An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine
An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment
2 other identifiers
observational
1,083
15 countries
141
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2004
Shorter than P25 for all trials
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedApril 12, 2012
April 1, 2012
7 months
February 24, 2006
April 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate vital status of patients enrolled in 3 galantamine studies
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
Study Arms (1)
Patients with mild cognitive impairment
Patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.
Interventions
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.
Eligibility Criteria
Study population included patients randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)
You may qualify if:
- All patients who were randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)
You may not qualify if:
- Patients not enrolled in above referenced studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (144)
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Tucson, Arizona, United States
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Laguna Woods, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Paramount, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Hamden, Connecticut, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Oscala F, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Paducah, Kentucky, United States
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Glen Burnie, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Kalamazoo, Michigan, United States
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Clementon, New Jersey, United States
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Ridgewood, New Jersey, United States
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Summit, New Jersey, United States
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Albany, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Wichita Falls, Texas, United States
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Bennington, Vermont, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Middleton, Wisconsin, United States
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Buenos Aires, Argentina
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Córdoba, Argentina
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Adelaide, Australia
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Christchurch Nz, Australia
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Hornsby Streets, Australia
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Kew, Australia
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Parkville, Australia
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Perth, Australia
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Randwick, Australia
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Woodville, Australia
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Graz, Austria
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Innsbruck, Austria
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Vienna, Austria
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Aalst, Belgium
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Antwerp, Belgium
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Hasselt, Belgium
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Jumet, Belgium
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Leuven, Belgium
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Liège, Belgium
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Merksem, Belgium
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Reet, Belgium
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Roeselare, Belgium
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Wilrijk, Belgium
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Verdun, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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London, Canada
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Montreal, Canada
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North York, Canada
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T2n, Canada
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Chomutov, Czechia
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Dobřany, Czechia
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Hluboká nad Vltavou, Czechia
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Kolín, Czechia
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Opava, Czechia
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Praha 8 N/A, Czechia
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Rennes Cedex, Czechia
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Ústí nad Labem, Czechia
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Helsinki, Finland
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Kuopio, Finland
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Toulouse, France
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Berlin, Germany
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Frankfurt am Main, Germany
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Mannheim, Germany
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München, Germany
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Nuremberg, Germany
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Ulm, Germany
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Haifa, Israel
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Petach Tikya, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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's-Hertogenbosch, Netherlands
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Breda, Netherlands
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Maastricht, Netherlands
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Gdansk, Poland
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Katowice Poland, Poland
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Lodz, Poland
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Mosina Poland, Poland
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Poznan, Poland
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Poznan Poland, Poland
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Warsaw, Poland
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Barakaldo Vizcaya S/N, Spain
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Barcelona, Spain
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Madrid, Spain
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Terrasa Barcelona N/A, Spain
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Linköping, Sweden
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Lund, Sweden
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Malmo, Sweden
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Mölndal, Sweden
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Piteå, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Bradford, United Kingdom
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Bristol, United Kingdom
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Clydebank, United Kingdom
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New Milton, United Kingdom
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Southampton, United Kingdom
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Swindon, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
June 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
April 12, 2012
Record last verified: 2012-04