Official Title: “An Open-Label, 52-Week Extension to a 24-Week, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Evaluation of the Efficacy, Safety, and Tolerability of the Once-Daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-20)”

This study will evaluate the safety and tolerability of long-term treatment by 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

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Drug: rivastigmine transdermal patch

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Safety & tolerability assessed by: • Adverse Events • Vital signs • ECGs • Laboratory tests • Skin Irritation
  • Time Frame: throughout the 52 weeks of treatment
    Safety Issue?: Yes

Secondary Measures

• • Change from baseline in the MMSE (Mini mental state examination)
  • Time Frame: after 52 weeks of treatment
    Safety Issue?: No
• • Change from baseline in the DAD (Disability Assessment for Dementia)
  • Time Frame: after 52 weeks of treatment
    Safety Issue?: No
• • Change from baseline in the Modified Crichton Scale
  • Time Frame: after 52 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Patient who have completed the Double-blind Treatment Phase on study medication

Exclusion Criteria:

• Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase
• Other protocol-defined inclusion/exclusion criteria may apply

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

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator +81 3 3797 8748  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00531609

Study ID Number: CENA713D1301E1

ClinicalTrials.gov Identifier: NCT00531609

Health Authority: Japan: Ministry of Health, Labor and Welfare