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NCT00428090 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Alzheimers Disease, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
862
Enrollment target
20
Study locations

NCT00428090 is a Phase 3 study of Alzheimers Disease that has completed, run by GlaxoSmithKline. The registered enrollment target is 862 participants, below the 4,055-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00428090, a Phase 3 study of Alzheimers Disease, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
862 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Alzheimers Disease

Interventions

  • DRUG Rosiglitazone

Study Locations (20)

Florida

  • GSK Investigational Site - Deerfield Beach
  • GSK Investigational Site - Delray Beach
  • GSK Investigational Site - Destin
  • GSK Investigational Site - Hialeah
  • GSK Investigational Site - Melbourne
  • GSK Investigational Site - Plantation
  • GSK Investigational Site - Sunrise
  • GSK Investigational Site - Tampa

California

  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Newport Beach
  • GSK Investigational Site - Palo Alto
  • GSK Investigational Site - Reseda
  • GSK Investigational Site - San Diego
  • GSK Investigational Site - San Francisco

Connecticut

  • GSK Investigational Site - Fairfield
  • GSK Investigational Site - Norwalk

Arizona

  • GSK Investigational Site - Phoenix

Colorado

  • GSK Investigational Site - Denver

Georgia

  • GSK Investigational Site - Atlanta

Minnesota

  • GSK Investigational Site - Saint Paul

Trial Details

FieldValue
Enrollment Target 862 participants
Start Date 2007-02-27
Est. Completion 2008-09-05
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00428090

The ClinicalTrials.gov registry entry for NCT00428090 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 862 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,055-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (79% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which Rosiglitazone is the first listed.

NCT00428090 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT00428090 about?

NCT00428090 is a clinical study titled "Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease". 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 wi...

What is the current status of trial NCT00428090?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 862 participants. The study started on 2007-02-27. Estimated completion is 2008-09-05.

What conditions does trial NCT00428090 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT00428090?

The interventions under investigation include: Rosiglitazone (DRUG).

Who is sponsoring clinical trial NCT00428090?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00428090 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.