Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Public ClinicalTrials.gov record NCT00490568. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00490568
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,461 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 51 Years to 91 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 8, 2007 (Actual)
- Primary completion
- Jun 1, 2009 (Actual)
- Completion
- Jun 1, 2009 (Actual)
- Last update posted
- Nov 13, 2017
2007 – 2009
United States locations
- U.S. sites
- 41
- U.S. states
- 20
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Litchfield Park | Arizona | 85340 | — |
| GSK Investigational Site | Phoenix | Arizona | 85013 | — |
| GSK Investigational Site | Tucson | Arizona | 85741 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Fresno | California | 93720 | — |
| GSK Investigational Site | Rancho Mirage | California | 92270 | — |
| GSK Investigational Site | Sacramento | California | 95816 | — |
| GSK Investigational Site | San Diego | California | 92103 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | Sherman Oaks | California | 91403 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Norwalk | Connecticut | 06851 | — |
| GSK Investigational Site | Deerfield Beach | Florida | 33064 | — |
| GSK Investigational Site | Delray Beach | Florida | 33445 | — |
| GSK Investigational Site | Hialeah | Florida | 33016 | — |
| GSK Investigational Site | Ocala | Florida | 34471 | — |
| GSK Investigational Site | St. Petersburg | Florida | 33702 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | — |
| GSK Investigational Site | Fort Wayne | Indiana | 46805 | — |
| GSK Investigational Site | Rockville | Maryland | 20852 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01104 | — |
| GSK Investigational Site | West Yarmouth | Massachusetts | 02673 | — |
| GSK Investigational Site | Saint Paul | Minnesota | 55101 | — |
| GSK Investigational Site | Morristown | New Jersey | 07960 | — |
| GSK Investigational Site | Stratford | New Jersey | 08084 | — |
| GSK Investigational Site | Toms River | New Jersey | 08755 | — |
| GSK Investigational Site | Albany | New York | 12205 | — |
| GSK Investigational Site | Brooklyn | New York | 11235 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Toledo | Ohio | 43623 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| GSK Investigational Site | Providence | Rhode Island | 02906 | — |
| GSK Investigational Site | Austin | Texas | 78757 | — |
| GSK Investigational Site | South Ogden | Utah | 84403 | — |
| GSK Investigational Site | Bennington | Vermont | 05201 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 231 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00490568, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 13, 2017 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00490568 live on ClinicalTrials.gov.