An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Novartis0 sites868 target enrollmentFebruary 2003

ConditionsAlzheimer's Disease

DrugsRivastigmine Transdermal Patch

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Novartis
Enrollment: 868
Primary Endpoint: Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

July 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

Secondary Outcomes

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
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