Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease
Public ClinicalTrials.gov record NCT00348140. 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
A 54 Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE4-stratified Subjects With Mild to Moderate Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.
Study identification
- NCT ID
- NCT00348140
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,468 participants
Conditions and interventions
Conditions
Interventions
Drug · Other
Eligibility (public fields only)
- Age range
- 50 Years to 90 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
- Jul 12, 2006 (Actual)
- Primary completion
- Mar 20, 2009 (Actual)
- Completion
- Mar 20, 2009 (Actual)
- Last update posted
- Sep 5, 2017
2006 – 2009
United States locations
- U.S. sites
- 49
- U.S. states
- 21
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Sun City | Arizona | 85351 | — |
| GSK Investigational Site | Tucson | Arizona | 85741 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Laguna Hills | California | 92653 | — |
| GSK Investigational Site | Redlands | California | 92374 | — |
| GSK Investigational Site | San Diego | California | 92103 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | Norwalk | Connecticut | 06851 | — |
| GSK Investigational Site | Deerfield Beach | Florida | 33064 | — |
| GSK Investigational Site | Delray Beach | Florida | 33445 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | — |
| GSK Investigational Site | Hialeah | Florida | 33016 | — |
| GSK Investigational Site | Ocala | Florida | 34471 | — |
| GSK Investigational Site | St. Petersburg | Florida | 33702 | — |
| GSK Investigational Site | Tampa | Florida | 33617 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Chicago | Illinois | 60610 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01104 | — |
| GSK Investigational Site | West Yarmouth | Massachusetts | 02673 | — |
| GSK Investigational Site | Eatontown | New Jersey | 07724 | — |
| GSK Investigational Site | Toms River | New Jersey | 08755 | — |
| GSK Investigational Site | Whiting | New Jersey | 08759 | — |
| GSK Investigational Site | Amherst | New York | 14226 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | Rochester | New York | 14620 | — |
| 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 | Centerville | Ohio | 45459 | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Toledo | Ohio | 43623 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Jenkintown | Pennsylvania | 19046 | — |
| GSK Investigational Site | Norristown | Pennsylvania | 19401 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19115 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| GSK Investigational Site | East Providence | Rhode Island | 02914 | — |
| GSK Investigational Site | Providence | Rhode Island | 02906 | — |
| GSK Investigational Site | Greer | South Carolina | 29651 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Wichita Falls | Texas | 76309 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | — |
| GSK Investigational Site | Seattle | Washington | 98108 | — |
| GSK Investigational Site | Middleton | Wisconsin | 53562-2215 | — |
| 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 145 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00348140, 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 Sep 5, 2017 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00348140 live on ClinicalTrials.gov.