Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299676
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2006-03-03
Brief Title:
An Observational Study of the Safety and Effectiveness of Galantamine in the Treatment of Patients With Alzheimers Disease Over an 18-month Period
Sponsor:
Janssen-Cilag Pty Ltd
Organization:
Janssen-Cilag Pty Ltd
Study Overview
Official Title:
An Observational Study of Clinical Outcomes and Safety Profile of Galantamine in the Treatment of Patients With Alzheimers Disease Over an 18-month Period
Status:
COMPLETED
Status Verified Date:
2014-05
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 observational study is to investigate the changes in cognitive functioning behavior and functional improvement in Alzheimers disease patients treated with Galantamine who are living at home ie not in permanent residential care and to obtain information regarding usual clinical practice that can be used for communicating treatment expectations to patients and supporters
Detailed Description:
This is a prospective observational study to assess the changes in cognitive functioning behavior and functional improvement in Alzheimers disease patients treated with Galantamine who are living at home ie not in permanent residential care and to obtain information regarding usual clinical practice performed by relevant specialists There will be no experimental component associated with this study and all observational activities will be part of routine care This study will follow patients with Alzheimers disease who are currently not in permanent residential care for a period of 18 months The three domains of cognition behavior and function will be evaluated at baseline using the Mini-Mental State Examination MMSE andor ADAS-Cog the abridged Instrumental Activities of Daily Living IADL and a 14-item behavioral assessment scale Changes in the 3 domains will be observed after 3 6 12 and 18 months of Galantamine therapy through the completion of The Clinician Interview Based Impression of Change CIBIC-Plus abridged IADL behavioral changes and the Mini-Mental State ExaminationADAS-Cog Primary outcome is to determine changes from baseline in cognition behavior and function will be assessed after 3 6 12 and 18 months as measured by the CIBIC-Plus abridged IADL the Mini-Mental State ExaminationADAS-Cog and behavioral changes The secondary outcome is development of information regarding treatment expectations that can be used for communicating with patients and supporters Galantamine will be prescribed according to routine clinical practice and as per the Product Information leaflet
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