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

• Status: Completed
• Trial end date: 1996-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.