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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT00299676
First received: March 3, 2006
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Dementia
Galantamine
Drug: Galantamine (Reminyl)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: May 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet
Drug: Galantamine (Reminyl)
Use of Reminyl according to approved NZ data sheet

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299676

Locations
Australia
Auckland, Australia
Christchurch Nz, Australia
Hamilton, Australia
Porirua, Australia
Tauranga, Australia
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00299676     History of Changes
Other Study ID Numbers: CR004816
Study First Received: March 3, 2006
Last Updated: May 22, 2014
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Alzheimer's Disease
Dementia
Post Marketing
Prospective Studies
Longitudinal Studies
New Zealand
Cholinesterase Inhibitors
Observational
Outcomes

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014