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Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099242
First received: December 10, 2004
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.


Condition Intervention Phase
Alzheimer's Disease
Dementia, Alzheimer Type
 Drug: rivastigmine transdermal patch
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in cognition from baseline at week 24
  • Global clinical impression of change from baseline at week 24

Secondary Outcome Measures:
  • Change from baseline at week 24 in activities of daily living
  • Change from baseline at week 24 in behavioral symptoms
  • Change from baseline at week 24 in global cognitive testing
  • Change from baseline at week 24 in executive function
  • Change from baseline at week 24 in attention

Estimated Enrollment: 1040
Study Start Date: November 2003
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of dementia of the Alzheimer's type
  • Males, and females who are surgically sterile or one year postmenopausal
  • A primary caregiver willing to accept responsibility for supervising the treatment

Exclusion Criteria:

  • Any condition (other than Alzheimer's) that could explain patient's dementia
  • An advanced, severe or unstable disease that may put the patient at special risk
  • Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099242

  Show 75 Study Locations
Sponsors and Collaborators
Novartis
  More Information

Additional Information:
Click here for further information and to find an investigational site near you  This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00099242     History of Changes
Other Study ID Numbers: CENA713D2320
Study First Received: December 10, 2004
Last Updated: December 17, 2007
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 May 16, 2013