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Sponsored by: |
Janssen-Cilag Pty Ltd |
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Information provided by: | Janssen-Cilag Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00299676 |
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 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 |
Estimated Enrollment: | 60 |
Study Start Date: | April 2005 |
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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Alzheimer's Disease Cholinesterase Inhibitors Post Marketing New Zealand Dementia |
Longitudinal Studies outcomes Prospective Studies observational |
Delirium, Dementia, Amnestic, Cognitive Disorders Galantamine Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
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 |