Wake Forest University Baptist Medical Center is one of 34 clinical sites nationally that will conduct Alzheimer’s disease research as part of the $60 million Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE, project, one of the largest studies ever funded by the National Institute of Mental Health.
The Alzheimer’s disease arm of the CATIE project is a nationwide study of medications used to treat disruptive behaviors related to Alzheimer’s disease.
That study aims to determine the value of a new class of antipsychotic drugs that includes clozapine, risperidone, olanzapine, quetiapine and ziprasidone. All medications in the study are approved by the U.S. Food and Drug Administration.
Unlike first-generation antipsychotics, which act primarily on the brain’s dopamine system, the newer medications being studied by the CATIE project also act on serotonin and norepinephrine systems, said Deirdre Johnston, MB BCh., assistant professor of psychiatry and behavioral medicine, and the study’s principal investigator at Wake Forest.
However, the new drugs cost at least 10 times more than the first-generation antipsychotics, and their relative effectiveness is unknown. She said CATIE results will help determine if they are more effective and whether they are worth the higher price.
“It is essential that we determine which medications provide the best treatment for Alzheimer’s behavioral symptoms, such as hallucinations, aggression and agitation,” Johnston said. “The CATIE study will help us make more informed choices about treatment and, as a result, improve the quality of life for everyone affected by the illness.”
Up to 450 people with Alzheimer’s disease will participate in the CATIE study nationwide. Completion of the study is set for September 2004. Recruitment for the CATIE study will continue until Dec. 31, 2003.
While CATIE is a medication study, Johnston added that participants in the Alzheimer’s study are given comprehensive clinical care and support. In addition to receiving the medications, participants are also offered support through individual assessments.
“While November is designated as a time to increase public awareness of Alzheimer’s disease, it also marks a national effort to recognize and offer support for the caregivers of Alzheimer’s patients,” she said. “A large part of the CATIE study depends upon the caregivers. We provide support for the caregivers of our participants as well.”
The Department of Psychiatry at the University of North Carolina at Chapel Hill is the coordinating center for the CATIE project. The study is managed by Quintiles, Inc., of Research Triangle Park.
Barbara Lasater is the study coordinator and can be reached at 336-716-9234. Wake Forest University Baptist Medical Center is an academic health center including Wake Forest University School of Medicine and N.C. Baptist Hospital.
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