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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2006
Intervention(s) in this Clinical Trial
- Drug: Rivastigmine
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00130338
