search
Back to results

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

Primary Purpose

Dementia, Alzheimer Disease, Dementia, Vascular

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
risperidone
Sponsored by
Janssen Pharmaceutica N.V., Belgium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Alzheimer's Disease, vascular dementia, mixed dementia, risperidone, nursing home

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change from baseline to end of double-blind treatment on the total BEHAVE-AD score.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 4, 2005
    Last Updated
    January 13, 2011
    Sponsor
    Janssen Pharmaceutica N.V., Belgium
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00249145
    Brief Title
    A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1996 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutica N.V., Belgium

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Alzheimer Disease, Dementia, Vascular
    Keywords
    Dementia, Alzheimer's Disease, vascular dementia, mixed dementia, risperidone, nursing home

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    349 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    risperidone
    Primary Outcome Measure Information:
    Title
    Change from baseline to end of double-blind treatment on the total BEHAVE-AD score.
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutica N.V. Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutica N.V.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10496251
    Citation
    De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PL, Eriksson S, Lawlor BA. A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology. 1999 Sep 22;53(5):946-55. doi: 10.1212/wnl.53.5.946.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs