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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: December 10, 2004
Last updated: December 17, 2007
Last verified: December 2007
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:

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

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00099242

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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

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

ClinicalTrials.gov processed this record on May 26, 2016