This study will evaluate the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable Alzheimer's...
Date First Received: September 17, 2007
Last Updated: June 6, 2008
Verified by: Novartis, June 2008
Clinical Trial Phase: Phase 3 | Start Date: August 2007
Overall Status: Enrolling by invitation
Estimated Enrollment: 500
Brief Summary
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)”
Condition Keyword(s):
Intervention(s):
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
Intervention(s) in this Clinical Trial
- Drug: rivastigmine transdermal patch
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- Safety & tolerability throughout the 52 weeks of treatment assessed by: • Adverse Events • Vital signs • ECGs • Laboratory tests • Skin Irritation
Secondary Measures
- • Change from baseline in the MMSE (Mini mental state examination) after 52 weeks of treatment • Change from baseline in the DAD (Disability Assessment for Dementia) after 52 weeks of treatment • Change from baseline in the Modified Crichton Scale
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Principal Investigator +81 3 3797 8748
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
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