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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00561392 |
This study will evaluate the safety and efficacy of 10 cm2 Rivastigmine Patch in patients with Alzheimer Disease (MMSE 10-26). Primary objective is the percentage of patients who stay on the target size of 10 cm2 for at least 8 weeks. This proportion will then be compared to historic data with the percentage of patients who could reach Rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks, in previous Rivastigmine trials.
Condition | Intervention | Phase |
Alzheimer's Disease |
Drug: Rivastigmine |
Phase IV |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Disease |
ChemIDplus related topics: | Rivastigmine SDZ-ENA 713 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
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 (MMSE10-26) |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
1: Experimental | Drug: Rivastigmine |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Contact: Novartis | +41 61 324 1111 |
Germany | |||||
Novartis Investigative Site | Recruiting | ||||
Munich, Germany | |||||
Contact +41 61 324 1111 |
Novartis |
Principal Investigator: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CENA713DDE15 |
First Received: | November 19, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00561392 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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