Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00428090
First received: January 25, 2007
Last updated: September 6, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Rosiglitazone XR (extended release) oral tablets |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Change from baseline in ADAS-Cog total score and CIBIC+ score at Week 24, as a function of APOE e4 status.
Secondary Outcome Measures:
- Visits Week 4 to 24:changes in behavior, activities of daily living, healthcare resource utilization, subject/ caregiver quality of life, pharmacokinetics, exploratory pharmacogenetics, proteomics/transcriptomics. [ Time Frame: 24 Weeks ]
- The following endpoints will be analyzed according to a prioritized hierarchy to preserve the type I error rate :
- Change from baseline in ADAS-Cog total score for observed cases at Weeks 8, 16 and 24.
- Change from baseline in CIBIC+ score for observed cases at Weeks 8, 16 and 24.
- Change from baseline in Neuropsychiatric Inventory (NPI; [Cummings, 1994]) total score.
- Change from baseline in Disability Assessment for Dementia scale (DAD; [Gelinas, 1999]) total score.
- Combined analysis of Items 1 and 7 of ADAS-Cog to yield Short Term Memory Assessment
- Change from baseline in European Quality of Life -5 Dimensions Proxy (EQ-5D Proxy) scale [The EuroQol Group, 1990] total score.
- Domains of the Resource Utilization in Dementia scale (RUD; [Wimo, 1998]).
- Change from baseline in Alzheimer's Carer's Quality of Life Instrument (ACQLI, [Doward, 1997]) score.
- Change from baseline in Mini Mental State Examination (MMSE) [Folstein, 1975] total score.
- Change from baseline in HbA1c at Week 24.
| Estimated Enrollment: | 862 |
| Study Start Date: | February 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Rosiglitazone XR (extended release) oral tablets
Other Name: Rosiglitazone XR (extended release) oral tablets
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)
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428090
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| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85004 | |
| United States, California | |
| GSK Investigational Site | |
| Newport Beach, California, United States, 92660 | |
| GSK Investigational Site | |
| Palo Alto, California, United States, 94305 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92120 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Fairfield, Connecticut, United States, 06824 | |
| GSK Investigational Site | |
| Norwalk, Connecticut, United States, 06851 | |
| United States, Florida | |
| GSK Investigational Site | |
| Deerfield Beach, Florida, United States, 33064 | |
| GSK Investigational Site | |
| Delray Beach, Florida, United States, 33445 | |
| GSK Investigational Site | |
| Destin, Florida, United States, 32541 | |
| GSK Investigational Site | |
| Hialeah, Florida, United States, 33016 | |
| GSK Investigational Site | |
| Melbourne, Florida, United States, 32901 | |
| GSK Investigational Site | |
| Plantation, Florida, United States, 33317 | |
| GSK Investigational Site | |
| Sunrise, Florida, United States, 33351 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89146 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Kenilworth, New Jersey, United States, 07033 | |
| GSK Investigational Site | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| GSK Investigational Site | |
| Albany, New York, United States, 12208 | |
| GSK Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Centerville, Ohio, United States, 45459 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44120 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| GSK Investigational Site | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Memphis, Tennessee, United States, 35105 | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| GSK Investigational Site | |
| DeSoto, Texas, United States, 75115 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Middleton, Wisconsin, United States, 53562-2215 | |
| Austria | |
| GSK Investigational Site | |
| Graz-Eggenberg, Austria, A-8020 | |
| GSK Investigational Site | |
| Hall in Tirol, Austria, A-6060 | |
| GSK Investigational Site | |
| Linz, Austria, A-4020 | |
| GSK Investigational Site | |
| Linz, Austria, 4020 | |
| GSK Investigational Site | |
| Vienna, Austria, A-1090 | |
| Bulgaria | |
| GSK Investigational Site | |
| Plovdiv, Bulgaria, 4000 | |
| GSK Investigational Site | |
| Sofia, Bulgaria, 1113 | |
| GSK Investigational Site | |
| Sofia, Bulgaria, 1527 | |
| GSK Investigational Site | |
| Sofia, Bulgaria, 1431 | |
| Chile | |
| GSK Investigational Site | |
| Providencia / Santiago, Región Metro De Santiago, Chile, 7500710 | |
| GSK Investigational Site | |
| Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257 | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7560356 | |
| GSK Investigational Site | |
| Viña del Mar, Valparaíso, Chile, 252-0997 | |
| China | |
| GSK Investigational Site | |
| Beijing, China, 100083 | |
| GSK Investigational Site | |
| Beijing, China, 100730 | |
| GSK Investigational Site | |
| Shanghai, China, 200030 | |
| GSK Investigational Site | |
| Shanghai, China, 200025 | |
| GSK Investigational Site | |
| Shanghai, China, 200040 | |
| GSK Investigational Site | |
| Tianjin, China, 300052 | |
| Croatia | |
| GSK Investigational Site | |
| Dubrovnik, Croatia, 20000 | |
| GSK Investigational Site | |
| Zagreb, Croatia, 10000 | |
| Estonia | |
| GSK Investigational Site | |
| Tallinn, Estonia, 10617 | |
| GSK Investigational Site | |
| Tallinn, Estonia, 10614 | |
| GSK Investigational Site | |
| Tallinn, Estonia, 10138 | |
| GSK Investigational Site | |
| Tartu, Estonia, 51014 | |
| Germany | |
| GSK Investigational Site | |
| Ellwangen, Baden-Wuerttemberg, Germany, 73479 | |
| GSK Investigational Site | |
| Tuebingen, Baden-Wuerttemberg, Germany, 72076 | |
| GSK Investigational Site | |
| Ulm, Baden-Wuerttemberg, Germany, 89075 | |
| GSK Investigational Site | |
| Ulm, Baden-Wuerttemberg, Germany, 89073 | |
| GSK Investigational Site | |
| Guenzburg, Bayern, Germany, 89312 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80331 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81675 | |
| GSK Investigational Site | |
| Nuernberg, Bayern, Germany, 90402 | |
| GSK Investigational Site | |
| Unterhaching, Bayern, Germany, 82008 | |
| GSK Investigational Site | |
| Bad Homburg, Hessen, Germany, 61348 | |
| GSK Investigational Site | |
| Schwerin, Mecklenburg-Vorpommern, Germany, 19053 | |
| GSK Investigational Site | |
| Schwerin, Mecklenburg-Vorpommern, Germany, 19055 | |
| GSK Investigational Site | |
| Achim, Niedersachsen, Germany, 28832 | |
| GSK Investigational Site | |
| Hannover, Niedersachsen, Germany, 30559 | |
| GSK Investigational Site | |
| Baesweiler, Nordrhein-Westfalen, Germany, 52499 | |
| GSK Investigational Site | |
| Bielefeld, Nordrhein-Westfalen, Germany, 33647 | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44892 | |
| GSK Investigational Site | |
| Duisburg, Nordrhein-Westfalen, Germany, 47051 | |
| GSK Investigational Site | |
| Juelich, Nordrhein-Westfalen, Germany, 52428 | |
| GSK Investigational Site | |
| Koeln, Nordrhein-Westfalen, Germany, 50767 | |
| GSK Investigational Site | |
| Halle, Sachsen-Anhalt, Germany, 06122 | |
| GSK Investigational Site | |
| Chemnitz, Sachsen, Germany, 09111 | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01097 | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01307 | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04103 | |
| GSK Investigational Site | |
| Gera, Thueringen, Germany, 07551 | |
| GSK Investigational Site | |
| Berlin, Germany, 13507 | |
| GSK Investigational Site | |
| Berlin, Germany, 13125 | |
| GSK Investigational Site | |
| Berlin, Germany, 12163 | |
| GSK Investigational Site | |
| Berlin, Germany, 12167 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22143 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22083 | |
| GSK Investigational Site | |
| Hamburg, Germany, 20249 | |
| Greece | |
| GSK Investigational Site | |
| Athens, Greece, 115 21 | |
| GSK Investigational Site | |
| Melissia, Greece, 151 27 | |
| GSK Investigational Site | |
| Thessaloniki, Greece, 57010 | |
| Hungary | |
| GSK Investigational Site | |
| Gyula, Hungary, 5700 | |
| GSK Investigational Site | |
| Pécs, Hungary, 7623 | |
| GSK Investigational Site | |
| Szeged, Hungary, 6725 | |
| Korea, Republic of | |
| GSK Investigational Site | |
| Seongnam-si,, Korea, Republic of, 463-707 | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 143-729 | |
| New Zealand | |
| GSK Investigational Site | |
| Auckland, New Zealand, 0622 | |
| Peru | |
| GSK Investigational Site | |
| Lima, Peru, Lima 13 | |
| Philippines | |
| GSK Investigational Site | |
| Pasig City, Philippines, 1600 | |
| GSK Investigational Site | |
| Quezon City, Philippines, 1102 | |
| Puerto Rico | |
| GSK Investigational Site | |
| Cabo Rojo, Puerto Rico, 623 | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 90660 | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00918 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115552 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 197022 | |
| GSK Investigational Site | |
| St.-Petersburg, Russian Federation, 198103 | |
| United Kingdom | |
| GSK Investigational Site | |
| Bradford, United Kingdom, BD3 0DQ | |
| GSK Investigational Site | |
| West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00428090 History of Changes |
| Other Study ID Numbers: | 105640 |
| Study First Received: | January 25, 2007 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
apolipoprotein E monotherapy cognition mild |
rosiglitazone Alzheimer's disease moderate |
Additional relevant MeSH terms:
|
Alzheimer Disease Rosiglitazone Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013