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

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ClinicalTrials.gov Identifier: NCT00253123
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : December 3, 2010
Information provided by:
Janssen, LP

Brief 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.

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 cognitive function (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. The study is composed of a screening visit, followed by two study phases: a 1-week run-in period in which patients are discontinued from other antipsychotic drugs and receive placebo twice daily, and a 12-week double-blind period. At the end of the run-in period, patients are randomly assigned to one of three risperidone doses (0.5, 1, or 2 mg/day) or placebo. All patients randomized to risperidone start with 0.25 mg twice daily. During the first week of the double-blind period, patients assigned to the 1 mg/day dose group have their doses increased to 0.5 mg twice daily and patients assigned to the 2 mg/day dose group have their doses increased to 1 mg twice daily. These three assigned doses continue for an additional 11 weeks. The primary measure of effectiveness is the change from baseline in the clinical response, defined as a reduction of >= 30% from baseline on the total Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) score. Additional efficacy testing includes 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 that is completed by the patient's caregiver; the Physical Self-Maintenance Scale (PSMS), a scale that measures activities of daily living (for example, toileting, dressing, grooming, feeding, etc.). Safety evaluations include the incidence of adverse events; results of clinical laboratory tests (hematology, biochemistry, urinalysis); measurements of vital signs; physical examination and electrocardiogram (ECG) findings; 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 tablets (or placebo tablets) taken orally, starting with 0.25 mg twice daily, continuing at this dose for the 0.25 twice daily group and gradually increasing to either 0.5 mg twice daily or 1 mg twice daily in the other risperidone dose groups. Treatment duration is 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone for Treatment of Behavioral Disturbances in Subjects With Dementia
Actual Study Completion Date : March 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Risperidone

Primary Outcome Measures :
  1. Reduction of >= 30% from baseline to the end of double-blind treatment on the total BEHAVE-AD score.

Secondary Outcome Measures :
  1. Change from baseline to the end of double-blind treatment in BEHAVE-AD global rating and total score; total CMAI score; CGI and CGI change from baseline; PSMS; 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 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00253123

Sponsors and Collaborators
Janssen, LP
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Study Director: Janssen, LP Clinical Trial Janssen, LP
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00253123    
Other Study ID Numbers: CR006022
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010
Keywords provided by Janssen, LP:
Alzheimer's disease
vascular dementia
mixed dementia
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