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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00297414
First received: February 24, 2006
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Other: No intervention
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • To evaluate vital status of patients enrolled in 3 galantamine studies [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1083
Study Start Date: June 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: No intervention

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297414

  Show 145 Study Locations
Sponsors and Collaborators
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.
  More Information

Additional Information:
No publications provided

Responsible Party: SENIOR DIRECTOR, CLINICAL LEADER, Janssen R&D US
ClinicalTrials.gov Identifier: NCT00297414     History of Changes
Other Study ID Numbers: CR004240, GAL-COG-3002
Study First Received: February 24, 2006
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Mild Cognitive Impairment
Dementia
Galantamine
Memory disorders
Isolated memory impairment
Alzheimer's disease

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014