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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299676
• Other study ID #: CR004816
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2006
• Last updated: May 22, 2014
• Start date: May 2005
• Est. completion date: March 2008

Study information

• Verified date: May 2014
• Source: Janssen-Cilag Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Galantamine

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting.		Baseline, month 3, month 6, month 12 and month 18.	No
Secondary	Development of information regarding treatment expectations that can be used for communicating with patients and supporters.		Baseline, month 3, month 6, month 12 and month 18.	No
Secondary	Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers.		Baseline, month 3, month 6, month 12 and month 18.	No