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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00304629 |
The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8 trial (up to 400 eligible patients). Safety will be tracked by means of adverse event reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale Disability Assessment for Dementia Scale(DAD)
Condition | Intervention | Phase |
---|---|---|
Alzheimer Disease |
Drug: galantamine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long Term Safety and Efficacy of Galantamine in Alzheimer's Disease (Extension INT-8) |
Estimated Enrollment: | 258 |
Study Start Date: | March 2000 |
Estimated Study Completion Date: | March 2002 |
This is a twelve-month, open-label trial in which treatment with 12 mg bid galantamine will be evaluated. Only subjects who took trial medication during the 24-month trial period of GAL-INT-8 will be eligible. Safety will be assessed by periodic physical examination, vital signs, ECG and laboratory tests and reports of adverse events. The ADAS-cognitive scale and DAD scale will be used to document long-term efficacy. Patients will be seen at 6 monthly intervals but the ADAS-cognitive scale and DAD scale will only be performed at end of trial.
The treatment will consist of tablets which will contain 12 mg of galantamine. Duration of treatment equals 12 months. Patients will receive 1 tablet twice daily preferably to be taken with food (breakfast in the morning at approximately 8 AM and a snack or meal in the evening at approximately 6PM).
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR012070 |
Study First Received: | March 17, 2006 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00304629 |
Health Authority: | United States: Institutional Review Board |
cholinesterase inhibitors galantamine Alzheimer's disease |
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 |