Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216502
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-09-13
Brief Title:
A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimers Disease
Sponsor:
Janssen-Cilag SpA
Organization:
Janssen-Cilag SpA
Study Overview
Official Title:
Long Term Treatment With Galantamine In Dementia
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 this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimers disease
Detailed Description:
Dementia is a chronic progressive brain disease that may involve a number of symptoms including memory loss and changes in personality behavior judgment attention span language and thought The most common type of dementia is Alzheimers disease Over time patients with Alzheimers disease may lose ability to perform daily tasks related to personal care for example bathing dressing eating and may be unable to handle money or travel to familiar places Previous short-term studies have shown galantamine to be safe and effective in treating patients with Alzheimers disease however the long-term safety and effectiveness of galantamine have not been examined This multicenter randomized study will assess whether long-term treatment with galantamine will delay the onset of symptoms associated with Alzheimers disease and examine the safety and effectiveness of long-term treatment with galantamine Patients will receive 12 months of open-label treatment with galantamine followed by 24 months of double-blind treatment with galantamine or placebo Safety evaluations incidence of adverse events physical examinations 12 lead ECGs vital signs laboratory tests will be performed throughout the study Effectiveness will be determined using standard tests and rating scales to assess mental status functioning thinking behavior judgment and language Mini Mental Status Exam MMSE Alzheimers Disease Assessment Scale ADAS-cog Disability Assessment for Dementia DAD and Clinicians Interview Based Impression of Changes plus Family Input CIBIC-plus After the first 4 weeks assessments will be performed every 3 months during the open-label phase first 12 months and then every 6 months during the double-blind phase 13-36 months Patients whose symptoms worsen as defined by an increase of or to 4 points in their ADAS-cog score from the start of the double-blind phase will be withdrawn from the study The study hypothesis is that long-term treatment with galantamine will be effective in delaying the cognitive deterioration in patients with Alzheimers disease and that galantamine is well-tolerated with long term treatment Galantamine 4 milligrams twice daily by mouth for 4 weeks then 8 milligrams twice daily for 48 weeks Thereafter galantamine will be given as 8 milligrams twice daily for an additional 24 months
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