A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Patients With Hallucinations and Delusions Associated With Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00287742|
Recruitment Status : Terminated (A decision was made to discontinue the study due to a change in the strategic direction of the company.)
First Posted : February 7, 2006
Last Update Posted : May 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Dementia||Drug: risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Double-blind, Placebo-controlled Clinical Trial of JK6476 (Risperidone) in Patients With Hallucinations and Delusions Associated With Alzheimer's Disease|
|Study Start Date :||March 2002|
|Actual Study Completion Date :||March 2003|
U.S. FDA Resources
- Change in Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic symptom cluster score from baseline and intermediate visits to study end (Week 9) compared with placebo.
- Changes in BEHAVE-AD total, subscales and items scores, changes in CMAI aggressiveness and non-aggressiveness item scores and changes in CGI-C from baseline and intermediate visits to study end (Week 9) compared with placebo. Safety evaluations.
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): NCT00287742
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|