Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

November 16, 2011 updated by: Novartis Pharmaceuticals
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

708

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
      • Linz, Austria
      • Wien, Austria
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Amiens, France
      • Bordeaux, France
      • Lille Cedex, France
      • Marseille, France
      • Montpellier Cedex, France
      • Toulouse, France
      • Tours Cedex, France
  • Germany
      • Bautzen, Germany
      • Berlin, Germany
      • Bochum, Germany
      • Chemnitz, Germany
      • Eisenhuttenstadt, Germany
      • Erlangen, Germany
      • Freiburg, Germany
      • Luedenscheid, Germany
      • Osnabrueck, Germany
  • Italy
      • Ancona, Italy
      • Brescia, Italy
      • Firenze, Italy
      • Perugia, Italy
      • Reggio Emilia, Italy
      • Roma, Italy
      • Vicenza, Italy
  • Russian Federation
      • Moscow, Russian Federation
      • Saint-Petersburg, Russian Federation
  • Spain
      • Barakaldo, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Pamplona, Spain
      • Saint Cugat del Valles, Spain
  • Switzerland
      • Basel, Switzerland
      • Lausanne, Switzerland
  • United Kingdom
      • Bristol, United Kingdom
      • Clydebank, United Kingdom
      • East Sussex, United Kingdom
      • Southampton, United Kingdom
      • St Annes, United Kingdom
    • Newcastle
      • Newcastle Upon Tyne, Newcastle, United Kingdom
    • Wiltshire
      • Swindon, Wiltshire, United Kingdom
  • United States
    • California
      • Irvine, California, United States, 92618
      • San Francisco, California, United States, 94109
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Miami Beach, Florida, United States, 33140
      • Port Charlotte, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Missouri
      • St. Louis, Missouri, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States, 10003
    • Oregon
      • Portland, Oregon, United States, 97223
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Greensburg, Pennsylvania, United States, 15601
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Texas
      • Austin, Texas, United States, 78756
      • Houston, Texas, United States, 77030
    • Vermont
      • Bennington, Vermont, United States, 05201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 9, 2004

First Posted (Estimate)

December 10, 2004

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713BIA05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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