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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: rivastigmine transdermal patch
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00099242
