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)

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 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine transdermal patch
  • The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.

Primary Measures

• Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Clinical Global Impression of Change (CGI-C) by Physician
  • Time Frame: Baseline and week 24
    Safety Issue?: No
• Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score
  • Time Frame: Baseline to week 24
    Safety Issue?: No
• Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score
  • Time Frame: Baseline to week 24
    Safety Issue?: No
• Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score
  • Time Frame: Baseline to week 24
    Safety Issue?: No

Inclusion Criteria:

• 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 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 Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharma S.A.S. Principal Investigator Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Study ID Number: CENA713DFR08

ClinicalTrials.gov Identifier: NCT00622713

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