The purpose of the study is to collect follow-up data on the vital status (living or deceased) of patients who were randomized and treated in 3 previous studies of galantamine (an Alzheimer's disease medication) for the treatment of mild cognitive impairment. These data were not recorded during the course of these studies...
Date First Received: February 24, 2006
Last Updated: March 19, 2008
Verified by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., March 2008
Clinical Trial Phase: Phase 3 | Start Date: June 2004
Overall Status: Completed
Estimated Enrollment: 2058
Brief Summary
Official Title: “A Retrospective Analysis of Mortality in Subjects Who Participated in 3 Studies of Galantamine in Mild Cognitive Impairment”
Condition Keyword(s):
The purpose of the study is to collect follow-up data on the vital status (living or deceased) of patients who were randomized and treated in 3 previous studies of galantamine (an Alzheimer's disease medication) for the treatment of mild cognitive impairment. These data were not recorded during the course of these studies.
Study Type: Observational
Study Design: Retrospective
Detailed Clinical Trial Description
The objective of this observational study is to ascertain follow-up vital status data for patients who were randomized and treated with galantamine or placebo in 3 previous trials (CR003145, CR002014, and CR005947). This study is designed to evaluate the imbalance of deaths that were initially recorded in the double-blind phases of two of these trials. Data will be combined from three sources: the databases of the 3 previous studies, forms from investigators, and data acquired during the present study. If a patient was found to have died, the investigator records the cause of death and the adverse events leading to death, by a review of medical records, autopsy records, and/or death certificates.
N/A
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Overall Clinical Trial Officials and Contacts
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00297414
Study ID Number: CR004240
ClinicalTrials.gov Identifier: NCT00297414
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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