Back to resultsRivastigmine Capsules in Patients With Probable Vascular Dementia
Primary Purpose
Vascular Dementia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rivastigmine
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia focused on measuring Dementia, Vascular, Rivastigmine, Stroke, Memory loss
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
Secondary Outcome Measures
52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00130338
Brief Title
Rivastigmine Capsules in Patients With Probable Vascular Dementia
Official Title
An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia
Keywords
Dementia, Vascular, Rivastigmine, Stroke, Memory loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
521 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rivastigmine
Primary Outcome Measure Information:
Title
Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
Secondary Outcome Measure Information:
Title
52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Rivastigmine Capsules in Patients With Probable Vascular Dementia
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