Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287742
Status:
TERMINATED
Last Update Posted:
2011-05-24
First Post:
2006-02-03
Brief Title:
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Patients With Hallucinations and Delusions Associated With Alzheimers Disease
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
Double-blind Placebo-controlled Clinical Trial of JK6476 Risperidone in Patients With Hallucinations and Delusions Associated With Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A decision was made to discontinue the study due to a change in the strategic direction of the company
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effectiveness and safety of risperidone an antipsychotic medication versus placebo for the treatment of patients with hallucinations and delusions associated with Alzheimers disease
Detailed Description:
Dementia is frequently observed in the elderly often associated with psychotic symptoms such as delusion or hallucination or with behavioral disturbances such as aggressive behavior wandering and aimless behavior induced by the psychotic symptoms Based on the results of preliminary clinical studies risperidone can be expected to be beneficial for the treatment of psychotic symptoms and behavioral disturbances associated with Alzheimers disease This is a multicenter randomized double-blind placebo-controlled study of risperidone tablets or placebo tablets taken twice daily over 9 weeks by patients with hallucinations and delusions associated with Alzheimers disease During the one week run-in period patients take one tablet twice daily During the 8 week double-blind period the dose is given twice daily in a flexible dose regimen of 05 to 2 mg of risperidone per day or placebo The primary measure of effectiveness is the change in Behavioral Pathology in Alzheimers Disease BEHAVE-AD psychotic symptom cluster score from baseline and intermediate visits to study end Week 9 compared with placebo BEHAVE-AD is a scale used for global assessment of symptoms associated with dementia Additional assessments of effectiveness include the Cohen-Mansfield Agitation Inventory CMAI an assessment of aggressiveness and non-aggressiveness and the Clinical Global Impression - Change CGI-C a measure of an improved or aggravated condition Safety evaluations include the incidence of adverse events physical examinations electrocardiograms ECGs laboratory tests biochemistry hematology and urinalysis and assessment of extrapyramidal symptoms The study hypothesis is that treatment twice daily with risperidone is more effective than placebo on measures of the BEHAVE-AD psychotic symptom cluster score in patients with hallucinations and delusions associated with Alzheimers disease Oral risperidone tablets 025 mg or placebo tablets twice daily increasing in weekly increments of 05 mgday to a maximum of 2 mgday total daily dosage will be maintained for 9 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