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Time to discontinuation similar for atypical antipsychotic drugs and placebo in people with Alzheimer’s disease

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Q What is the safety and efficacy of atypical antipsychotic medications in outpatients with Alzheimer’s disease?


Embedded ImageDesign:

Randomised controlled trial.

Embedded ImageAllocation:


Embedded ImageBlinding:

Double blind.

Embedded ImageFollow-up period:

Thirty six weeks.

Embedded ImageSetting:

Forty two sites, USA; April 2001 to November 2004.

Embedded ImagePatients:

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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  • For correspondence: Dr Schneider, Keck School of Medicine, University of Southern California, 1510 San Pablo Street, HCC 600, Los Angeles, California 90033, USA; lschneid{at}

  • Source of funding: National Institute of Mental Health, USA.


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