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

PD-010 Risperidone is Effective in the Treatment of BPSD Irrespective of the Type and Severity of Dementia

Henry Brodaty, Academic Department for Old Age Psychiatry, Prince of Wales Hospital, Sydney, Australia, Peter De Deyn, Department of Neurology, Middelheim Hospital, Antwerp, Belgium, Ira Katz, University of Pennsylvania, Philadelphia, PA, USA, Ben Lyons, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Titusville, NJ, USA, and Grant Ko, Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, NJ, USA.

Objective: To determine the efficacy of risperidone versus placebo in the treatment of BPSD in elderly nursing-home residents with different diagnosis and severity of dementia.

Design: Pooled data from three, 12-week, randomized, controlled clinical trials including 1150 elderly patients with BPSD. The mean risperidone dose in this patient population was 1.0 mg/day.

Materials and Methods: 76%, 14% and 10% of patients were diagnosed, respectively, with Alzheimer’s Disease (AD), vascular dementia (VD) or mixed dementia (MD), as defined by DSM-IV. For the severity analysis, patients were dichotomized at baseline, on the basis of a MMSE score of £5 (49.3% and 49.8% of patients receiving placebo and risperidone) or a MMSE score of >5 (50.7% and 50.2%, respectively). BPSD were evaluated from baseline to endpoint using the Behavioral Pathology in Alzheimer’s Disease (BEHAVE-AD) total score and the Cohen-Mansfield Agitation Inventory (CMAI) total and total aggression scores.

Results: Patients diagnosed with AD and VD and receiving risperidone demonstrated a significantly greater improvement compared with placebo on BEHAVE-AD total (AD: mean change from baseline: -6.3 (SE: 0.4) vs. -3.9(0.5); p<0.001 and VD: -5.5(0.7) vs. -3.2(0.9); p=0.02), CMAI total (AD: -12.4(0.9) vs. -6.8(1.3); p<0.001 and VD: -9.8(1.6) vs. -5.4(2.3); p=0.019) and CMAI total aggression (AD: -5.1(0.5) vs. -2.2(0.7); p<0.001 and VD: -4.4(0.9) vs. -1.2(1.3); p=0.003). No significant difference between treatment groups was observed in patients diagnosed with MD (BEHAVE-AD total: -5.3(1.2) vs. -2.7(1.3); p=0.08, CMAI total: -11.6(2.6) vs. -5.8(3.3); p=0.36 and CMAI total aggression: -5.4(1.3) vs. -0.8(1.7); p=0.08), which was probably due to the small sample size (N=46 and N=77, respectively). There is no indication that the difference between risperidone and placebo varies with diagnoses (p>0.50 for all scales). Except for CMAI total aggression (p=0.68), a trial by MMSE interaction was observed,indicated by a significant effect on BEHAVE-AD (p=0.02) and CMAI total (p=0.003). However, the differences between the trials were consistent within each trial but varied in magnitude. Independent of severity of dementia, risperidone-treated patients demonstrated a greater improvement compared with placebo on BEHAVE-AD total (MMSE£5: -6.0(0.5) vs. -3.1(0.6); p<0.001, MMSE>5: -6.3(0.5) vs. -4.0(0.6); p=0.004), CMAI total (MMSE£5: -13.1(1.2) vs. -4.9(1.6); p<0.001, MMSE>5: -11.0(1.0) vs. -7.3(1.5); p=0.004) and CMAI total aggression scores, (MMSE£5: -6.6(0.7) vs. -1.6(0.5); p<0.001, MMSE>5: -3.8(0.5) vs. -1.7(0.8); p<0.001). Overall, there is no difference that the effect size between risperidone and placebo varies with severity of dementia (BEHAVE-AD total: p=0.92, CMAI total: p=0.11). There is, however, an interaction between severity and CMAI total aggression (p<0.05).

Conclusion: In elderly nursing-home residents with dementia,low-dose risperidone is effective in reducing BPSD independent of the type and severity of dementia.

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