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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219232
First received: September 14, 2005
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Rivastigmine Transdermal Patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Enrollment: 868
Study Start Date: February 2003
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219232

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219232     History of Changes
Other Study ID Numbers: CENA713D2320E1
Study First Received: September 14, 2005
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014