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Lookup NU author(s): Dr Clive Ballard, Dr Maria Margallo-Lana, Simon Douglas, Dr Alan Swann, Professor Alan ThomasORCiD, Professor John O'Brien, Clare Maddison, Ruth Elvish
Objectives: To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive performance. Design: Randomised double blind (clinician, patient, outcomes assessor) placebo controlled trial. Setting Care facilities in the north east of England. Participants: 93 patients with Alzheimer's disease, dementia, and clinically significant agitation. Intervention: Atypical antipsychotic (quetiapine), cholinesterase inhibitor (rivastigmine), or placebo (double dummy). Main outcome measures: Agitation (Cohen-Mansfield agitation inventory) and cognition (severe impairment battery) at baseline and at six weeks and 26 weeks. The primary outcome was agitation inventory at six weeks. Results: 31 patients were randomised to each group, and 80 (86%) started treatment (25 rivastigmine, 26 quetiapine, 29 placebo), of whom 71 (89%) tolerated the maximum protocol dose (22 rivastigmine, 23 quetiapine, 26 placebo). Compared with placebo, neither group showed significant differences in improvement on the agitation inventory either at six weeks or 26 weeks. Fifty six patients scored > 10 on the severe impairment battery at baseline, 46 (82%) of whom were included in the analysis at six week follow up (14 rivastigmine, 14 quetiapine, 18 placebo). For quetiapine the change in severe impairment battery score from baseline was estimated as an average of -14.6 points (95% confidence interval -25.3 to -4.0) lower (that is, worse) than in the placebo group at six weeks (P = 0.009) and -15.4 points ( -27.0 to -3.8) lower at 26 weeks (P = 0.01). The corresponding changes with rivastigmine were -3.5 points ( -13.1 to 6.2) lower at six weeks (P = 0.5) and -7.5 points (-21.0 to 6.0) lower at 26 weeks (P = 0.3). Conclusions: Neither quetiapine nor rivastigmine is effective in the treatment of agitation in people with dementia in institutional care. Compared with placebo, quetiapine is associated with significantly greater cognitive decline.
Author(s): Ballard C, Margallo-Lana M, Juszczak E, Douglas S, Swann A, Thomas A, O'Brien J, Everratt A, Sadler S, Maddison C, Lee L, Bannister C, Elvish R, Jacoby R
Publication type: Article
Publication status: Published
Journal: British Medical Journal
Year: 2005
Volume: 330
Issue: 7496
Pages: 874-877
Print publication date: 18/04/2005
Date deposited: 13/10/2010
ISSN (print): 0959-8138
ISSN (electronic): 1756-1833
Publisher: BMJ Group
URL: http://dx.doi.org/10.1136/bmj.38369.459988.8F
DOI: 10.1136/bmj.38369.459988.8F
PubMed id: 15722369
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