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Sponsored by: |
Janssen Pharmaceutical K.K. |
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Information provided by: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT00301574 |
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease, and to investigate the dose-response.
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: galantamine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Placebo-Controlled, Double-Blind Study of Galantamine (R113675) in the Treatment of Alzheimer's Disease. |
Estimated Enrollment: | 390 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | February 2004 |
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day [mg/day]) in patients with Alzheimer's disease, and to investigate the dose-response. The study consists of a 4-week screening period during which all patients will receive placebo, and a 22-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 22) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be more effective in the treatment of Alzheimer's disease than placebo.
Study drug taken orally twice a day. 4-week screening period: All patients receive placebo. 22-week treatment period: Patients receive placebo, galantamine 16 mg/day, or 24 mg/day. For galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003301 |
Study First Received: | March 10, 2006 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00301574 History of Changes |
Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Alzheimer's disease Cognitive dysfunction |
Nootropic Agents Neurotransmitter Agents Galantamine Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cholinergic Agents |
Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Peripheral Nervous System Agents Dementia Delirium |
Parasympathomimetics Nootropic Agents Neurotransmitter Agents Galantamine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Brain Diseases |
Neurodegenerative Diseases Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents Mental Disorders Therapeutic Uses Peripheral Nervous System Agents Dementia Tauopathies Central Nervous System Agents |