An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
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...
Brief Summary
Official Title: “An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease”
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
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2006
Intervention(s) in this Clinical Trial
- Drug: Rivastigmine Transdermal Patch
Outcome Measures for this Clinical Trial
Primary Measures
- Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment
Secondary 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
Criteria for Participation in this Clinical Trial
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.
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
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Corporation Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219232
Study ID Number: CENA713D2320E1
ClinicalTrials.gov Identifier: NCT00219232
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00219232
