A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia

• Status: Completed
• Trial end date: 2001-02-01
• Target enrollment: 0
• Participant gender: All

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 symptoms in dementia (BPSSD), specifically aggression, delusions, and hallucinations, in patients with dementia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Pty Ltd
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.