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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine Transdermal Patch

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

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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Corporation Study Director Novartis  

Information obtained from ClinicalTrials.gov on September 04, 2008

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