Commonly prescribed antipsychotic medications used to treat Alzheimer's patients with delusions, aggression, hallucinations, and other similar symptoms can benefit some patients, but they appear to be no more effective than a placebo when adverse side effects are considered, according to the first phase of a large-scale clinical trial funded by the National Institutes of Health's National Institute of Mental Health (NIMH). The trial, known as the Clinical Antipsychotic Trial of Intervention Effectiveness study for Alzheimer's disease (CATIE-AD), was published in the October 12, 2006, issue of the New England Journal of Medicine.
"Antipsychotic medications have been used extensively for Alzheimer's patients without enough solid evidence of whether they are effective," said NIMH Director Thomas R. Insel, M.D. "The study has vital public health implications because it provides physicians and patients with information to more accurately weigh the medications' benefits against their drawbacks, with the needs and unique reactions of their individual patients."
The $16.9 million, five-year trial was conducted at 42 sites and included 421 people. Participants had Alzheimer's-related dementia with additional symptoms such as delusions, aggression, hallucinations, or agitation that were severe enough to disrupt their functioning. The study was aimed at patients who either lived with a family member or caregiver at home, or resided in assisted living facilities, and excluded patients who had already been confined to a nursing home. An essential component of the trial was caregiver participation. He or she provided input to the study doctors on the patient's progress and reactions to the medication.
In this first phase of the trial, patients were randomized to olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal)--all newer antipsychotic medications--or to an inactive pill known as a placebo. Lead author Lon Schneider, M.D., of
Contact: Colleen Labbe
NIH/National Institute of Mental Health