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Rivastigmine Capsules in Patients With Probable Vascular Dementia

Primary Purpose

Vascular Dementia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rivastigmine
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Dementia focused on measuring Dementia, Vascular, Rivastigmine, Stroke, Memory loss

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 11, 2005
    Last Updated
    March 24, 2017
    Sponsor
    Novartis
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    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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