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)”

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

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine transdermal patch

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Percentage of patients treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population)

Secondary Measures

• Mini-Mental State Examination score at baseline, week 8, 24 and premature discontinuation
• Clinical Global Impression of Change (week 8, 24 and premature discontinuation)
• 4 scores from the Activities of Daily Living (budget, transport, drug management, phone) at baseline, week 8 and week 24 or at premature discontinuation
• At any time : Adverse events, vital signs, physical examination

Inclusion Criteria:

• Males, and females of at least 50 years old with a primary caregiver
• Probable Alzheimer's disease
• Mini-Mental State Examination score of ≥ 10 and ≤ 26
• Patients initiating therapy for the first time with a 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 Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma S.A.S. Principal Investigator Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00622713

Study ID Number: CENA713DFRO8

ClinicalTrials.gov Identifier: NCT00622713

Health Authority: France: Afssaps - French Health Products Safety Agency