Abstract
Objective: The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD). Method: The authors conducted a randomized, eight-week, double-blind, placebo-controlled, multicenter trial involving nursing home residents diagnosed with AD and psychosis. Four hundred seventy-three patients were randomly assigned to placebo (N = 238) or 1.0 to 1.5 mg risperidone per day (N = 235). Coprimary efficacy end points were: changes in scores on the Behavioral pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression of Change (CGI-C). Protocol-specified subgroup analyses were performed by demographics and dementia severity. Results: Efficacy analysis included 416 patients. Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups. In the subgroups analyses, a statistically significant treatment by Mini-Mental Status Examination (MMSE) interaction on the CGI-C (F[2,381] = 3.90, p = 0.021) was observed with patients with more severe dementia (MMSE <10) showing significant differences at end point favoring risperidone treatment (χ2 [1] = 5.11, p = 0.024). Mean risperidone dose was 1.03 ± 0.24 mg per day. All-cause discontinuation rates were 25% for both risperidone and placebo. Treatment-emergent adverse events occurred in 74% risperidone versus 64% placebo patients, with somnolence occurring significantly more frequently with risperidone (16.2% versus 4.6%). Nine (3.8%) risperidone- and six (2.5%) placebo patients died during or within 30 days after treatment. Conclusion: This trial did not confirm earlier findings in this population.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 280-291 |
| Number of pages | 12 |
| Journal | American Journal of Geriatric Psychiatry |
| Volume | 14 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 2006 |
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Keywords
- Alzheimer disease
- Psychosis
- Risperidone
ASJC Scopus subject areas
- Psychiatry and Mental health
- Geriatrics and Gerontology
Cite this
Risperidone in the treatment of psychosis of Alzheimer disease : Results from a prospective clinical trial. / Mintzer, Jacobo; Greenspan, Andrew; Caers, Ivo; Van Hove, Ilse; Kushner, Stuart; Weiner, Myron; Gharabawi, Georges; Schneider, Lon S.
In: American Journal of Geriatric Psychiatry, Vol. 14, No. 3, 03.2006, p. 280-291.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Risperidone in the treatment of psychosis of Alzheimer disease
T2 - Results from a prospective clinical trial
AU - Mintzer, Jacobo
AU - Greenspan, Andrew
AU - Caers, Ivo
AU - Van Hove, Ilse
AU - Kushner, Stuart
AU - Weiner, Myron
AU - Gharabawi, Georges
AU - Schneider, Lon S.
PY - 2006/3
Y1 - 2006/3
N2 - Objective: The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD). Method: The authors conducted a randomized, eight-week, double-blind, placebo-controlled, multicenter trial involving nursing home residents diagnosed with AD and psychosis. Four hundred seventy-three patients were randomly assigned to placebo (N = 238) or 1.0 to 1.5 mg risperidone per day (N = 235). Coprimary efficacy end points were: changes in scores on the Behavioral pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression of Change (CGI-C). Protocol-specified subgroup analyses were performed by demographics and dementia severity. Results: Efficacy analysis included 416 patients. Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups. In the subgroups analyses, a statistically significant treatment by Mini-Mental Status Examination (MMSE) interaction on the CGI-C (F[2,381] = 3.90, p = 0.021) was observed with patients with more severe dementia (MMSE <10) showing significant differences at end point favoring risperidone treatment (χ2 [1] = 5.11, p = 0.024). Mean risperidone dose was 1.03 ± 0.24 mg per day. All-cause discontinuation rates were 25% for both risperidone and placebo. Treatment-emergent adverse events occurred in 74% risperidone versus 64% placebo patients, with somnolence occurring significantly more frequently with risperidone (16.2% versus 4.6%). Nine (3.8%) risperidone- and six (2.5%) placebo patients died during or within 30 days after treatment. Conclusion: This trial did not confirm earlier findings in this population.
AB - Objective: The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD). Method: The authors conducted a randomized, eight-week, double-blind, placebo-controlled, multicenter trial involving nursing home residents diagnosed with AD and psychosis. Four hundred seventy-three patients were randomly assigned to placebo (N = 238) or 1.0 to 1.5 mg risperidone per day (N = 235). Coprimary efficacy end points were: changes in scores on the Behavioral pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression of Change (CGI-C). Protocol-specified subgroup analyses were performed by demographics and dementia severity. Results: Efficacy analysis included 416 patients. Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups. In the subgroups analyses, a statistically significant treatment by Mini-Mental Status Examination (MMSE) interaction on the CGI-C (F[2,381] = 3.90, p = 0.021) was observed with patients with more severe dementia (MMSE <10) showing significant differences at end point favoring risperidone treatment (χ2 [1] = 5.11, p = 0.024). Mean risperidone dose was 1.03 ± 0.24 mg per day. All-cause discontinuation rates were 25% for both risperidone and placebo. Treatment-emergent adverse events occurred in 74% risperidone versus 64% placebo patients, with somnolence occurring significantly more frequently with risperidone (16.2% versus 4.6%). Nine (3.8%) risperidone- and six (2.5%) placebo patients died during or within 30 days after treatment. Conclusion: This trial did not confirm earlier findings in this population.
KW - Alzheimer disease
KW - Psychosis
KW - Risperidone
UR - http://www.scopus.com/inward/record.url?scp=33644885707&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33644885707&partnerID=8YFLogxK
U2 - 10.1097/01.JGP.0000194643.63245.8c
DO - 10.1097/01.JGP.0000194643.63245.8c
M3 - Article
C2 - 16505133
AN - SCOPUS:33644885707
VL - 14
SP - 280
EP - 291
JO - American Journal of Geriatric Psychiatry
JF - American Journal of Geriatric Psychiatry
SN - 1064-7481
IS - 3
ER -