Thursday, 21 August 2003
This presentation is part of : Thursday Poster Sessions

PD-028 Cognitive Function in Patients with Alzheimer’s Dementia During Double-Blind Treatment of Psychosis with Olanzapine

Donald P. Hay1, Walter Deberdt1, Peter P DeDeyn2, Manuel M Carrasco3, Claude Jeandel4, Peter D. Feldman1, Carrie A. Young1, Deborah L Lehman1, and Alan Breier1. (1) Neuroscience, Eli Lilly and Company, Indianapolis, IN, USA, (2) Neurology, University of Antwerp, Antwerp, Belgium, (3) Clinica Psiquiatrica Padre Menni, Pamplona, Spain, (4) Internal Medicine & Geriatric Service, CHU Hôpital La Colombière, Montpellier, France

Objective: The efficacy of atypical antipsychotic medications in reducing psychotic symptoms is well established, but their potential effects on cognition in patients with Alzheimer’s dementia (AD) are less well characterized.

Design: Following a placebo lead-in period (£14 days), 652 inpatients diagnosed with AD and delusions or hallucinations were randomly assigned to one of five treatment groups: placebo or olanzapine at fixed doses of 1.0, 2.5, 5.0, or 7.5 mg/day for up to 10 weeks of double-blind treatment.

Materials and Methods: Patients’ mean age was 76.6 years, and 75.0% were female. Mean latency from onset of dementia was 49.2±35.7 months. Mean Mini-Mental State Examination (MMSE) score was 13.7±5.1. At endpoint, mean MMSE scores (last observation carried forward) were increased slightly from baseline, significantly so in the 2.5-mg olanzapine group (+0.6±2.8, p=.019).

Results: Overall, however, no treatment-group comparisons with placebo were significant. Similarly, on the Severe Impairment Battery total scale, no significant overall treatment-group differences were seen (p=.618). Mean daily use of benzodiazepines was not significantly different across treatment groups (p=.477). No treatment-emergent adverse events occurred with a significantly higher incidence in any olanzapine group relative to placebo. As adverse events, the incidences of confusion (0.7% to 0.8%, overall p>.99), sedation (0.0% to 1.5%, overall p=.230), and somnolence (0.8% to 3.8%, overall p=.261) were not significantly different among treatment groups.

Conclusion: These data indicate that olanzapine at doses of 1.0 to 7.5 mg/day has no discernible worsening effect on cognition in elderly patients with AD.

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