Efficacy and Safety of Risperidone Compared With Placebo in the Treatment of Psychotic Symptoms in Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of risperidone compared with placebo in the treatment of psychotic symptoms in patients with Alzheimer's disease

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• A diagnosis of dementia of the Alzheimer's type with or without a vascular component, a score of 2 or more on any item of the BEHAVE-AD psychosis subscale at screening, and a Mini-Mental State Examination (MMSE) score of 5 to 23

• Residents of nursing homes or long-term care facilities and deemed in need of treatment with an atypical antipsychotic medication.

Exclusion Criteria:

• Disease that could significantly diminish cognitive function

• history of neuroleptic malignant syndrome

• hypersensitivity to risperidone.