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

May 22, 2014 updated by: Janssen-Cilag Pty Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auckland, Australia
      • Christchurch Nz, Australia
      • Hamilton, Australia
      • Porirua, Australia
      • Tauranga, Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer's disease, who are currently not in permanent residential care. A convenience sampling method was applied.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet
Drug: Galantamine (Reminyl)
Use of Reminyl according to approved NZ data sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting.
Time Frame: Baseline, month 3, month 6, month 12 and month 18.
Baseline, month 3, month 6, month 12 and month 18.

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of information regarding treatment expectations that can be used for communicating with patients and supporters.
Time Frame: Baseline, month 3, month 6, month 12 and month 18.
Baseline, month 3, month 6, month 12 and month 18.
Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers.
Time Frame: Baseline, month 3, month 6, month 12 and month 18.
Baseline, month 3, month 6, month 12 and month 18.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (ESTIMATE)

March 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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