NCT00297414

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

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,083

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Shorter than P25 for all trials

Geographic Reach
15 countries

141 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

February 24, 2006

Last Update Submit

April 11, 2012

Conditions

Keywords

Mild Cognitive ImpairmentDementiaGalantamineMemory disordersIsolated memory impairmentAlzheimer's disease

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.

Other: No intervention

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.

Patients with mild cognitive impairment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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Related Links

MeSH Terms

Conditions

Cognitive DysfunctionDementiaMemory DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTauopathiesNeurodegenerative Diseases

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial

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

    STUDY DIRECTOR

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

Locations