NCT00299676

An Observational Study of the Safety and Effectiveness of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period

An Observational Study of Clinical Outcomes and Safety Profile of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Janssen-Cilag Pty Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this observational study is to investigate the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. 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 Alzheimer's disease patients treated with Galantamine who are living at home (i.e. 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 Alzheimer's 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) and/or 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 Examination/ADAS-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 Examination/ADAS-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

Conditions

• Alzheimer Disease
• Dementia
• Galantamine

Interventions

Type	Name	Description
DRUG	Galantamine (Reminyl)	Use of Reminyl according to approved NZ data sheet

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-03-07
• Last updated: 2014-05-23

Locations

5 sites across 1 country: Australia