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 (MMSE10-26)”

This study will evaluate the safety and efficacy of 10 cm2 Rivastigmine Patch in patients with Alzheimer Disease (MMSE 10-26). Primary objective is the percentage of patients who stay on the target size of 10 cm2 for at least 8 weeks. This proportion will then be compared to historic data with the percentage of patients who could reach Rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks, in previous Rivastigmine trials.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks).
  • Time Frame: after 24 weeks
    Safety Issue?: No

Secondary Measures

• Cognitive and global outcome of the patients: Mini-Mental-State-Examination
  • Time Frame: Screening, after 4, 8 and 24 weeks
    Safety Issue?: No
• Clinical Global Impression of Change
  • Time Frame: after 4, 8 and 24 weeks
    Safety Issue?: No
• Trail Making Test A
  • Time Frame: Baseline, after 4, 8 and 24 weeks
    Safety Issue?: No
• Activities of Daily living
  • Time Frame: Baseline, after 4, 8 and 24 weeks
    Safety Issue?: No
• Safety/tolerability data (AEs and SAEs)
  • Time Frame: Throughout the trial
    Safety Issue?: Yes
• Patient compliance with the patch (drug accounting)
  • Time Frame: Throughout the study
    Safety Issue?: No
• Caregiver preference and satisfaction with the patch
  • Time Frame: Week 24
    Safety Issue?: No
• Caregiver burden (mini-Zarit score)
  • Time Frame: Baseline, after 4, 8 and 24 weeks
    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 DSMIV (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 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

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

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