An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine

April 11, 2012 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment

The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this observational study is to ascertain follow-up vital status data for patients who were randomized (assignment of study medication by chance) and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014 and CR005947). This study is designed to evaluate the imbalance of deaths that were initially recorded in the double-blind (neither physician nor patient knows the treatment that the patient receives) phases of two of these studies. Data will be combined from three sources: the databases of the 3 previous studies, forms from investigators, and data acquired during the present study. Investigator will obtain consent from the patients or their informant for participating in the study. Data on vital status will be obtained either from the patient or informant after obtaining informed consent. If a patient does not provide informed consent, documentation of contact with the patient will suffice as evidence that the patient is alive. If an informant does not provide informed consent or a patient cannot be contacted, medical or death records or death registers will be consulted when necessary to determine if a death occurred. If a patient was found to have died, the investigator records the cause of death, date of death, and the adverse events (unwanted consequence that occurs during the course of the clinical study, but not necessarily because of study medication) leading to death, by a review of medical records, autopsy records, and/or death certificates.

Study Type

Observational

Enrollment (Actual)

1083

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

  • Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
  • Australia
      • Adelaide, Australia
      • Christchurch Nz, Australia
      • Hornsby Streets, Australia
      • Kew, Australia
      • Parkville, Australia
      • Perth, Australia
      • Randwick, Australia
      • Woodville, Australia
  • Austria
      • Graz N/A, Austria
      • Innsbruck, Austria
      • Wien, Austria
  • Belgium
      • Aalst, Belgium
      • Antwerpen, Belgium
      • Hasselt, Belgium
      • Jumet, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Merksem, Belgium
      • Reet, Belgium
      • Roeselare, Belgium
      • Wilrijk, Belgium
  • Canada
      • London N/A, Canada
      • Montreal N/A, Canada
      • North York, Canada
      • T2n, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
      • Saint John, New Brunswick, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • North York, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
      • Quebec City, Quebec, Canada
      • Verdun, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Czech Republic
      • Chomutov N/A, Czech Republic
      • Dobrany N/A, Czech Republic
      • Hluboká Nad Vltavou, Czech Republic
      • Kolín 2, Czech Republic
      • Opava, Czech Republic
      • Praha 8 N/A, Czech Republic
      • Rennes Cedex, Czech Republic
      • Usti Nad Labem N/A, Czech Republic
  • Finland
      • Helsinki, Finland
      • Kuopio N/A, Finland
  • France
      • Toulouse, France
  • Germany
      • Berlin, Germany
      • Frankfurt Am Main, Germany
      • Mannheim, Germany
      • München, Germany
      • Nürnberg, Germany
      • Ulm, Germany
  • Israel
      • Haifa, Israel
      • Petach Tikya, Israel
      • Ramat Gan, Israel
      • Tel Aviv, Israel
  • Netherlands
      • 'S-Hertogenbosch, Netherlands
      • Alkmaar, Netherlands
      • Amsterdam, Netherlands
      • Breda, Netherlands
      • Maastricht, Netherlands
  • Poland
      • Gdansk, Poland
      • Katowice Poland, Poland
      • Lodz N/A, Poland
      • Mosina Poland, Poland
      • Poznan N/A, Poland
      • Poznan Poland, Poland
      • Warszawa, Poland
  • Spain
      • Barakaldo Vizcaya S/N, Spain
      • Barcelona N/A, Spain
      • Madrid, Spain
      • Terrasa Barcelona N/A, Spain
  • Sweden
      • Linköping, Sweden
      • Lund N/A, Sweden
      • Malmö, Sweden
      • Mölndal N/A, Sweden
      • Piteå, Sweden
      • Stockholm, Sweden
      • Umeå, Sweden
  • United Kingdom
      • Bradford, United Kingdom
      • Bristol, United Kingdom
      • Clydebank, United Kingdom
      • New Milton, United Kingdom
      • Southampton, United Kingdom
      • Swindon, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Laguna Woods, California, United States
      • Northridge, California, United States
      • Oceanside, California, United States
      • Paramount, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Connecticut
      • Hamden, Connecticut, United States
      • Hartford, Connecticut, United States
      • New Haven, Connecticut, United States
    • Florida
      • Fort Lauderdale, Florida, United States
      • Miami, Florida, United States
      • North Miami, Florida, United States
      • Oscala F, Florida, United States
      • Saint Petersburg, Florida, United States
      • St. Petersburg, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Paducah, Kentucky, United States
    • Maryland
      • Glen Burnie, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Pittsfield, Massachusetts, United States
    • Michigan
      • Farmington Hills, Michigan, United States
      • Kalamazoo, Michigan, United States
    • New Jersey
      • Clementon, New Jersey, United States
      • Ridgewood, New Jersey, United States
      • Summit, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Bronx, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Staten Island, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • E Providence, Rhode Island, United States
      • Providence, Rhode Island, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Wichita Falls, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Tacoma, Washington, United States
    • Wisconsin
      • Middleton, Wisconsin, United States

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population included patients randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)

Description

Inclusion Criteria:

  • All patients who were randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)

Exclusion Criteria:

  • Patients not enrolled in above referenced studies

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with mild cognitive impairment
Patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.
Other: No intervention
No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate vital status of patients enrolled in 3 galantamine studies
Time Frame: 4 weeks
Poststudy vital status (living or deceased) of patients who participated in 3 clinical studies with galantamine will be evaluated. Data will be collected as vital status of the patient, date of death, cause of death and adverse events associated with death.
4 weeks

Collaborators and Investigators

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

  • Study Director: Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

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

June 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 11, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004240
  • GAL-COG-3002 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC)

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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