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Trial record 1 of 1 for:    NCT00249145
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A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249145
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 14, 2011
Information provided by:
Janssen Pharmaceutica N.V., Belgium

Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Dementia, Vascular Drug: risperidone Phase 3

Detailed Description:
Dementia is a term used for a collection of symptoms that can be caused by a number of diseases or injuries that affect the brain. Individuals with dementia have a loss of function in cognition (thinking, perception, learning, verbal communication, memory, judgment), which may lead to behavioral and personality changes (for example, agitation, delusions, hallucinations). Some causes of dementia are reversible; however, irreversible dementia is caused by certain conditions, such as Alzheimer's disease. Dementia is common in elderly individuals, but it is not a normal part of aging. This is a randomized, double-blind, parallel-group, placebo-controlled study comparing the effectiveness and safety of risperidone to placebo in patients with behavioral disturbances associated with dementia. Haloperidol is included as a reference therapy to confirm that the efficacy analyses are valid. The study is composed of two periods: a 1-week run-in period in which patients are discontinued from other antipsychotic drugs and take placebo twice daily and a 12-week double-blind treatment period. At the end of the run-in period, patients are randomly assigned to one of three risperidone doses, or placebo, or haloperidol (all oral solutions). The starting dose of risperidone and haloperidol is 0.25 milligrams (mg) twice daily, which is increased gradually to a maximum dose of 2 mg/day. If the patient does not have a sufficient response, the dose can be gradually increased to a maximum of 4 mg/day. The patient receives these doses for the remainder of the double-blind period. The primary measure of effectiveness is a reduction of >= 30% from baseline to the end of double-blind treatment on the total Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) score. The BEHAVE-AD is a rating scale used to evaluate behavior symptoms in patients with Alzheimer's disease. Additional efficacy measures include the Clinical Global Impressions (CGI), a rating system used to evaluate the overall and severity of clinical change in a patient with various diseases affecting the brain; the Cohen-Mansfield Agitation Inventory (CMAI), a questionnaire evaluating agitation; the Functional Assessment Staging (FAST), a diagnostic tool for determining the stage of dementia; and the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition. Safety evaluations include the incidence of adverse events; results of clinical laboratory tests (hematology, biochemistry, urinalysis); measurements of vital signs; physical and neurological examinations and electrocardiogram (ECG) findings; evaluations of the presence and severity of sedation; a computed tomography (CT) scan of the brain; and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor functions of the patient. The study hypothesis is that risperidone is more effective than placebo, as measured by a change from baseline on the total BEHAVE-AD score, in treating behavioral disturbances in demented patients. Risperidone oral solution 1 mg/mL; haloperidol oral solution, 1 mg/mL; placebo oral solution. Starting doses of 0.25 mg twice daily and increasing to 2 mg/day. If 2 mg/day shows an insufficient response, a maximum of 4 mg/day of risperidone or haloperidol is permitted. Total treatment duration is 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Behavioral Disturbances in Demented Patients: an International, Multicenter, Placebo-controlled, Double-blind, Parallel-group Trial Using Haloperidol as Internal Reference
Study Start Date : April 1995
Actual Study Completion Date : December 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Risperidone

Primary Outcome Measures :
  1. Change from baseline to end of double-blind treatment on the total BEHAVE-AD score.

Secondary Outcome Measures :
  1. Change from baseline to end of double-blind treatment in global rating, total BEHAVE-AD score, total CMAI score, CGI severity, FAST, and MMSE; safety evaluations conducted throughout the study

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249145

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
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Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
Publications of Results:
Layout table for additonal information Identifier: NCT00249145    
Other Study ID Numbers: CR006046
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: January 2011
Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Alzheimer's Disease
vascular dementia
mixed dementia, risperidone
nursing home
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia, Vascular
Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs