Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's Disease Trial

Abstract

This article describes the development of the protocol for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Alzheimer's disease trial, which was developed in collaboration with the National Institute of Mental Health to assess the effectiveness of atypical antipsychotics for psychosis and/or agitation occurring in outpatients with Alzheimer's disease. The article provides a detailed description of the methodology used in the trial as well as the clinical outcomes and effectiveness measures incorporated into it, discussing the most salient issues encountered in developing the design of the trial, as well as the unique features of the trial.

ACNP White Paper: Update on Use of Antipsychotic Drugs in Elderly Persons with Dementia

“…There is a paucity of clinical trials with psychotropics in older adults in general and in dementia patients in particular, with consequent lack of evidence-based therapeutic alternatives. Several factors contribute to this dearth of clinical trials in older adultsFfor example, pharmaceutical companies tend to shy away from studying older adults because of their increased medical comorbidity, polypharmacy, cognitive deficits, and a greater risk for most side effects (Roose and Sackeim, 2002;Ownby, 2001;Schneider et al, 2003).…”

Clinical Symptom Responses to Atypical Antipsychotic Medications in Alzheimer’s Disease: Phase 1 Outcomes From the CATIE-AD Effectiveness Trial

“…The CATIE-AD research design and methods have been described previously (16,18). Fortytwo clinical sites enrolled 421 patients who were randomized initially to masked treatment with olanzapine, quetiapine, risperidone, or placebo (2:2:2:3 ratio).…”

“…The National Institute of Mental Health (NIMH) Clinical Antipsychotic Trials of Intervention Effectiveness -Alzheimer's Disease (CATIE-AD) project was designed to compare the effectiveness of antipsychotic medications and placebo in patients with AD and psychosis or agitated/aggressive behavior (16). In contrast to typical efficacy trials, CATIE-AD included outpatients in usual care settings, and assessed treatment effectiveness on several clinical outcome measures over a nine-month intervention period.…”

Reliability and validity of the Norwegian version of the Brief Agitation Rating Scale (BARS) in dementia

“…As agitation is an outcome variable in many randomised pharmacological and non-pharmacological controlled intervention studies (Ballard et al, 2009;Cohen-Mansfield, Werner, & Marx, 1989;Kirkevold, Sandvik, & Engedal, 2004;Schneider et al, 2003), instruments that measure agitation have to be feasible, reliable and valid. Many instruments have emerged, measuring aggressive and agitated behaviours in different patient populations and in a variety of settings: the Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield, Marx, & Rosenthal, 1989), Staff Observation Aggression Scale (SOAS; Palmstierna & Wistedt, 1987), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD; Reisberg et al, 1987) Scale, the Rating Scale for Aggressive Behaviour in the Elderly (RAGE; Patel & Hope, 1992), the Present Behavioural Examination (PBE; Hope & Fairburn, 1992), the Brief Agitation Rating Scale (BARS; Finkel, Lyons, & Anderson, 1993), the Pittsburgh Agitation Scale (PAS; Rosen et al, 1994), the Overt Aggression Scale (OAS; Silver & Yudofsky, 1991;Yudofsky, Silver, Jackson, Endicott, & Williams, 1986), the Overt Aggression Severity Scale (OASS; Yudofsky, Kopecky, Kunik, Silver, & Endicott, 1997), the Neuropsychiatric Inventory (NPI; Cummings et al, 1994) and the NPI-Nursing Home (NPI-NH; Wood et al, 2000) Version.…”