Objective: The NIMH-sponsored Clinical Antipsychotic Trial of Intervention Effectiveness – Alzheimer’s Disease (CATIE-AD) is a multicenter effectiveness trial, assessing multiple outcomes over 9 months in 450 outpatients with AD who might benefit from atypical antipsychotics.
Design and Methods: The sequential ‘hybrid’ design combines elements of efficacy trials with effectiveness trials to assess the comparative outcomes of risperidone, olanzapine, and quetiapine, and, at a second level, the likelihood of response to a subsequent antipsychotic or to citalopram in patients who did not respond to initial treatment. The trial is designed to model clinical practice, requiring considerable involvement by the clinician-investigator with respect to treatment decisions regarding randomized and double-blinded medications. Its design takes advantage of the uncertainty principle and the concept of clinical equipoise in assessing the non-superiority of the intervention algorithms.
Results: In this presentation we will first describe the protocol, barriers to recruitment, inter-site variability, and the characteristics of the first 267 patients randomized. Their age range is 52-105 years (mean 78.0); 57% are female; 58% are married; 33% are widowed, 72% are living at home; 8% are living in an assisted living facility; and 20% are minorities. Participants represent the full range of dementia severity with a mean MMSE of 14.5. About 25% are severely, two-thirds are moderately, and the rest mildly demented. Our presentation will also highlight some of the variations in clinical practice and clinical research encountered in this trial, such as relatively brief periods of medication exposure prior to switching therapies.
Conclusion: The CATIE-AD protocol mirrors clinical practice and demonstrates that an effective trial is feasible.
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