Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

Stopped early · Phase 3

Conditions studied: Alzheimer's Disease

In brief

This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.

Key facts

Study ID

NCT00490568

Run by

GlaxoSmithKline

People needed

1461

Starts

2007-08-08

Expected to finish

2009-06-01

Last updated by the study team

2017-11-13

Who can join

Age: 51 and older, up to 91. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.

You may not qualify if…

• Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation. SAE, clinically significant laboratory abnormality or significant cardiovascular event during prior study.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Sherman Oaks, California, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Norwalk, Connecticut, United States
• GSK Investigational Site — Deerfield Beach, Florida, United States
• GSK Investigational Site — Delray Beach, Florida, United States
• GSK Investigational Site — Hialeah, Florida, United States
• GSK Investigational Site — Ocala, Florida, United States
• GSK Investigational Site — St. Petersburg, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Fort Wayne, Indiana, United States
• GSK Investigational Site — Rockville, Maryland, United States
• GSK Investigational Site — Springfield, Massachusetts, United States
• GSK Investigational Site — West Yarmouth, Massachusetts, United States
• GSK Investigational Site — Saint Paul, Minnesota, United States
• GSK Investigational Site — Morristown, New Jersey, United States
• GSK Investigational Site — Stratford, New Jersey, United States
• GSK Investigational Site — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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