Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304629
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2006-03-17
Brief Title:
Long-term Safety and Efficacy of Galantamine in Alzheimers Disease
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Long Term Safety and Efficacy of Galantamine in Alzheimers Disease Extension INT-8
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 long-term safety and efficacy of galantamine 12 mg bid will be documented during a one year open-label treatment in subjects with Alzheimers Disease who completed the GAL-INT-8 trial up to 400 eligible patients Safety will be tracked by means of adverse event reports laboratory parameters and physical exam Long-term efficacy will be evaluated by means of a Alzheimers Disease Assessment ScaleADAS and activities of daily living scale Disability Assessment for Dementia ScaleDAD
Detailed Description:
This is a twelve-month open-label trial in which treatment with 12 mg bid galantamine will be evaluated Only subjects who took trial medication during the 24-month trial period of GAL-INT-8 will be eligible Safety will be assessed by periodic physical examination vital signs ECG and laboratory tests and reports of adverse events The ADAS-cognitive scale and DAD scale will be used to document long-term efficacy
Patients will be seen at 6 monthly intervals but the ADAS-cognitive scale and DAD scale will only be performed at end of trial The treatment will consist of tablets which will contain 12 mg of galantamine Duration of treatment equals 12 months Patients will receive 1 tablet twice daily preferably to be taken with food breakfast in the morning at approximately 8 AM and a snack or meal in the evening at approximately 6PM
Patients will be seen at 6 monthly intervals but the ADAS-cognitive scale and DAD scale will only be performed at end of trial The treatment will consist of tablets which will contain 12 mg of galantamine Duration of treatment equals 12 months Patients will receive 1 tablet twice daily preferably to be taken with food breakfast in the morning at approximately 8 AM and a snack or meal in the evening at approximately 6PM
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