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Randomised controlled trial.
Thirty six weeks.
Forty two sites, USA; April 2001 to November 2004.
421 outpatients diagnosed with Alzheimer’s disease (DSM-IV) or probable Alzheimer’s diagnosis (according to history, physical examination, brain imaging, and Mini-Mental State Examination (MMSE) score between 5 and 26), with delusions, hallucinations, aggression, or agitation starting after the onset of dementia, that interfered with functioning, and occurred daily in the last week or intermittently for the last 4 weeks. Exclusions: primary psychotic diagnosis (DSM-IV), delirium, or other dementia; symptoms attributable to substance abuse or disorder other than Alzheimer’s; suicidal; previous treatment with ⩾2 medications tested in this trial; not ambulatory; not living at home or …
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