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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00622713 |
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: Rivastigmine transdermal patch |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26) |
Estimated Enrollment: | 300 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Rivastigmine transdermal patch |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CENA713DFRO8, N° EudraCT : 2007-003405-27 |
Study First Received: | February 14, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00622713 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Alzheimer's disease cholinesterase inhibitor rivastigmine |
Neurotransmitter Agents Rivastigmine Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cholinergic Agents Neuroprotective Agents |
Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Arnold-Chiari Malformation Mental Disorders Dementia Delirium |
Neurotransmitter Agents Rivastigmine 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 |
Protective Agents Neuroprotective Agents Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Dementia Tauopathies Central Nervous System Agents |