A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Behavioral Disturbances in Patients With Dementia
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|ClinicalTrials.gov Identifier: NCT00253123|
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : December 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease Dementia, Vascular||Drug: risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||626 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone for Treatment of Behavioral Disturbances in Subjects With Dementia|
|Actual Study Completion Date :||March 1997|
U.S. FDA Resources
- Reduction of >= 30% from baseline to the end of double-blind treatment on the total BEHAVE-AD score.
- Change from baseline to the end of double-blind treatment in BEHAVE-AD global rating and total score; total CMAI score; CGI and CGI change from baseline; PSMS; safety evaluations conducted throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253123
|Study Director:||Janssen, LP Clinical Trial||Janssen, LP|