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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: November 2005
Intervention(s) in this Clinical Trial
- Drug: Rivastigmine
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00099216
