Clinical trial NCT00428389: Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Dementia, Alzheimer's, Rivastigmine, donepezil
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 262
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study
timeFrame: Baseline through the end of the core phase of the study (Week 5)
Secondary outcomes:
measure: Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study
timeFrame: Baseline through the end of study (25 weeks)
measure: Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase
timeFrame: From week 5 through the end of extension phase (25 weeks)
measure: Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25
timeFrame: Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)
measure: Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study
timeFrame: Baseline and Week 25 (end of the extension phase) and at the end of study
measure: Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.
timeFrame: Baseline, Week 25 (end of the extension phase) and at End of Study
measure: Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study
timeFrame: Baseline, Week 25 (end of the extension phase) and at the end of Study
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Denver
country: United States
facility: Investigative site
state: Colorado
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research
state: Florida
city: Venice
country: United States
facility: Center for Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute @ Palm Beach Neurology
state: Florida
city: Canton
country: United States
facility: Medical Associates of North Georgia
state: Georgia
city: Cumming
country: United States
facility: Medical Associates of North Georgia
state: Georgia
city: Lebanon
country: United States
facility: Witham Health Services
state: Indiana
city: Pittsfield
country: United States
facility: Investigative site
state: Massachusetts
city: Rochester Hills
country: United States
facility: Rochester Center For Behavioral Medicine
state: Michigan
city: Manchester
country: United States
facility: Alzheimer's Research Corporation
state: New Hampshire
city: Long Branch
country: United States
facility: Investigative site
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: Centerville
country: United States
facility: Investigative site
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Eugene
country: United States
facility: Investigative site
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Bennington
country: United States
facility: Investigative site
state: Vermont
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Farlow MR, Alva G, Meng X, Olin JT. A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer's disease: a post hoc analysis. Curr Med Res Opin. 2010 Feb;26(2):263-9. doi: 10.1185/03007990903434914.