Last reviewed · How we verify
Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers
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 AVA105640. 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. 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 AVA105640. 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
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | PHASE3 |
| Status | TERMINATED |
| Enrolment | 331 |
| Start date | Mon Oct 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Feb 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Alzheimer's Disease
Interventions
- Rosiglitazone XR
Countries
New Zealand, Russia, Greece, Peru, Chile, Austria, Estonia, United Kingdom, Germany, Hungary, Mexico, Philippines, South Korea, Puerto Rico, Bulgaria, China, Croatia, United States