Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Behavioral Disturbances in Patients With Dementia
Lead Sponsor:
Janssen, LP
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of risperidone (an antipsychotic medication) versus placebo in the treatment of behavioral disturbances associated with dementia.
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 cognitive function (thinking...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of dementia of the Alzheimer's type, mixed dementia, or vascular dementia, as classified by the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- a score of 4 or more on the Functional Assessment Staging (FAST), a diagnostic tool for determining the stage of dementia
- a score of 23 or lower on the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition
- a BEHAVE-AD total score of at least 8, and a BEHAVE-AD global rating of at least 1
- residence in a psychiatric hospital, nursing home, or other long-term care facility for at least 1 month.
Exclusion
- Patients with untreated, reversible causes of dementia
- with general medical or neurological conditions in which cognition is diminished (for example, untreated vitamin deficiency, severe liver or kidney malfunctions, brain tumor, etc.)
- with dementia related to HIV infection (human immunodeficiency virus)
- with a substance-induced persisting dementia
- with psychiatric disorders that could account for the behavior disturbances, such as schizophrenia.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1997
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT00253123
End Date
March 1 1997
Last Update
December 3 2010
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