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An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00219232
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Rivastigmine Transdermal Patch Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 868 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Study Start Date : February 2003
Primary Completion Date : July 2006
Study Completion Date : July 2006





Primary Outcome Measures :
  1. Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

Secondary Outcome Measures :
  1. Change in cognition from baseline (week 24 of the double blind phase) at week 52
  2. Clinical global impression of change from baseline at week 52
  3. Change in activities of daily living from baseline at week 52
  4. Change in behavioral symptoms from baseline at week 52
  5. Change in executive function from baseline at week 52


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219232


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219232     History of Changes
Other Study ID Numbers: CENA713D2320E1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Alzheimer's disease
Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents