Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249145
Status:
COMPLETED
Last Update Posted:
2011-01-14
First Post:
2005-11-04
Brief Title:
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 025 milligrams mg twice daily which is increased gradually to a maximum dose of 2 mgday If the patient does not have a sufficient response the dose can be gradually increased to a maximum of 4 mgday 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 Alzheimers Disease Rating Scale BEHAVE-AD score The BEHAVE-AD is a rating scale used to evaluate behavior symptoms in patients with Alzheimers 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 mgmL haloperidol oral solution 1 mgmL placebo oral solution Starting doses of 025 mg twice daily and increasing to 2 mgday If 2 mgday shows an insufficient response a maximum of 4 mgday of risperidone or haloperidol is permitted Total treatment duration is 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None