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Mild Cognitive ImpairmentNCT00297414

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

An observational study of Mild Cognitive Impairment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 144 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Mild Cognitive Impairment
How many people
1,083 participants
Where
144 sitesin 16 countries
Study dates
Jun 2004to Jan 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients not enrolled in above referenced studies

Trial locations and contacts

144 sites in 16 countries.

144 sites in 16 countries

United States50 sites

  • Study site

    Albany, New York

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bennington, Vermont

  • Study site

    Boston, Massachusetts

  • Study site

    Chicago, Illinois

  • Study site

    Clementon, New Jersey

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Durham, North Carolina

  • Study site

    East Providence, Rhode Island

  • Study site

    Farmington Hills, Michigan

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Glen Burnie, Maryland

  • Study site

    Hamden, Connecticut

  • Study site

    Hartford, Connecticut

  • Study site

    Houston, Texas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Laguna Woods, California

  • Study site

    Miami, Florida

  • Study site

    Middleton, Wisconsin

  • Study site

    New Haven, Connecticut

  • Study site

    New Hyde Park, New York

  • Study site

    New York, New York

  • Study site

    North Miami, Florida

  • Study site

    Northridge, California

  • Study site

    Oceanside, California

  • Study site

    Oscala F, Florida

  • Study site

    Paducah, Kentucky

  • Study site

    Paramount, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Pittsfield, Massachusetts

  • Study site

    Portland, Oregon

  • Study site

    Providence, Rhode Island

  • Study site

    Richmond, Virginia

  • Study site

    Ridgewood, New Jersey

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    St. Petersburg, Florida

  • Study site

    Staten Island, New York

  • Study site

    Summit, New Jersey

  • Study site

    Tacoma, Washington

  • Study site

    The Bronx, New York

  • Study site

    Toledo, Ohio

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita Falls, Texas

Other trials in United States

Canada21 sites

  • Study site

    Barrie, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    London, Ontario

  • Study site

    London

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal

  • Study site

    North York, Ontario

  • Study site

    North York

  • Study site

    Ottawa, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saint John, New Brunswick

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    T2n

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Verdun, Quebec

Other trials in Canada

Belgium10 sites

  • Study site

    Aalst

  • Study site

    Antwerp

  • Study site

    Hasselt

  • Study site

    Jumet

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Merksem

  • Study site

    Reet

  • Study site

    Roeselare

  • Study site

    Wilrijk

Other trials in Belgium

Australia8 sites

  • Study site

    Adelaide

  • Study site

    Christchurch Nz

  • Study site

    Hornsby Streets

  • Study site

    Kew

  • Study site

    Parkville

  • Study site

    Perth

  • Study site

    Randwick

  • Study site

    Woodville

Other trials in Australia

Czechia8 sites

  • Study site

    Chomutov

  • Study site

    Dobřany

  • Study site

    Hluboká nad Vltavou

  • Study site

    Kolín

  • Study site

    Opava

  • Study site

    Praha 8 N/A

  • Study site

    Rennes Cedex

  • Study site

    Ústí nad Labem

Other trials in Czechia

Poland7 sites

  • Study site

    Gdansk

  • Study site

    Katowice Poland

  • Study site

    Lodz

  • Study site

    Mosina Poland

  • Study site

    Poznan

  • Study site

    Poznan Poland

  • Study site

    Warsaw

Other trials in Poland

Sweden7 sites

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Mölndal

  • Study site

    Piteå

  • Study site

    Stockholm

  • Study site

    Umeå

Other trials in Sweden

Germany6 sites

  • Study site

    Berlin

  • Study site

    Frankfurt am Main

  • Study site

    Mannheim

  • Study site

    München

  • Study site

    Nuremberg

  • Study site

    Ulm

Other trials in Germany

United Kingdom6 sites

  • Study site

    Bradford

  • Study site

    Bristol

  • Study site

    Clydebank

  • Study site

    New Milton

  • Study site

    Southampton

  • Study site

    Swindon

Other trials in United Kingdom

Netherlands5 sites

  • Study site

    's-Hertogenbosch

  • Study site

    Alkmaar

  • Study site

    Amsterdam

  • Study site

    Breda

  • Study site

    Maastricht

Other trials in Netherlands

Israel4 sites

  • Study site

    Haifa

  • Study site

    Petach Tikya

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Spain4 sites

  • Study site

    Barakaldo Vizcaya S/N

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Terrasa Barcelona N/A

Other trials in Spain

Austria3 sites

  • Study site

    Graz

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

Argentina2 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

Other trials in Argentina

Finland2 sites

  • Study site

    Helsinki

  • Study site

    Kuopio

Other trials in Finland

France1 site

  • Study site

    Toulouse

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
No intervention
Keywords
Mild Cognitive Impairment, Dementia, Galantamine, Memory disorders, Isolated memory impairment, Alzheimer's disease
Medical subject headings
Cognitive Dysfunction, Dementia, Memory Disorders, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    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.

Study groups in NCT00297414
Study groupRoleWhat they receive
Patients with mild cognitive impairmentPatients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2006 (estimated)
  2. Study startJun 2004
  3. Primary completionJan 2005
  4. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
1,083 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297414
Sponsor's protocol ID
CR004240
Other IDs
GAL-COG-3002
Status last verified
Apr 2012
First submitted
24 Feb 2006
Last updated
12 Apr 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 144 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Canada, Belgium, Australia, Czechia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate vital status of patients enrolled in 3 galantamine studies (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00297414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.

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Clinical Trial NCT00297414 | AzTrials