Source: DGNews  |  Posted 9 years ago

By Bruce Sylvester
Special to DG News

YOKOHAMA, JAPAN -- August 29, 2002 -- Low doses of risperidone are effective in treating behavioural and psychological symptoms of dementia (BPSD) in elderly nursing home subjects with dementia, researchers report.

This finding was presented at the 12th World Congress of Psychiatry being held in Yokohama, Japan.

Investigators, led by Peter Paul De Deyn, M.D, professor of neurology at the University of Antwerp in Belgium, performed a pooled analysis on three large 12-week, double-blind, placebo-controlled clinical trials involving 1150 subjects (risperidone N=722, placebo N=428). They studied the efficacy of risperidone with emphases on the treatment agitation, aggression and psychosis.

Inclusion criteria included institutionalization, mild dementia with >/= 4 on the Functional Assessment Staging (FAST) scale,

Mean age was 82.5 for risperidone subjects and 81.8 for placebo subjects. Mean age of dementia onset was 76.9 for risperidone subjects and 76.5 for placebo subjects. Mean age of onset of behavioural problems was 79.5 for risperidone subjects and 78.9 for placebo subjects.

The mean dosage of risperidone for 76.2 percent and the modal dose (most frequently used dose) for 70.1 percent was <1.5 mg/day.

"This data could be pooled because we same patients, the same duration of treatment and we used the same agent," said Dr. De Deyn.

To measure efficacy, the researchers used Cohen-Mansfield Agitation Inventory (CMAI) total and aggressive subscales, Behaviour Pathology of Alzheimer's Disease (BEHAVE-AD) total and the and psychotic symptom subscales, Clinical Global Impression of Change (CGI-C) and Clinical Global Impression of Change (CGI-S).

At endpoint, mean change in CMAI scores was significantly greater for risperidone versus placebo, for both total (-11.8 vs -6.4; p<0.001) and total aggression (-5.0 vs -1.8; p<0.001).

The mean change in BEHAVE-AD scores at endpoint was significantly greater for risperidone versus placebo, both for the total score (-6.1 and -3.6; p<0.001) and the psychotic symptoms subscore (-2.1 and -1.2; p=0.003).

There was no apparent difference in the CGI-S scores between risperidone and placebo subjects at baseline, however, from week two to endpoint caregivers rated significant improvement in risperidone subjects (endpoint: 1.1 for risperidone vs. 3.0 for placebo, p<0.001)

Mean CGI-S scores for risperidone and placebo subjects showed no apparent difference at baseline but researchers observed a statistically significant difference between the groups in overall CGI-C scores from week two to endpoint. Also at endpoint, the investigators rated 65.2 percent of the risperidone subjects and 45.2 percent of the placebo subjects as improved (p<0.001).

"This is actually the first data set with regard to atypical antipsychotic agents which show conclusively efficacy for control of BPSD," said Dr. De Deyn.

This study was sponsored by Johnson and Johnson Pharmaceutical Research and Development.