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Donepezil in the treatment of agitation in Alzheimer's disease.

By R. J. Howard, E. Juszczak, C. G. Ballard, P. Bentham, R. G. Brown, R. Bullock, A. S. Burns, C. Holmes, R. Jacoby, Toby Johnson, M. Knapp, James Lindesay, J. T. O Brien, G. Wilcock, C. Katona, R. W. Jones, J. DeCesare, Rodger M. and CALM-AD Trial Group

Abstract

Background\ud Agitation is a common and distressing symptom in patients with Alzheimer’s disease.\ud Cholinesterase inhibitors improve cognitive outcomes in such patients, but the\ud benefits of these drugs for behavioral disturbances are unclear.\ud Methods\ud We randomly assigned 272 patients with Alzheimer’s disease who had clinically significant\ud agitation and no response to a brief psychosocial treatment program to receive\ud 10 mg of donepezil per day (128 patients) or placebo (131 patients) for 12 weeks.\ud The primary outcome was a change in the score on the Cohen–Mansfield Agitation\ud Inventory (CMAI) (on a scale of 29 to 203, with higher scores indicating more agitation)\ud at 12 weeks.\ud Results\ud There was no significant difference between the effects of donepezil and those of placebo\ud on the basis of the change in CMAI scores from baseline to 12 weeks (estimated\ud mean difference in change [the value for donepezil minus that for placebo], −0.06;\ud 95% confidence interval [CI], −4.35 to 4.22). Twenty-two of 108 patients (20.4%) in the\ud placebo group and 22 of 113 (19.5%) in the donepezil group had a reduction of 30%\ud or greater in the CMAI score (the value for donepezil minus that for placebo, −0.9 percentage\ud point; 95% CI, −11.4 to 9.6). There were also no significant differences between\ud the placebo and donepezil groups in scores for the Neuropsychiatric Inventory,\ud the Neuropsychiatric Inventory Caregiver Distress Scale, or the Clinician’s Global\ud Impression of Change.\ud Conclusions\ud In this 12-week trial, donepezil was not more effective than placebo in treating agitation\ud in patients with Alzheimer’s disease. (ClinicalTrials.gov number, NCT00142324.

Publisher: Massachusetts Medical Society
Year: 2007
DOI identifier: 10.1056/NEJMoa066583
OAI identifier: oai:lra.le.ac.uk:2381/2337
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Citations

  1. (2006). A 24-week randomized, double-blind study of donepezil in moderate-to-severe Alzheimer’s disease. doi
  2. (1990). A meta-analysis of controlled trials of neuroleptic treatment in dementia. doi
  3. Assessing the impact of neuropsychiatric symptoms in Alzheimer’s disease: the Neuropsychiatric Inventory Caregiver Distress Scale. doi
  4. (2006). Cholinesterase inhibitors for Alzheimer’s disease. Cochrane Database Syst Rev doi
  5. Efficacy of donepezil on behavioural symptoms in patients with moderate to severe Alzheimer’s disease. Int Psychogeriatr 2002;14:389-404. McKeith doi
  6. (2005). Galantamine treatment of problematic behaviour in Alzheimer disease: post-hoc analysis of pooled data from three large trials. doi
  7. Global Impression of Change. Alzheimer Dis Assoc Disord 1997;11:Suppl 2:S22-S32.
  8. Gornheimer disease: a meta-analysis.
  9. (2004). Healthcare products Regulatory Agency. New advice issued on risperidone and olanzapine.
  10. (1997). Management of verbally disruptive behaviors in nursing home residents. doi
  11. (2007). Massachusetts Medical Society. All rights reserved. n engl j med 357;14 www.nejm.org october 4, 20071392 A Trial of Donepezil for Agitation in Alzheimer’s Disease thal AS. A description of agitation in a nursing home.
  12. Neuroleptic drugs in dementia: benefits and harm. doi
  13. (1990). Psychiatric symptoms and nursing home placement of patients with Alzheimer’s disease.
  14. Quetiapine and rivastigmine and cognitive decline in Alzheimer’s disease: randomised double blind placebo controlled trial. doi
  15. Ravishankar; University of Oxford,
  16. Reduction of behavioural disturbances and caregiver distress by galantamine in patients with Alzheimer’s disease. doi
  17. The impact of dementia on the family.
  18. (1997). The impact of the symptoms of dementia on caregivers. doi
  19. (2015). The New England Journal of Medicine Downloaded from nejm.org at
  20. The use of the neuropsychiatric inventory in nursing home residents: characterization and measurement. doi

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