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

• Status: Completed
• Trial end date: 1997-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.