Regular Research ArticlesBrief Psychosocial Therapy for the Treatment of Agitation in Alzheimer Disease (The CALM-AD Trial)
Section snippets
METHODS
The original trial design was a multicenter 12-week blinded randomized three-arm (risperidone, donepezil, or placebo) parallel group clinical trial, preceded by 4 weeks psychosocial treatment. Recruitment started in November 2003 but was suspended on March 8, 2004, after the release of advice by the United Kingdom Committee for Safety of Medicines that the atypical antipsychotics risperidone and olanzapine should not be used for the treatment of behavioral symptoms in dementia because of
RESULTS
Five hundred nine patients were identified as eligible between November 2003 and December 2005, of whom 87 patients (17.1%) did not give consent for inclusion beyond initial screening and 35 preceded directly to the randomized controlled trial of donepezil, either because of the perceived severity of the agitation (N = 18) or because people were living in their own homes (N = 17). Three hundred eighty-seven patients entered the BPST phase of the study of whom 318 patients (82%) completed the
DISCUSSION
There was a significant 5.6 point reduction in the total CMAI in the 318 patients completing BPST and a similar 6.6 point reduction in the total CMAI in the 198 patients where more detailed evaluation of the quality of the BPST was possible, with 43% of patients experiencing a 30% improvement in their level of agitation. Significant improvement was evident in each of the major agitation syndromes, including aggression, restlessness, and nonaggressive verbal agitation. In the absence of a
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This work was supported by the Medical Research Council (UK), the Alzheimer's Society (UK), and Department of Health (the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health).
Study Centers: Section of Old Age Psychiatry, Institute of Psychiatry, King's College London (Julia DeCesare and Michaela Rodger Trial Managers, Dr. Louisa Beckford, Dr. Lydia Chambers, Gaynor Vere, Angela Snook, Amy Langman, Anna Oldershaw); Queen Elizabeth Psychiatric Hospital, Birmingham (Dr. Rhiannon Callaghan, Jan Wright, Analisa Smythe); Leicester (Sarah Baillon, Dr. Darren Malone, Penny Wakefield); Division of Psychiatry, University of Manchester, Wythenshawe Hospital, Manchester (Deborah Duignan, Dr. Salman Karim); Institute for Ageing and Health, Newcastle (Leslie Lee, Ruth Elvish, Dr. Mani Krishnan, Cassie Partington, Gemma Hunter, Dr. Mani Bhasin, Dr. Anuna Ravishankar); Oxford (Mary Clarke, Lesley Daniels); Memory Assessment and Research Centre, Southampton (Christine Dean, Elizabeth Finbow); Kingshill Research Centre, Victoria Hospital, Swindon. MRC Clinical Trials Unit: Sinead Nally, Susan Tebbs, Angela, Poland, Debbie Johnson.