Official Title: “A Prospective, 5-Week, Open-Label, Randomized, Multi-Center, Parallel-Group Study With a 20-Week, Open-Label Extension Evaluating the Tolerability and Safety of Switching From Donepezil to an Initial Dose of 5 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease”

This study is designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study includes a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine patch
• Drug: rivastigmine transdermal patch

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Any reasons for discontinuation.
  • Time Frame: Throughout the study.
    Safety Issue?: Yes

Secondary Measures

• Clinical Global Impression of Change (CGIC)
  • Time Frame: At baseline, week 5 and end of study
    Safety Issue?: No
• Mini Mental State Exam (MMSE)
  • Time Frame: At screening and end of study
    Safety Issue?: No
• Neuropsychiatric Inventory- 10 item (NPI-10)
  • Time Frame: At baseline and end of study
    Safety Issue?: No
• Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
  • Time Frame: Baseline and week 25
    Safety Issue?: No

Inclusion Criteria:

• Be at least 50 years of age;
• Have a diagnosis of probable Alzheimer's Disease;
• Have an MMSE score of > or = 10 and < or = 24;
• Must have a caregiver who is able to attend all study visits;
• Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months.

Exclusion Criteria:

• Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
• Have a history of malignancy of any organ system, treated or untreated, within the past 5 years;
• Have a history within the past year or current diagnosis of cerebrovascular disease;
• Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months;
• Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease);
• Digestive problems related to peptic ulcer;
• Urinary obstruction or current severe urinary tract infection;
• Abnormal thyroid function tests;
• Low folate or Vitamin B12;
• Have a disability that may prevent the patient from completing all study requirements;
• Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch;
• 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

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/NCT00428389

Study ID Number: CENA713DUS38

ClinicalTrials.gov Identifier: NCT00428389

Health Authority: United States: Food and Drug Administration