Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease

Official Title: “A 24-week, Multi-center, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)”

This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine 5 and 10 cm^2 patch

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Rivastigmine 5 and 10 cm^2 patch
  • For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.

Primary Measures

• Percentage of Patients Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study
  • Time Frame: Baseline to Week 24
    Safety Issue?: No
• Percentage of Patients Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study
  • Time Frame: Baseline to Week 24
    Safety Issue?: No
• Percentage of Patients Who Were Compliant to the 10 cm^2 Patch
  • Time Frame: Baseline to Week 24
    Safety Issue?: No

Secondary Measures

• Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24
  • Time Frame: Baseline and Week 24
    Safety Issue?: No
• Mean Change From Baseline in the Trail-making Test Part A Score at Week 24
  • Time Frame: Baseline to Week 24
    Safety Issue?: No
• Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24
  • Time Frame: Baseline to Week 24
    Safety Issue?: No
• Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
  • Time Frame: Baseline to Week 24
    Safety Issue?: No
• Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
  • Time Frame: Baseline t0 Week 24
    Safety Issue?: No
• Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24
  • Time Frame: Baseline to Week 24
    Safety Issue?: No

Inclusion Criteria:

• Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age
• Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria
• MMSE (Mini-Mental State Examination) score of > 10 and < 26
• Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)
• Patients who failed to benefit from previous cholinesterase inhibitor treatment

Exclusion Criteria:

• Patients not treated according to the product monograph for rivastigmine capsules
• patients involved in a clinical trial
• 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)
• Other protocol-defined exclusion criteria applied to the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00561392

Study ID Number: CENA713DDE15

ClinicalTrials.gov Identifier: NCT00561392

Health Authority: Germany: Federal Institute for Drugs and Medical Devices