Official Title: “Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia”

The goal of this research study is to evaluate 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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine

Primary Measures

• Change in cognition from baseline at week 24
• Global clinical impression of change from baseline at week 24

Secondary Measures

• Change in activities of daily living from baseline at week 24
• Change in behavioral symptoms from baseline at week 24
• Change in clinical staging from baseline at week 24

Inclusion Criteria:

• Between the ages of 50 and 85 years old
• Have contact with a responsible caregiver 3 or more days per week
• Be male or a female who is surgically sterilized or one year post menopausal

Exclusion Criteria:

• Current diagnosis of severe or unstable cardiovascular or other diseases
• Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease

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

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00099216

Study ID Number: CENA713BIA05

ClinicalTrials.gov Identifier: NCT00099216

Health Authority: United States: Food and Drug Administration

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