Official Title: “Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: rivastigmine transdermal patch

Primary Measures

• Change in cognition from baseline at week 24
• Global clinical impression of change from baseline at week 24

Secondary 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00099242

Study ID Number: CENA713D2320

ClinicalTrials.gov Identifier: NCT00099242

Health Authority: United States: Food and Drug Administration

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