Objective: Psychotic symptoms and behavioral disturbances are a major concern in the care of elderly patients with Alzheimer’s dementia (AD).
Design: Following a placebo lead-in period (£14 days), inpatients in long-term or continuing-care (nursing home, hospital) settings and diagnosed with AD and delusions or hallucinations were randomly assigned to receive placebo (N=129) or olanzapine at a daily fixed dose of 1.0 mg (N=129), 2.5 mg (N=135), 5.0 mg (N=127), or 7.5 mg (N=132) 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 Mini-Mental State Examination (MMSE) score was 13.7±5.1.
Results: Relative to placebo (19.4%), significantly fewer patients who received 2.5-mg (8.2%, p=.011), 5.0-mg (8.8%, p=.019), or 7.5-mg (6.1%, p=.001) olanzapine discontinued due to lack of efficacy. At endpoint, significant decreases from baseline in the NPI/NH Psychosis Total (Delusions+Hallucinations) were seen in all five treatment groups (p<.001). Repeated-measures analysis showed no significant differences among treatment groups at the 10-week endpoint, but last-observation-carried-forward decreases in the 7.5-mg olanzapine group were significantly greater than placebo (p=.008), and median time to response (³30% improvement in Psychosis Total) was significantly shorter (15.0 versus 29.0 days, p=.020). Changes in extrapyramidal measures and cognition were not significant in any treatment group. No treatment-emergent adverse events occurred with a significantly higher incidence in any olanzapine group relative to placebo. Mean changes from baseline in glucose, triglyceride, and cholesterol levels were not significantly different across treatment groups, and no clinically relevant significant changes were seen across groups in any other vital sign or laboratory measure.
Conclusion: These data indicate that olanzapine at 7.5 mg/day is well tolerated and effective for treatment of psychotic symptoms associated with AD.
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