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Rivastigmine May Slow Progression of Moderately Severe Alzheimer's Disease

Cholinesterase (ChE) inhibitors, generally reserved for use in patients with mild to moderate symptoms of Alzheimer's disease (AD), may also be effective in patients with moderately severe disease, according to a new analysis.

In order to assess the cognitive performance, behaviour, and ability to perform activities of daily living (ADL) in patients with moderately severe AD who are treated with either rivastigmine, a dual ChE inhibitor, A. Burns, of the University of Manchester, Wythenshawe Hospital, Manchester, United Kingdom, performed a retrospective pooled data analysis of AD patients enrolled in 3 randomised, double-blind, placebo-controlled, 6-month trials.

This analysis focused on patients who received 6 to 12 mg of rivastigmine daily. Mental impairment at baseline was measured according to the Mini-Mental State Examination (MMSE) and patients with the greatest impairment, (MMSE scores between 10-12) were included in the analysis.

Of the 2126 patients with AD enrolled in the 3 trials, 117 patients filled the criteria for analysis. Sixty-two of the patients were treated with rivastigmine 6 to 12mg/day and 55 received placebo. The mean dose of rivastigmine in the treatment group was 9mg/day at the end of the trial.

Cognitive function improved slightly relative to baseline (0.2 points) in patients after 26 weeks of treatment with rivastigmine, as measured by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog). Patients in the placebo group had a mean decline of 6.3 points. MMSE after 26 weeks in the rivastigmine group declined -0.8 points compared with -2.5 points in the placebo group. Performance of ADLs in the rivastigmine group declined 2.0 points on a 6-item score while the mean decline among placebo patients was 6.3 points (P = .065) using an intention-to-treat analysis.

Patients treated with rivastigmine showed a statistically significant reduction in aggressiveness after 26 weeks (P = .023) in observed treatment cases.

Nausea, vomiting, and anorexia were common side effects of rivastigmine, which was discontinued in 61.3% of patients. Placebo was discontinued in 67.3% of patients.

Rivastigmine is effective in patients with more severe AD, the authors conclude, although they caution that their conclusion is based on a small number of patients.

The study was sponsored by Novartis, the manufacturer of rivastigmine.

Int J Geriatr Psychiatry 2004 Mar;19:3:243-9. "Efficacy of rivastigmine in subjects with moderately severe Alzheimer's disease"

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