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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 is ongoing, but not recruiting participants.
Sponsored by: Janssen-Cilag Pty Ltd
Information provided by: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00299676
  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 Phase
Dementia
Alzheimer Disease
Galantamine
Phase IV

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia
Drug Information available for: Galantamine hydrobromide Galantamine
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
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

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

Estimated Enrollment: 60
Study Start Date: April 2005
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, behaviurbehavior, 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, behaviour, 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299676

Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

Study ID Numbers: CR004816
Study First Received: March 3, 2006
Last Updated: December 22, 2006
ClinicalTrials.gov Identifier: NCT00299676  
Health Authority: Australia: Department of Health

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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Galantamine
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009