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

NCT ID: NCT00299676

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

001

Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet

Galantamine (Reminyl)

Intervention Type: DRUG

Use of Reminyl according to approved NZ data sheet

Interventions

Galantamine (Reminyl)

Use of Reminyl according to approved NZ data sheet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients prescribed with galantamine according to the approved New Zealand Data Sheet
• The clinical decision to prescribe Galantamine must have been made before and independently of the decision to enroll the patient in this observational study
• The patient should not have commenced Galantamine treatment before the baseline visit
• Patients must be currently living at home (i.e. not in permanent residential care)
• Availability of a supporter who has regular contact with the patient

Exclusion Criteria

• Patients having known hypersensitivity to Galantamine
• Having severe liver impairment or severe kidney impairment
• Suffering from an uncontrolled medical condition other than dementia
• Being treated, or previously treated, with another cholinesterase inhibitor or other cholinomimetics (medications for treating Alzheimer's disease)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Pty Ltd Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Pty Ltd

Locations

Auckland, , Australia

Christchurch Nz, , Australia

Hamilton, , Australia

Porirua, , Australia

Tauranga, , Australia

Countries

Australia

Other Identifiers

CR004816

Identifier Type: -

Identifier Source: org_study_id