Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Phase 3
Completed
- Conditions
- Vascular Dementia
- Registration Number
- NCT00099216
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 708
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in cognition from baseline at week 24 Global clinical impression of change from baseline at week 24
- Secondary Outcome Measures
Name Time Method 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