Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease
Public ClinicalTrials.gov record NCT00348309. 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, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Donepezil on Cognition and Overall Clinical Response in APOE ε4-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 the currently approved AD medication, Aricept (donepezil). 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 their 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
- NCT00348309
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,496 participants
Conditions and interventions
Conditions
Interventions
- Rosiglitazone Extended Release 2mg Drug
- Rosiglitazone Extended Release 8mg Drug
- Placebo Other
- Donepezil Other
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 5, 2006
- Primary completion
- Dec 31, 2008
- Completion
- Jan 27, 2009
- Last update posted
- Nov 27, 2017
2006 – 2009
United States locations
- U.S. sites
- 41
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Litchfield Park | Arizona | 85340 | — |
| GSK Investigational Site | Phoenix | Arizona | 85004 | — |
| GSK Investigational Site | Phoenix | Arizona | 85006 | — |
| GSK Investigational Site | Phoenix | Arizona | 85050 | — |
| 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 | Sherman Oaks | California | 91403 | — |
| GSK Investigational Site | Denver | Colorado | 80212 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Delray Beach | Florida | 33445 | — |
| GSK Investigational Site | Hallandale | Florida | 33009 | — |
| GSK Investigational Site | Miami | Florida | 33143 | — |
| GSK Investigational Site | Sarasota | Florida | 34233 | — |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | — |
| GSK Investigational Site | Hoffman Estates | Illinois | 60194 | — |
| GSK Investigational Site | Fort Wayne | Indiana | 46805 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Baltimore | Maryland | 21224 | — |
| GSK Investigational Site | Glen Burnie | Maryland | 21061 | — |
| GSK Investigational Site | Rockville | Maryland | 20852 | — |
| GSK Investigational Site | Saint Paul | Minnesota | 55101 | — |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | — |
| GSK Investigational Site | Morristown | New Jersey | 07960 | — |
| GSK Investigational Site | Nutley | New Jersey | 07110 | — |
| GSK Investigational Site | Princeton | New Jersey | 08540 | — |
| GSK Investigational Site | Stratford | New Jersey | 08084 | — |
| GSK Investigational Site | Albany | New York | 12205 | — |
| GSK Investigational Site | Brooklyn | New York | 11235 | — |
| GSK Investigational Site | New York | New York | 10021 | — |
| GSK Investigational Site | Durham | North Carolina | 27705 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Portland | Oregon | 97239 | — |
| GSK Investigational Site | Providence | Rhode Island | 02906 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Austin | Texas | 78757 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | South Ogden | Utah | 84403 | — |
| GSK Investigational Site | Bennington | Vermont | 05201 | — |
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 208 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00348309, 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 27, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00348309 live on ClinicalTrials.gov.