Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034762
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2002-05-02
Brief Title:
Efficacy and Safety of Risperidone Compared With Placebo in the Treatment of Psychotic Symptoms in Patients With Alzheimers Disease
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Efficacy And Safety Of A Flexible Dose Of Risperidone Versus Placebo In The Treatment Of Psychosis Of Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of risperidone compared with placebo in the treatment of psychotic symptoms in patients with Alzheimers disease
Detailed Description:
Dementia is frequently observed in the elderly often associated with psychotic symptoms such as delusion or hallucinations or with behavioral disturbances such as aggressive behavior wandering and aimless behavior induced by the psychotic symptoms This is a double-blind placebo-controlled study of the effectiveness and safety of risperidone taken twice daily over 8 weeks in the treatment of psychotic symptoms in patients with Alzheimers disease Assessments of effectiveness include Behavioral Pathology in Alzheimers Disease BEHAVE-AD a scale used for global assessment of symptoms associated with dementia the Psychosis Cluster Scale of BEHAVE-AD a subscale that assesses paranoid and delusional ideation as well as hallucination and Clinical Global Impression-Change CGI-C a measure of an improved or aggravated condition Safety evaluations include the incidence of adverse events throughout the study physical examinations electrocardiograms ECGs laboratory tests hematology biochemistry urinalysis and assessment of extrapyramidal symptoms at specified intervals The study hypothesis is that treatment with risperidone shows greater improvement in psychotic symptoms as measured by the BEHAVE-AD psychotic cluster score in patients with Alzheimers disease as compared to placebo In addition it is hypothesized that risperidone is well tolerated Risperidone tablets 025 mg or 050 mg or placebo tablets taken orally twice daily Total daily dosage of 05mg on Day 1 10mg on Days 3-5 and 15mg maximum dose on Days 5-13 Optimum dose maintained during Weeks 3-8 of treatmentDose may be increased or decreased at investigators discretion
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