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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00234637 |
This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.
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: | An Open-Label Study to Evaluate the Efficacy and Safety of Add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment |
Estimated Enrollment: | 200 |
Study Start Date: | November 2003 |
Study Completion Date: | June 2005 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CENA713BFR05 |
Study First Received: | October 5, 2005 |
Last Updated: | November 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00234637 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Alzheimer's disease, switch, rivastigmine, memantine |
Excitatory Amino Acids Rivastigmine Galantamine Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Memantine Dementia Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents Enzyme Inhibitors Excitatory Amino Acid Agents Cholinergic Agents |
Protective Agents Neuroprotective Agents Pharmacologic Actions Cholinesterase Inhibitors Therapeutic Uses Dopamine Agents Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |