untreated. The mean MMSE score at enrollment was 19.3.

According to baseline GDS scores, the number of patients with mild dementia (GDS 3 9or less), moderate (GDS 4), and moderately severe (GDS 5 or greater) at baseline were 570, 744, and 671, respectively.

Using the model-based projections for 'untreated' patients, the extent of cognitive decline for patients in each subgroup remaining on treatment for 4 years would have been 50% to 70% greater than if they had received rivastigmine. Dr. Kaufer noted that a separate analysis that adjusted for baseline status of patients remaining at each visit showed similar findings.

The greatest treatment effects were observed in patients with moderate or moderately severe AD who, according to the model, showed the greatest decline during the study if left untreated.

"If confirmed in follow-up trials, the delay of cognitive decline associated with rivastigmine would be clinically significant since, according to current guidelines, once MMSE levels decline below the UK National Institute of Clinical Excellence limit of 12, patients are no longer considered eligible for cholinesterase inhibitor treatment," Dr. Kaufer commented.

If confirmed, the observation that rivastigmine is more effective in patients with more severe cognitive symptoms would suggest that the National Institute of Clinical Excellence threshold for eligibility should be lowered to ensure that paints with more severe symptoms can benefit from cholinesterase inhibitor treatment, he added.

The study was sponsored by Novartis Neuroscience.


[Presentation title: "Efficacy of Rivastigmine Over 4 Years in Mild, Moderate and Moderately Severe Alzheimer's Disease." Abstract #P01.299]

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