Study Stopped
A decision was made to discontinue the study due to a change in the strategic direction of the company.
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
Double-blind, Placebo-controlled Clinical Trial of JK6476 (Risperidone) in Patients With Hallucinations and Delusions Associated With Alzheimer's Disease
1 other identifier
interventional
33
0 countries
N/A
Brief Summary
The purpose of this study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo for the treatment of patients with hallucinations and delusions associated with Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2002
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedMay 24, 2011
November 1, 2010
February 3, 2006
May 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Alzheimer's disease according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
- Mini-Mental State Examination (MMSE) score of not greater than 23
- Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic score of \>=2 for any item in the psychotic cluster
- occurrence of hallucination or delusion after onset of symptoms of dementia at least 28 days before screening.
You may not qualify if:
- Patients with a disease that could significantly diminish cognitive function (e.g., Parkinsonism, Huntington's disease, Creutzfeldt-Jacob disease, dementia of Levy body type, vitamin B12 or folic acid deficiency)
- persistent dementia or amnestic disorders according to DSM-IV criteria
- occurrence of hallucination or delusion only while delirium is observed
- psychiatric symptoms induced by psychosis (e.g., schizophrenia, schizoaffective disorders, delusional disorders, depression or bipolar disorders)
- history of neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 7, 2006
Study Start
March 1, 2002
Study Completion
March 1, 2003
Last Updated
May 24, 2011
Record last verified: 2010-11