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

Condition(s) targeted: Alzheimer's Disease

Intervention: Rivastigmine patch (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis

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.

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

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

Primary outcome:

• Adverse Events

Patient Disposition

12-lead ECG

Vital Signs

Secondary outcome:

Clinical Global Impression of Change (CGIC), at baseline and end of study

MMSE, at screening and end of study

Neuropsychiatric Inventory- 10 item (NPI-10), at baseline and end of study

Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Dedicated Clinical Research, Sun City, Arizona 85351, United States

ATP Clinical Research, Costa Mesa, California 92626, United States

Margolin Brain Institute, Fresno, California 93720, United States

Investigative site, Denver, Colorado 80209, United States

Center for Clinical Trials, Venice, Florida 34285, United States

Berma Research Group, Hialeah, Florida 33016, United States

Premiere Research Institute @ Palm Beach Neurology, West Palm Beach, Florida 33407, United States

Sunrise Clinical Research, Hollywood, Florida 33021, United States

Medical Associates of North Georgia, Cumming, Georgia 30040, United States

Medical Associates of North Georgia, Canton, Georgia 30114, United States

Witham Health Services, Lebanon, Indiana 46052, United States

Investigative site, Pittsfield, Massachusetts 01201, United States

Rochester Center For Behavioral Medicine, Rochester Hills, Michigan 48307, United States

Alzheimer's Research Corporation, Manchester, New Hampshire 08759, United States

Investigative site, Long Branch, New Jersey 07740, United States

Neurobehavioral Research, Inc, Cedarhurst, New York 11516, United States

Eastside Comprehensive Medical Center, New York, New York 10021, United States

Investigative site, Centerville, Ohio 45459, United States

The Ohio State University, Columbus, Ohio 43210, United States

Investigative site, Eugene, Oregon 97401, United States

The Clinical Trial Center, Jenkintown, Pennsylvania 19046, United States

Senior Adults Specialty Research, Austin, Texas 78757, United States

Investigative site, Bennington, Vermont 05201, United States

Starting date: January 2007
Ending date: August 2007
Last updated: December 17, 2007