Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261573
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-12-02
Brief Title:
A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Safety and Efficacy of Galantamine in the Treatment of Vascular and Mixed Dementia
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 this study is to evaluate the safety and efficacy of galantamine a drug for treating dementia compared to placebo in the treatment of patients with dementia related to cerebrovascular disease vascular dementia or dementia related to Alzheimers disease with cerebrovascular disease mixed dementia
Detailed Description:
This multicenter double-blind placebo-controlled study will evaluate the safety and effectiveness of galantamine in patients with dementia related to cerebrovascular disease or related to Alzheimers disease with cerebrovascular disease mixed dementia All patients will initially receive placebo for a 1-month period and then will receive galantamine starting at a low dose and gradually increasing over 5 weeks to 12 mg twice daily or placebo for 6 months The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog11 score Alzheimers Disease Assessment Scale sum of 11 cognitive items and the CIBIC-plus score Clinicians Interview Based Impression of Change - Plus Caregiver Input Additional measures of effectiveness include the change from baseline to the end of the treatment in the ADAS-cog13 score Alzheimers Disease Assessment Scale sum of 13 cognitive items the Disability Assessment for Dementia DAD score and the Neuropsychiatric Inventory NPI score Safety evaluations incidence of adverse events electrocardiograms ECGs physical examinations laboratory tests will be performed throughout the study Patients who complete the double-blind portion of the study will have the opportunity to participate in a 6-month open-label extension study in which they will receive galantamine for an additional 6 months Effectiveness will be assessed after 6 weeks 3 months and 6 months of open-label treatment Safety evaluations incidence of adverse events ECGs physical examinations laboratory tests will be performed throughout the open-label portion of the study The study hypothesis is that galantamine will be effective in the treatment of patients with vascular or mixed dementia and will be well tolerated Double-blind Galantamine 12 mg or placebo by mouth twice daily for 6 months starting at a low dose and gradually increasing over 5 weeks to the final dose Open-label galantamine 12 mg by mouth twice daily starting at a low dose and gradually increasing over 6 weeks to the final dose
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