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Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
This study has been completed.
First Received: January 26, 2007   Last Updated: December 17, 2008   History of Changes
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:


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 Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

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