Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
Lead Sponsor:
Janssen-Cilag Pty Ltd
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the effectiveness of an oral formulation of risperidone (an antipsychotic medication) to that of placebo for treating behavioral and psychological signs and symp...
Detailed Description
Dementia is a term used for a collection of symptoms that can be caused by a number of diseases or injuries that affect the brain. Individuals with dementia have a loss of function in cognition (think...
Eligibility Criteria
Inclusion
- Dementia of the Alzheimer's type with behavioral disturbance, vascular dementia with behavioral disturbance, or mixed dementia, as classified by DSM-IV (the Diagnostic and Statistical Manual of Mental Diseases, 4th edition)
- a score \>=4 on the FAST (Functional Assessment Staging, a diagnosis tool for determining the stage of dementia) and a score \<=23 on the MMSE (Mini-Mental State Examination, a clinical measure used to evaluate cognition)
- a BEHAVE-AD (Behavior Pathology in Alzheimer's Disease Rating Scale) total score \>=8, and a BEHAVE-AD global rating \>=1
- patient must be living in an nursing home for \>=1 month.
Exclusion
- Patients with other medical or neurological conditions other than dementia in which cognition is diminished (for example, severe anemia, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
- diagnosis of depression within the 6 months before study entry, schizophrenia, bipolar affective disorder, or schizoaffective disorder
- history of or moderate to severe tardive dyskinesia, (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs)
- abnormal clinical laboratory test findings.
Key Trial Info
Start Date :
March 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2001
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00249158
Start Date
March 1 1998
End Date
February 1 2001
Last Update
November 19 2010
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