NIMH · Questions and Answers About the NIMH Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Alzheimer's Disease Study — Phase I Results

Questions and Answers About the NIMH Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Alzheimer's Disease Study — Phase I Results
October 2006 / February 2010

1. What is the CATIE Alzheimer’s disease study?
A. The CATIE Alzheimer’s disease trial was a large-scale public health study using newer, atypical antipsychotic medications for the treatment of delusions, hallucinations, aggression and agitation that often accompany Alzheimer’s disease. Such symptoms affect more than 75 percent of the people who have Alzheimer’s disease.

The $16.9 million CATIE Alzheimer’s disease study was conducted at 42 sites with 421 participants and is one of two large-scale nationwide clinical trials funded by the NIH’s National Institute of Mental Health to examine the effectiveness of atypical antipsychotic medications. These medications were developed originally to treat symptoms (such as hallucinations and delusions) associated with schizophrenia, but they are widely used to treat similar symptoms in Alzheimer’s disease. For information relating to the CATIE Schizophrenia Study, visit the NIMH CATIE page.

2. Why is the CATIE Alzheimer’s study important?
A. Memory loss and disorientation are the most common symptoms of Alzheimer’s disease, but many people with the disease experience symptoms such as delusions, hallucinations, aggressive behavior, or agitation. These symptoms are associated with a rapid worsening of the illness and often result in the patient being placed in a nursing home or other specialized care institution.

The U.S. Food and Drug Administration (FDA) has not specifically approved antipsychotic medications for use in treating people with Alzheimer’s disease, but many doctors prescribe these medications “off label” when they believe a patient may benefit. Although many different antipsychotic medications have been used to treat these thinking and behavior symptoms in people with Alzheimer’s disease, doctors do not have data about how well they work, if some work better than others, and if they are safe. About 25 percent of Alzheimer’s patients living in nursing homes receive atypical antipsychotics.1 However, no data exist that indicate how many Alzheimer’s patients living outside of nursing home currently receive these medications.

The CATIE Alzheimer’s disease study was designed to evaluate the overall effectiveness of the newer antipsychotic medications in treating hallucinations, aggression and related symptoms. Specifically, it aimed to determine if these medications — overall — are beneficial, tolerable, and safe for use by Alzheimer’s patients. The study is unique for several reasons. Although studies of antipsychotic medications have been conducted, nearly all of those studies were conducted in nursing homes and therefore, are less relevant to the many people with Alzheimer’s disease cared for by family members in their own homes or in assisted-living facilities. Further, none of these earlier studies followed participants for longer than 12 weeks. Lastly, these earlier studies did not compare different antipsychotic medications to each other.

In contrast, the CATIE Alzheimer’s disease study included three of the most widely used antipsychotic medications and placebo (inactive pill) among patients in non-nursing home settings, who were experiencing delusions, hallucinations, aggression, or agitation. The study followed the participants over nine months and also included the involvement of caregivers.

3. Who participated in the study?
A. The 421 participants all had Alzheimer’s disease, and were geographically dispersed at 42 clinical sites across the United States. All were experiencing delusions, hallucinations, aggression, or agitation that disrupted their daily functioning, such that an antipsychotic medication was determined to be appropriate treatment. Participants were ambulatory and still living at home or in assisted living facilities. A family member, caregiver, or study partner who had regular contact with the patient also participated in the study to help with monitoring and assessments. Study staff worked closely with participants’ regular doctors to monitor co-occurring medical illnesses.

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NIMH · Questions and Answers About the NIMH Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Alzheimer's Disease Study — Phase I Results