Objective: In trials evaluating rivastigmine in dementia types other than Alzheimer’s (AD), benefits in behavioural and psychological symptoms of dementia (BPSD) were demonstrated - especially in psychotic (delusions, hallucinations) and non-psychotic (activity disturbances, aggressiveness) disruptive symptoms. These results encouraged a retrospective analysis of the effects of rivastigmine in mild to moderate AD, using a pooled database of three pivotal rivastigmine studies.
Design: The original studies were double-blind, placebo-controlled, 26-week studies of rivastigmine in patients with mild to moderately severe AD (MMSE 10-26). Data were collected with the BEHAVE-AD, which formed part of the CIBIC-plus assessment. For the current analyses, the databases for these three studies were pooled.
Materials and Methods: The population for whom BEHAVE-AD data were available (n=1840) was stratified by the presence/absence of BPSD at baseline. Percentages of patients showing improvements of existing BPSD, or showing no new treatment-emergent BPSD, after 6 months of rivastigmine or placebo treatment were calculated.
Results: Baseline disruptive behaviours were very mild. Low baseline scores on the BEHAVE-AD were observed in a large proportion of patients: 63.7% had activity disturbances, 44.8% aggressiveness, 42.8% delusions, and 20.9% hallucinations (these low scores did not necessarily have to be ‘clinically significant’ for a subject to be included in this analysis). With regard to patients showing symptom improvements, rivastigmine provided statistically significant decreases over placebo on delusions and aggressiveness after 6 months. With regard to the prevention of symptom emergence, rivastigmine provided statistically significant decreases over placebo on the activity disturbances item of the BEHAVE-AD. Significant effects on hallucinations in these patients were not observed, possibly because of the small number of patients experiencing these at baseline.
Conclusion: These findings suggest that rivastigmine may have some effect on psychotic symptoms, and decrease the incidence of the emergence of non-psychotic disruptive symptoms, in patients with mild to moderate AD. The analyses were limited by the fact that patients with mild to moderate AD (which constituted the vast majority of our sample) do not generally have severe BPSD, and that patients with symptoms severe enough to require antipsychotic treatment were excluded from these studies. The findings are worthy of further investigation in prospective, controlled clinical studies.
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