Rivastigmine Capsules in Patients With Probable Vascular Dementia
Phase 3
Completed
- Conditions
- Vascular Dementia
- Registration Number
- NCT00130338
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 521
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
- Secondary Outcome Measures
Name Time Method 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD