Objective: To assess changes in motor function and risk of falls or abnormal gait in patients with Alzheimer’s dementia (AD) during treatment with olanzapine.
Design: Patients’ mean age was 76.4 years, and 75.0% were female. Mean Mini-Mental State Examination score was 13.7±5.1.
Materials and Methods: Following a placebo lead-in period (less than 14 days), 652 inpatients with AD and delusions or hallucinations were randomly assigned to one of five treatments: 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.
Results: At endpoint, patients in all five treatment groups showed slight but nonsignificant improvements from baseline on both the Simpson–Angus scale and Abnormal Involuntary Movement Scale, and incidence of treatment-emergent extrapyramidal abnormalities (akathisia, akinesia, dyskinesia, extrapyramidal syndrome, tremor) was not significantly different either among treatment groups or overall. No significant changes were seen in Simpson–Angus Gait item scores. Modified Performance-Oriented Mobility Assessment-II scores, indicative of patients’ mobility and balance, were likewise not significantly affected. Incidence of falls reported as an adverse event was 5.3% in the 7.5-mg group, 7.9% in the 5.0-mg group, 7.4% in the 2.5-mg group, 5.4% in the 1.0-mg group, and 5.4% in the placebo group (overall p=.863).
Conclusion: Olanzapine at doses of 1.0 to 7.5 mg/day had no appreciable impact on motor function or gait or cause any significant increase in the incidence of falls in elderly patients with AD.
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