Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the safety and efficacy of risperidone (an antipsychotic medication) to that of 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 function in cognition (think...
Eligibility Criteria
Inclusion
- Patients with dementia of the Alzheimer's type, mixed dementia, or vascular dementia, (as classified by the Diagnostic and Statistical Manual of Mental Diseases, 4th edition \[DSM-IV\]) and have behavioral disturbances
- a score \>=4 on the FAST
- a score \<=23 on the MMSE
- a BEHAVE-AD total score \>=8, and a BEHAVE-AD global rating \>=1
- must be institutionalized.
Exclusion
- Patients with other medical or neurological conditions in which cognition (thinking, perception, learning, verbal communication, memory, judgment) is diminished (for example, drug overdosage, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
- other psychiatric disorders, including major depression, schizophrenia, substance abuse or dependence
- abnormal electrocardiogram (ECG) findings
- abnormal clinical laboratory test findings.
Key Trial Info
Start Date :
April 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1996
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00249145
Start Date
April 1 1995
End Date
December 1 1996
Last Update
January 14 2011
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