Status:
COMPLETED
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to investigate the 5cm\^2 and 10cm\^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE \[Mini M...
Detailed Description
Patients were randomly assigned in a double-blind manner to one of the 3 treatment arms (placebo, rivastigmine 5 cm\^2 and rivastigmine 10 cm\^2) in a ratio of 1:1:1. During the Double-blind treatment...
Eligibility Criteria
Inclusion
- A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
- A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
- An MMSE score of \> or = 10 and \< or = 20
Exclusion
- A current DSM-IV diagnosis of major depression
- Taken rivastigmine in the past
- A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined inclusion/exclusion criteria may apply
- Other protocol-defined inclusion/exclusion criteria may apply
- Extension Phase Eligibility Criteria
- Inclusion Criteria:
- Patients who have completed the Double-blind Treatment Phase on study medication
- Exclusion Criteria
- Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
859 Patients enrolled
Trial Details
Trial ID
NCT00423085
Start Date
January 1 2007
End Date
April 1 2010
Last Update
February 10 2014
Active Locations (1)
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1
Novartis Investigative Site
Hokkaido Region, Hokkaido, Japan