Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: rosiglitazone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, 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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
GSK Investigational Site, Litchfield Park, Arizona 85340, United States
GSK Investigational Site, Phoenix, Arizona 85006, United States
GSK Investigational Site, Sun City, Arizona 85351, United States
GSK Investigational Site, Belmont, Massachusetts 02478, United States
GSK Investigational Site, Ann Arbor, Michigan 48109, United States
GSK Investigational Site, Durham, North Carolina 27705, United States
GSK Investigational Site, Montreal, Quebec H4H 1R3, Canada
Additional Information
Related publications: This study has not been published in the scientific literature.
Starting date: June 2006
Last updated: November 21, 2013
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