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A Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole for the Treatment of Psychosis in Nursing Home Patients with Alzheimer Disease

From the Section on Geriatric Psychiatry, University of Pennsylvania, Philadelphia, PA (JES); VISN 4 Mental Illness Research Education & Clinical Center, Philadelphia Veteran Affairs Medical Center, Philadelphia, PA (JES); Program in Neurobehavioral Therapeutics to Alzheimer’s Disease Care, Research and Education Program (AD-CARE), Rochester, NY (APP); Bristol-Myers Squibb Company, Wallingford, CT (CDB, Marcus); Bristol-Myers Squibb Company, Braine l’Alleud, Belgium (RS); Otsuka America Pharmaceutical Inc., Princeton, NJ (McQuade, WHC).

Objective: To evaluate the efficacy and safety of aripiprazole treatment for psychotic symptoms associated with Alzheimer disease (AD).

Methods: In this parallel group, randomized, double-blind, placebo-controlled, flexible-dose trial, institutionalized subjects with AD and psychotic symptoms were randomized to aripiprazole (n = 131) or placebo (n = 125) for 10 weeks. The aripiprazole starting dose was 2 mg/day, and could be titrated to higher doses (5, 10, and 15 mg/day) based on efficacy and tolerability.

Results: No significant differences in mean change [2 x SD] from baseline between aripiprazole (mean dose 9 mg/day at endpoint; range = 0.7–15.0 mg) and placebo were detected in the coprimary efficacy endpoints of Neuropsychiatric Inventory–Nursing Home Version (NPI-NH) Psychosis score (aripiprazole, –4.53 [9.23]; placebo, –4.62 [9.56]; F = 0.02, df = 1, 222, p = 0.883 [ANCOVA]) and Clinical Global Impression (CGI)–Severity score (aripiprazole, –0.57 [1.63]; placebo, –0.43 [1.65]; F = 1.67, df = 1, 220, p = 0.198 [ANCOVA]) at endpoint. However, improvements in several secondary efficacy measures (NPI-NH Total, Brief Psychiatric Rating Scale Total, CGI – improvement, Cohen–Mansfield Agitation Inventory and Cornell Depression Scale scores) indicated that aripiprazole may confer clinical benefits beyond the primary outcome measures. Treatment-emergent adverse events (AEs) were similar in both groups, except for somnolence (aripiprazole, 14%; placebo, 4%). Somnolence with aripiprazole was of mild or moderate intensity, and not associated with accidental injury. Incidence of AEs related to extrapyramidal symptoms was low with aripiprazole (5%) and placebo (4%).

Conclusions: In nursing home residents with AD and psychosis, aripiprazole did not confer specific benefits for the treatment of psychotic symptoms; but psychological and behavioral symptoms, including agitation, anxiety, and depression, were improved with aripiprazole, with a low risk of AEs.

Key Words: Aripiprazole • Alzheimer disease • dementia • behavioral symptoms • psychotic symptoms

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				H. Lavretsky Neuropsychiatric Symptoms in Alzheimer Disease and Related Disorders: Why Do Treatments Work in Clinical Practice but Not in the Randomized Trials? Am J Geriatr Psychiatry, July 1, 2008; 16(7): 523 - 527. [Full Text] [PDF]