Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease

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 was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included 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.

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