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Aripiprazole Effective in Reducing Psychotic Symptoms Associated with AD-related Dementia: Presented at AAGP

By Bonnie Darves

HONOLULU, HA -- March 6, 2003 -- The new anti-psychotic aripiprazole may improve such severe and debilitating symptoms as hallucinations and delusions in outpatients with mild to moderate Alzheimer's disease-related dementia, according to a study presented here March 3^rd at the Annual Meeting of the American Association for Geriatric Psychiatry.

The findings are promising given that aripiprazole's efficacy in treating schizophrenia has been well documented but little research has been done on its efficacy in AD-related psychosis, said lead study author Peter De Deyn, MD, a neurologist at the University of Antwerp Middleheim Hospital in Belgium.

Dr. De Deyn and co-investigators at the University of California in San Diego, United States conducted their 10-week, multicentre, randomised trial to determine whether aripiprazole could reduce the psychotic symptoms seen in many elderly patients with Alzheimer's disease.

They enrolled 208 outpatients, who had a mean age of 81.5 years and baseline Mini-Mental State Examination and Neuropsychiatric Inventory scores of 14.2 and 6 or higher, respectively.

Patients received either aripiprazole or placebo. Initial dosage of aripiprazole was 2 mg/day, with flexible dosing ranging from 5 mg/day to 15 mg/day based on tolerance as assessed by investigators. The mean dose was 10 mg/day.

Completion rate was comparable for both groups -- at 83% with aripiprazole and 82% with placebo. Discontinuation because of adverse events was 8% in the treatment group and 7% in the placebo group.

Although little improvement in psychotic symptoms was seen from baseline to Week 6, patients began to improve more rapidly thereafter, De Deyn said, adding that the flexible dosing and slow up-titration helped researchers assess efficacy on an interim basis.

At week 10, aripiprazole and placebo showed comparable improvement in caregiver-rated Neuropsychiatric Inventory - Psychosis subscale change (-6.55 versus -5.52 at baseline respectively; p=0.17). However, Brief Psychiatric Rating Scale - Psychosis sub-scores improved substantially versus placebo (-1.93 vs. -1.27, p=0.03).

"The efficacy and tolerability parameters were very favourable, but the study size was a limitation," De Deyn said. He added, "The use of rescue medications such as lorazepam was a factor that needs to be looked at."


[Study title: Aripiprazole In Dementia Of The Alzheimer's Type, Abstract PO-87]

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