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Sponsored by: |
Janssen Cilag Pharmaceutica S.A.C.I., Greece |
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Information provided by: | Janssen Cilag Pharmaceutica S.A.C.I., Greece |
ClinicalTrials.gov Identifier: | NCT00297362 |
The purpose of this study is to evaluate the safety and effectiveness of galantamine hydrobromide (REMINYL®) in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide (REMINYL®).
Condition | Intervention | Phase |
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Brain Diseases Alzheimer Disease Mental Disorders Nervous System Diseases Dementia |
Drug: galantamine hydrobromide |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Open Observational Study Of Galantamine Hydrobromide (REMINYL®) Administration For The Treatment Of Patients With Mild To Moderate Dementia Of The Alzheimer Type |
Estimated Enrollment: | 320 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | October 2005 |
Galantamine hydrobromide (REMINYL®) is a medication that is approved for the treatment of symptoms of Alzheimer's disease. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label observational study to collect information regarding the safety and effectiveness of galantamine in patients with Alzheimer's disease. Patients who have been prescribed galantamine hydrobromide (REMINYL®) as initial treatment with this type of medication for their Alzheimer's disease or who have failed previous treatment with similar medication of this type for their Alzheimer's disease will receive galantamine for 6 months. The individual physicians responsible for the treatment of Alzheimer's disease will administer galantamine at doses appropriate for each patient and will continue to oversee their care. No medication will be supplied by the sponsor of this study. Safety evaluations (incidence of adverse events, physical exams, vital signs and laboratory tests) will be performed throughout the study. Effectiveness will be determined using standard tests and rating scales to assess mental status, functioning, thinking, behavior, judgment and language (Neuropsychiatric Inventory, [NPI], Mini Mental Status Exam [MMSE] and Clinical Global Impression-Caregiver [CGI-Caregiver]). Assessments will be conducted monthly for the first 3 months and at the end of 6 months of treatment. Galantamine treatment should be discontinued if there is no further indication of effectiveness. At the end of the study, the treating physician may continue treatment with galantamine in responding patients as appropriate. The study hypothesis is that galantamine will be effective in treating the symptoms associated with Alzheimer's disease and is safe and well-tolerated.
For patients who are new to exposure to an AChE (acetylcholinesterase) inhibitor, Reminyl will be administered according to the following schedule: Week 1 - 4: 4mg galantamine twice daily; Week 5 - 8: 8mg galantamine twice daily; Week 9 - 12: 12mg galantamine twice daily. Study duration: 6 Months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003559 |
Study First Received: | February 24, 2006 |
Last Updated: | October 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00297362 |
Health Authority: | Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines |
Memory Loss Dementia Alzheimer Disease |
Caregiver Galantamine hydrobromide Brain Disease |
Delirium, Dementia, Amnestic, Cognitive Disorders Galantamine Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Amnesia 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 |