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

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID: NCT00428389
Run by: Novartis
People needed: 262
Starts: 2007-01-01
Expected to finish: 2008-02-01
Last updated by the study team: 2014-06-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Dedicated Clinical Research — Sun City, Arizona, United States
ATP Clinical Research — Costa Mesa, California, United States
Margolin Brain Institute — Fresno, California, United States
Investigative site — Denver, Colorado, United States
Berma Research Group — Hialeah, Florida, United States
Sunrise Clinical Research — Hollywood, Florida, United States
Center for Clinical Trials — Venice, Florida, United States
Premiere Research Institute @ Palm Beach Neurology — West Palm Beach, Florida, United States
Medical Associates of North Georgia — Canton, Georgia, United States
Medical Associates of North Georgia — Cumming, Georgia, United States
Witham Health Services — Lebanon, Indiana, United States
Investigative site — Pittsfield, Massachusetts, United States
Rochester Center For Behavioral Medicine — Rochester Hills, Michigan, United States
Alzheimer's Research Corporation — Manchester, New Hampshire, United States
Investigative site — Long Branch, New Jersey, United States
Neurobehavioral Research, Inc — Cedarhurst, New York, United States
Eastside Comprehensive Medical Center — New York, New York, United States
Investigative site — Centerville, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
Investigative site — Eugene, Oregon, United States
The Clinical Trial Center — Jenkintown, Pennsylvania, United States
Senior Adults Specialty Research — Austin, Texas, United States
Investigative site — Bennington, Vermont, United States

Full record on ClinicalTrials.gov

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