Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
Public ClinicalTrials.gov record NCT00428090. 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 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease. (REFLECT-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce 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 from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.
Study identification
- NCT ID
- NCT00428090
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 862 participants
Conditions and interventions
Conditions
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
- Feb 27, 2007 (Type not available)
- Primary completion
- Sep 1, 2008 (Actual)
- Completion
- Sep 5, 2008 (Actual)
- Last update posted
- May 19, 2017
2007 – 2008
United States locations
- U.S. sites
- 41
- U.S. states
- 16
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85004 | — |
| GSK Investigational Site | Los Angeles | California | 90036 | — |
| GSK Investigational Site | Newport Beach | California | 92660 | — |
| GSK Investigational Site | Palo Alto | California | 94305 | — |
| GSK Investigational Site | Reseda | California | 91355 | — |
| GSK Investigational Site | San Diego | California | 92120 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | Denver | Colorado | 80218 | — |
| GSK Investigational Site | Fairfield | Connecticut | 06824 | — |
| GSK Investigational Site | Norwalk | Connecticut | 06851 | — |
| GSK Investigational Site | Deerfield Beach | Florida | 33064 | — |
| GSK Investigational Site | Delray Beach | Florida | 33445 | — |
| GSK Investigational Site | Destin | Florida | 32541 | — |
| GSK Investigational Site | Hialeah | Florida | 33016 | — |
| GSK Investigational Site | Melbourne | Florida | 32901 | — |
| GSK Investigational Site | Plantation | Florida | 33317 | — |
| GSK Investigational Site | Sunrise | Florida | 33351 | — |
| GSK Investigational Site | Tampa | Florida | 33647 | — |
| GSK Investigational Site | Atlanta | Georgia | 30033 | — |
| GSK Investigational Site | Saint Paul | Minnesota | 55101 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89146 | — |
| GSK Investigational Site | Kenilworth | New Jersey | 07033 | — |
| GSK Investigational Site | Toms River | New Jersey | 08755 | — |
| GSK Investigational Site | Albany | New York | 12208 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Centerville | Ohio | 45459 | — |
| GSK Investigational Site | Cleveland | Ohio | 44120 | — |
| GSK Investigational Site | Cleveland | Ohio | 44195 | — |
| GSK Investigational Site | Toledo | Ohio | 43623 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73118 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Jenkintown | Pennsylvania | 19046 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| GSK Investigational Site | Memphis | Tennessee | 35105 | — |
| GSK Investigational Site | Nashville | Tennessee | 37212 | — |
| GSK Investigational Site | DeSoto | Texas | 75115 | — |
| GSK Investigational Site | San Antonio | Texas | 78229-3900 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Middleton | Wisconsin | 53562-2215 | — |
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 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00428090, 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 May 19, 2017 · Synced Oct 25, 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 NCT00428090 live on ClinicalTrials.gov.