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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00305903 |
This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Rivastigmine, memantine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20) |
Estimated Enrollment: | 150 |
Study Start Date: | March 2006 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CENA713BUS32 |
Study First Received: | March 20, 2006 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00305903 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dementia, Alzheimer's, Rivastigmine, Memantine |
Excitatory Amino Acids Neurotransmitter Agents Rivastigmine Alzheimer Disease Central Nervous System Diseases Cholinergic Agents Brain Diseases Neurodegenerative Diseases Neuroprotective Agents |
Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Mental Disorders Memantine Dopamine Agents Dementia Delirium |
Neurotransmitter Agents Rivastigmine Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Excitatory Amino Acid Agents Neurodegenerative Diseases Brain Diseases Cholinergic Agents Neuroprotective Agents Mental Disorders Therapeutic Uses Memantine |
Dementia Excitatory Amino Acid Antagonists Nervous System Diseases Alzheimer Disease Central Nervous System Diseases Enzyme Inhibitors Protective Agents Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Agents Tauopathies Central Nervous System Agents |