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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00428389

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Rivastigmine patch Drug: rivastigmine transdermal patch	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: E 2020 Donepezil Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Any reasons for discontinuation. [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	262
Study Start Date:	January 2007
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Rivastigmine patch Drug: rivastigmine transdermal patch
2: Experimental	Drug: Rivastigmine patch Drug: rivastigmine transdermal patch

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428389

Show 23 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CENA713DUS38
Study First Received:	January 26, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00428389 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Dementia, Alzheimer's, Rivastigmine, donepezil

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Rivastigmine
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Donepezil
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010