A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Patients With Hallucinations and Delusions Associated With Alzheimer's Disease

• Status: Terminated
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo for the treatment of patients with hallucinations and delusions associated with Alzheimer's disease.

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of Alzheimer's disease according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)

• Mini-Mental State Examination (MMSE) score of not greater than 23

• Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic score of >=2 for any item in the psychotic cluster

• occurrence of hallucination or delusion after onset of symptoms of dementia at least 28 days before screening.

Exclusion Criteria:

• Patients with a disease that could significantly diminish cognitive function (e.g., Parkinsonism, Huntington's disease, Creutzfeldt-Jacob disease, dementia of Levy body type, vitamin B12 or folic acid deficiency)

• persistent dementia or amnestic disorders according to DSM-IV criteria

• occurrence of hallucination or delusion only while delirium is observed

• psychiatric symptoms induced by psychosis (e.g., schizophrenia, schizoaffective disorders, delusional disorders, depression or bipolar disorders)

• history of neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)