Objective: Dementia is commonly associated with psychotic and behavioral symptoms, including delusions, hallucinations, and agitation. Antipsychotic and other psychotropic medications have been used to treat these symptoms with variable success. Aripiprazole, a newly developed antipsychotic, has been shown to be effective in treating psychotic symptoms in adults with schizophrenia. A clinical trial was conducted to evaluate the efficacy of aripiprazole in patients with psychosis associated with Alzheimer's dementia.
Materials and Methods: In a 10-week, multicenter, randomized trial, 208 outpatients with psychotic symptoms associated with Alzheimer's dementia (mean age 81.5 y, baseline MMSE = 14.2, score of °Ý 6 on NPI psychosis subscale), were randomized to flexible doses of aripiprazole (2 - 15 mg per day) or placebo. Dosing was initiated at 2 mg per day for the first 2 weeks, with the option to increase dose at recommended two-week intervals to 5, 10, or 15 mg per day, or more rapidly based on investigator evaluation, in the absence of clinical response and dose-limiting side effects. Efficacy was assessed by Neuropsychiatric Inventory [NPI] psychosis subscale and Brief Psychiatric Rating Scale (BPRS). Safety and tolerability of aripiprazole and placebo were also assessed.
Results: Mean dose of aripiprazole administered was 10 mg. At week 10, aripiprazole and placebo showed comparable improvement in the caregiver-rated NPI-Psychosis subscale change at endpoint (-6.55 vs ¨C5.52, p=0.17). At week 10, aripiprazole showed an improvement of ¨C8.5 in BPRS Total (p=0.15 vs placebo), while showing significant effects on BPRS psychosis (hallucinations and delusions) subscores vs placebo (-1.93 vs ¨C1.27, p=0.03) . The patient completion rate was 83% with aripiprazole and 82% with placebo and the discontinuation rate due to an adverse event (AE) was 8% vs. 7%. The most common AEs reported include: UTI (8% vs 12% placebo), accidental injury (8% vs 5%), somnolence (8% vs 1% ), bronchitis (6% vs 3%) and EPS-related events (5% vs 4%). Somnolence was mild and not associated with falls or accidental injury. There were no significant differences from placebo in potentially clinically significant ECG abnormalities, vital signs, labs or weight.
Conclusion: Aripiprazole improved symptoms of hallucinations and delusions in these largely mildly to moderately impaired community living AD patients with psychosis. Aripiprazole was safe and well-tolerated in this elderly population.
Back to Clinical neurosciences in dementia
Back to Oral and Poster Sessions
Back to The IPA European Regional Meeting (1-4 April 2003) of IPA