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Completed Phase 3 Interventional Results available

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

ClinicalTrials.gov ID: NCT00428090

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.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 6:17 AM EDT

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
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
862 participants

Conditions and interventions

Interventions

Drug

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 26, 2007
Primary completion
Aug 31, 2008
Completion
Sep 4, 2008
Last update posted
May 18, 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 18, 2017 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00428090 live on ClinicalTrials.gov.

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