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

Phase 3CompletedNCT00219232

Novartis868 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

868

Conditions

Alzheimer's Disease

Interventions

Rivastigmine Transdermal PatchDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

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 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

Data from ClinicalTrials.gov

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