Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: rosiglitazone maleate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This is an open-label extension to study 49653/461, to assess the long-term safety of
rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's
Disease.
Clinical Details
Official title: An Open-Label Extension to Study 49653/461, to Assess the Long-Term Safety of Rosiglitazone (Extended Release Tablets) in Subjects With Mild to Moderate Alzheimer's Disease
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Long term safety and tolerability of rosiglitazone (RSG) XR.
Secondary outcome: Long-term efficacy of RSG XR in terms of orientation, memory (recent and immediate), concentration, language and praxis.Frequency of serious adverse events. Percentage of subjects with adverse event of edema Change from baseline in vital signs. Frequency of vital signs of clinical concern. Change from baseline in weight. Frequency of clinical chemistry (including lipids) and hematology parameters of clinical concern.
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Male or female subject who has successfully completed the 12 Month Visit of 49653/461
(12 months of treatment) without tolerability issues, where in the opinion of the
subject and of the investigator, it will be beneficial to continue treatment with RSG
XR.
- Female subjects must be post-menopausal (i. e. >6 months without menstrual period),
surgically sterile, or if of child-bearing potential, using effective contraceptive
measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD) a
diaphragm with spermicide or a condom with spermicide). Women of childbearing
potential must use effective contraceptive measures throughout the study and for 30
days after discontinuing study medication. The subject and their caregiver must
ensure that the subject will continuously use contraceptive measures throughout the
duration of the study.
- Subject is willing to participate in the extension study and has provided full written
informed consent prior to the performance of any protocol-specified procedure; or if
unable to provide informed consent due to cognitive status, full written informed
consent on behalf of the subject has been provided by a legally acceptable
representative[1].[1] Where this is in accordance with local laws, regulations and
ethics committee policy.
- Caregiver has provided full written informed consent on his or her own behalf prior to
the performance of any protocol-specified procedure.
Exclusion criteria:
- Subject had a serious adverse experience (SAE) or clinically significant laboratory
abnormality during 49653/461, which in the opinion of the investigator could have been
attributable to study medication, and which is ongoing at the end of 49653/461.
- The subject is felt by the investigator to be unsuitable (on the basis of health,
compliance, caregiver availability, or for any other reason) for inclusion in the
study based on the entry criteria for the primary study, 49653/461 (exclusive of the
age criteria which may not be applicable to some of the subjects).
- The subject experienced a significant cardiovascular event during 49653/461
(e. g. intervention, percutaneous coronary intervention, vascular surgery, acute
coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction,
unstable angina] or significant arrhythmia), unless a thorough cardiovascular
evaluation has been performed which confirms that the subject does not have congestive
heart failure, and is clinically stable.
- Treatment with a cholinesterase inhibitor, selegiline, memantine or any other
treatment for cognitive symptoms/AD is initiated at the end of 49653/461.
Locations and Contacts
Dedicated Clinical Research, Sun City, Arizona 85351, United States; Recruiting
Maninder Kahlon, Phone: 623-972-3800
GSK Clinical Trials Call Center, Phoenix, Arizona 85006, United States; Recruiting
Barry Hendin, Phone: 877-379-3718
GSK Clinical Trials Call Center, Scottsdale, Arizona 85259, United States; Terminated
GSK Clinical Trials Call Center, Sun City, Arizona 85351, United States; Recruiting
Marwan Sabbagh, Phone: 877-379-3718
University of Arizona, Tucson, Arizona 85724, United States; Recruiting
Geoffrey Ahern, Phone: 520-626-4296, Email: gahern@u.arizona,.edu
GSK Clinical Trials Call Center, Belmont, Massachusetts 02478, United States; Recruiting
James Ellison, Phone: 877-379-3718
GSK Clinical Trials Call Center, Ann Arbor, Michigan 48109, United States; Recruiting
Nancy Barbas, Phone: 877-379-3718
GSK Clinical Trials Call Center, Durham, North Carolina 27705, United States; Recruiting
James Burke, Phone: 877-379-3718
Additional Information
Starting date: February 2006
Ending date: July 2009
Last updated: June 10, 2008
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