Official Title: “An Open-Label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia”

The goal of this research study is to evaluate, in the open-label extension phase, the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.

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

Primary Measures

• Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD

Secondary Measures

• 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD

Inclusion Criteria:

• Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate.

Exclusion Criteria:

• Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00130338

Study ID Number: CENA713BIA05E1

ClinicalTrials.gov Identifier: NCT00130338

Health Authority: United States: Food and Drug Administration