Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249158
Status:
COMPLETED
Last Update Posted:
2010-11-19
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-Cilag Pty Ltd
Organization:
Janssen-Cilag Pty Ltd
Study Overview
Official Title:
Risperidone in the Treatment of Behavioural and Psychological Signs and Symptoms in Dementia BPSSD a Multicentre Double-blind Placebo-controlled Parallel-group Trial
Status:
COMPLETED
Status Verified Date:
2010-11
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 effectiveness of an oral formulation of risperidone an antipsychotic medication to that of placebo for treating behavioral and psychological signs and symptoms in dementia BPSSD specifically aggression delusions and hallucinations in patients 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 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 period At the end of the run-in period patients are randomly assigned to oral solutions of either risperidone or placebo The starting dose of risperidone is 025 mg twice daily and increasing to 05 mg twice daily 1 mgday If 1 mgday shows an insufficient response a maximum of 1 mg twice daily of risperidone is permitted The patient receives study drugs for the 12-week double-blind period The primary measure of effectiveness is the change from baseline to the end of double-blind treatment in the Cohen-Mansfield Agitation Inventory CMAI a questionnaire evaluating agitation Additional measures of efficacy include the change from baseline to end of double-blind treatment in the Behavior Pathology in Alzheimers Disease Rating Scale BEHAVE-AD a rating scale used to evaluate behavior symptoms in patients with Alzheimers disease 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 Functional Assessment Staging FAST a diagnosis 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 and biochemistry measurements of vital signs and body weight physical examination 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 the total aggression score on the CMAI in treating behavioral disturbances in demented patients Risperidone oral solution 1 mgmL Starting doses of 025 mg twice daily and increasing to 05 mg twice daily 1 mgday If 1 mgday shows an insufficient response a maximum of 1 mg twice daily of risperidone 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