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

NCT ID: NCT00428090

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-27
• Study Completion Date: 2008-09-05

Brief 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.

Detailed Description

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 e4-stratified subjects with mild to moderate Alzheimer's disease. (REFLECT-1)

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rosiglitazone

XR (extended release) oral tablets

Group Type: EXPERIMENTAL

Rosiglitazone

Intervention Type: DRUG

XR (extended release) oral tablets

Placebo

Placebo (Double-Dummy to Match)

Group Type: OTHER

Rosiglitazone

Intervention Type: DRUG

XR (extended release) oral tablets

Interventions

Rosiglitazone

XR (extended release) oral tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of probable Alzheimer's Disease (AD).
• MMSE score 10 to 23
• Has not taken an approved AD therapy in last 30 days.
• No previous hypersensitivity/intolerance to AChEIs
• Have a regular caregiver.

Exclusion Criteria

• Diagnosis of vascular dementia.
• Type I or secondary diabetes mellitus.
• Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
• History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
• History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Palo Alto, California, United States

GSK Investigational Site

Reseda, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Fairfield, Connecticut, United States

GSK Investigational Site

Norwalk, Connecticut, United States

GSK Investigational Site

Deerfield Beach, Florida, United States

GSK Investigational Site

Delray Beach, Florida, United States

GSK Investigational Site

Destin, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Melbourne, Florida, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

Sunrise, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Saint Paul, Minnesota, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Kenilworth, New Jersey, United States

GSK Investigational Site

Toms River, New Jersey, United States

GSK Investigational Site

Albany, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Centerville, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Toledo, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Jenkintown, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Memphis, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

DeSoto, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Middleton, Wisconsin, United States

GSK Investigational Site

Graz-Eggenberg, , Austria

GSK Investigational Site

Hall in Tirol, , Austria

GSK Investigational Site

Linz, , Austria

GSK Investigational Site

Linz, , Austria

GSK Investigational Site

Vienna, , Austria

GSK Investigational Site

Vienna, , Austria

GSK Investigational Site

Vienna, , Austria

GSK Investigational Site

Plovdiv, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Guangzhou, Guangdong, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Tianjin, , China

GSK Investigational Site

Dubrovnik, , Croatia

GSK Investigational Site

Zagreb, , Croatia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Ellwangen, Baden-Wurttemberg, Germany

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Günzburg, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nuremberg, Bavaria, Germany

GSK Investigational Site

Unterhaching, Bavaria, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Bad Homburg, Hesse, Germany

GSK Investigational Site

Achim, Lower Saxony, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Baesweiler, North Rhine-Westphalia, Germany

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

GSK Investigational Site

Jülich, North Rhine-Westphalia, Germany

GSK Investigational Site

Chemnitz, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

GSK Investigational Site

Itzehoe, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Gera, Thuringia, Germany

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Melíssia, , Greece

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Budapest, , Hungary

GSK Investigational Site

Gyula, , Hungary

GSK Investigational Site

Kaposvár, , Hungary

GSK Investigational Site

Pécs, , Hungary

GSK Investigational Site

Szeged, , Hungary

GSK Investigational Site

Bangalore, , India

GSK Investigational Site

Nagpur, , India

GSK Investigational Site

Tirupati, , India

GSK Investigational Site

Saltillo, Coahuila, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

México, , Mexico

GSK Investigational Site

Auckland, , New Zealand

GSK Investigational Site

Karachi, , Pakistan

GSK Investigational Site

Lahore, , Pakistan

GSK Investigational Site

Lahore, , Pakistan

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Pasig, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Cabo Rojo, Puerto Rico, Puerto Rico

GSK Investigational Site

San Juan, Puerto Rico, Puerto Rico

GSK Investigational Site

San Juan, Puerto Rico, Puerto Rico

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Seongnam-si, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Bradford, , United Kingdom

GSK Investigational Site

Derriford, Plymouth, , United Kingdom

GSK Investigational Site

West of Scotland Science Park, Glasgow, , United Kingdom

Countries

United States; Austria; Bulgaria; Chile; China; Croatia; Estonia; Germany; Greece; Hungary; India; Mexico; New Zealand; Pakistan; Peru; Philippines; Puerto Rico; Russia; South Korea; United Kingdom

References

Gold M, Alderton C, Zvartau-Hind M, Egginton S, Saunders AM, Irizarry M, Craft S, Landreth G, Linnamagi U, Sawchak S. Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: results from a randomized, double-blind, placebo-controlled phase III study. Dement Geriatr Cogn Disord. 2010;30(2):131-46. doi: 10.1159/000318845. Epub 2010 Aug 21.

Reference Type: BACKGROUND

PMID: 20733306 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

105640

Identifier Type: -

Identifier Source: org_study_id