Status:
COMPLETED
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)
Lead Sponsor:
Novartis
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable Alzheimer...
Eligibility Criteria
Inclusion
- Males, and females of at least 50 years old with a primary caregiver
- Probable Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
- Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
- Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday
Exclusion
- Patients not treated according to the product monograph for capsules
- Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
- History of allergy to topical products containing any of the constituents of the patches
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00622713
Start Date
January 1 2008
End Date
January 1 2009
Last Update
July 26 2011
Active Locations (1)
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1
Novartis Investigative Site
Rueil-Malmaison, France