Clinical trial NCT00297414: An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine
Official title: An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Dementia
Galantamine
Memory disorders
Isolated memory impairment
Alzheimer's disease
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 1083
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate vital status of patients enrolled in 3 galantamine studies
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
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state: Arizona
city: Laguna Woods
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state: California
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state: California
city: Paramount
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state: California
city: San Diego
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state: California
city: San Francisco
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state: California
city: Hamden
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state: Connecticut
city: Hartford
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state: Connecticut
city: New Haven
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city: Fort Lauderdale
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state: Florida
city: Miami
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state: Florida
city: North Miami
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city: Saint Petersburg
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city: St. Petersburg
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city: Atlanta
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state: Georgia
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state: Illinois
city: Paducah
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state: Kentucky
city: Glen Burnie
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state: Maryland
city: Rockville
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state: Maryland
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state: Massachusetts
city: Pittsfield
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state: Massachusetts
city: Farmington Hills
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state: Michigan
city: Kalamazoo
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state: Michigan
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state: Vermont
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state: Virginia
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state: Washington
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state: Wisconsin
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
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country: Australia
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city: Hornsby Streets
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city: Innsbruck
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city: Wien
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city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Hasselt
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country: Belgium
city: Liege
country: Belgium
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country: Belgium
city: Reet
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city: Edmonton
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state: Alberta
city: Vancouver
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city: Moncton
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city: Saint John
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city: Halifax
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city: Pointe-Claire
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state: Quebec
city: Quebec City
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state: Quebec
city: Verdun
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city: Saskatoon
country: Canada
state: Saskatchewan
city: London N/A
country: Canada
city: Montreal N/A
country: Canada
city: North York
country: Canada
city: T2n
country: Canada
city: Chomutov N/A
country: Czech Republic
city: Dobrany N/A
country: Czech Republic
city: Hluboká Nad Vltavou
country: Czech Republic
city: Kolín 2
country: Czech Republic
city: Opava
country: Czech Republic
city: Praha 8 N/A
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city: Rennes Cedex
country: Czech Republic
city: Usti Nad Labem N/A
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city: Helsinki
country: Finland
city: Kuopio N/A
country: Finland
city: Toulouse
country: France
city: Berlin
country: Germany
city: Frankfurt Am Main
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Nürnberg
country: Germany
city: Ulm
country: Germany
city: Haifa
country: Israel
city: Petach Tikya
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: 'S-Hertogenbosch
country: Netherlands
city: Alkmaar
country: Netherlands
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Maastricht
country: Netherlands
city: Gdansk
country: Poland
city: Katowice Poland
country: Poland
city: Lodz N/A
country: Poland
city: Mosina Poland
country: Poland
city: Poznan N/A
country: Poland
city: Poznan Poland
country: Poland
city: Warszawa
country: Poland
city: Barakaldo Vizcaya S/N
country: Spain
city: Barcelona N/A
country: Spain
city: Madrid
country: Spain
city: Terrasa Barcelona N/A
country: Spain
city: Linköping
country: Sweden
city: Lund N/A
country: Sweden
city: Malmö
country: Sweden
city: Mölndal N/A
country: Sweden
city: Piteå
country: Sweden
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Bradford
country: United Kingdom
city: Bristol
country: United Kingdom
city: Clydebank
country: United Kingdom
city: New Milton
country: United Kingdom
city: Southampton
country: United Kingdom
city: Swindon
country: United Kingdom
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial
role: STUDY_DIRECTOR
References: