Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease
REFLECT-3
A 54 Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE4-stratified Subjects With Mild to Moderate Alzheimer's Disease
1 other identifier
interventional
1,468
21 countries
190
Brief Summary
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 one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. 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 the 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2006
Typical duration for phase_3
190 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedStudy Start
First participant enrolled
July 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2009
CompletedResults Posted
Study results publicly available
September 5, 2017
CompletedSeptember 5, 2017
August 1, 2017
2.7 years
June 30, 2006
April 21, 2017
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort
The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort
The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort
The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Secondary Outcomes (25)
Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36
Baseline (Week 0) and Week 8, 16, 24, 36
Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36
Baseline (Week 0) and Week 12, 24, 36
Change From Screening in Mini Mental State Examination (MMSE) Total Score
Screening (Week -4) and Week 48
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score
Baseline (Week 0) and Week 8, 16, 24, 48
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
Baseline (Week 0) and Week 8, 16, 24, 48
- +20 more secondary outcomes
Study Arms (3)
Arm 1
EXPERIMENTALRosiglitazone Extended Release 2mg OD
Arm 2
EXPERIMENTALRosiglitazone Extended Release 8mg OD
Arm 3
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2).
- (Note: National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).)
- Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 26 inclusive at Screening.
- Hachinski Ischemia Score ≤ 4 at Screening (See Appendix 3).
- Age ≥50 and ≤90 years.
- At least 6 months of ongoing acetylcholinesterase inhibitor therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
- Current use of medication is in accordance with the criteria listed in Table 2 (Permitted Medications, Section 8.1).
- Female subjects must be post-menopausal (i.e. \>1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception (Appendix 4) for the duration of the study. Female subjects who are pre-menopausal or who have been post-menopausal for \<1 year must undertake pregnancy testing (urine test) at Visit 1, which must be negative.
- Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease.
- (Note: Questionable CT or MRI scans should be discussed with the medical monitor, using central imaging guidelines.)
- Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma).
- Subject has the ability to comply with procedures for cognitive and other testing.
- Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.
- (Note: A non-cohabiting caregiver must spend sufficient time with the subject so that, in the opinion of the Investigator, the caregiver can reliably assess cognitive function, activities and behavior, and report on the subject's compliance and health. As caregiver time spent with a potential subject is anticipated to be highly variable across countries and cultures, GSK will consider a variety of different measures by which this stipulation may be met, and GSK should be consulted if adequacy of a caregiver situation is in doubt. However, as guidance, the ability for a caregiver to meet his/her expected responsibilities for this study would normally be possible when the caregiver spends no less than 10 hours per week with the subject, divided over multiple days.)
- Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
- +4 more criteria
You may not qualify if:
- Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 5).
- (Note: National Institute of Neurological Disorders and Stroke (NINDS) and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN).)
- History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
- Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH), that are clinically significant in the opinion of the investigator.
- (Note: Testing is required for each parameter only when no result is available from previous 12 months.)
- History of Type 1 diabetes mellitus or secondary diabetes mellitus.
- Type 2 diabetes mellitus where the subject is being treated with insulin, a PPARγ agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
- Any patient with an HbA1c ≥8.5%. (See Section 6.3.8.4 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus.)
- History or clinical/investigational evidence of congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status; Appendix 6).
- History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome \[non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina\] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
- History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment.
- (Note: If not currently treated, but active depression is suspected, the Cornell Scale for Depression in Dementia (CSDD, Appendix 7) can be used by the Investigator as a guide for deciding whether a prospective subject requires treatment. If the subject has a CSDD score \>7, the Investigator should decide if the subject has depression in need of prescribed medication, and a CSDD \>12 is considered a strong indicator that treatment is needed. Subjects will be allowed to re-screen after their depression has been adequately managed for \>3 months.)
- Clinically significant peripheral edema at the time of screening.
- Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia.
- Systolic blood pressure \>165 or \<90 mmHg or diastolic blood pressure \>95 or \<60 mmHg at the time of screening.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (194)
GSK Investigational Site
Sun City, Arizona, 85351, United States
GSK Investigational Site
Tucson, Arizona, 85741, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Laguna Hills, California, 92653, United States
GSK Investigational Site
Redlands, California, 92374, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Norwalk, Connecticut, 06851, United States
GSK Investigational Site
Deerfield Beach, Florida, 33064, United States
GSK Investigational Site
Delray Beach, Florida, 33445, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Hialeah, Florida, 33016, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
St. Petersburg, Florida, 33702, United States
GSK Investigational Site
Tampa, Florida, 33617, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Chicago, Illinois, 60610, United States
GSK Investigational Site
Springfield, Massachusetts, 01104, United States
GSK Investigational Site
West Yarmouth, Massachusetts, 02673, United States
GSK Investigational Site
Eatontown, New Jersey, 07724, United States
GSK Investigational Site
Toms River, New Jersey, 08755, United States
GSK Investigational Site
Whiting, New Jersey, 08759, United States
GSK Investigational Site
Amherst, New York, 14226, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Centerville, Ohio, 45459, United States
GSK Investigational Site
Columbus, Ohio, 43210, United States
GSK Investigational Site
Toledo, Ohio, 43623, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Jenkintown, Pennsylvania, 19046, United States
GSK Investigational Site
Norristown, Pennsylvania, 19401, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19102, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19115, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Wichita Falls, Texas, 76309, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Charlottesville, Virginia, 22903, United States
GSK Investigational Site
Seattle, Washington, 98108, United States
GSK Investigational Site
Middleton, Wisconsin, 53562-2215, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Hornsby, New South Wales, 2077, Australia
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
Auchenflower, Queensland, 4066, Australia
GSK Investigational Site
Chermside, Queensland, 4032, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Woodville, South Australia, 5011, Australia
GSK Investigational Site
Cheltenham, Victoria, 3192, Australia
GSK Investigational Site
Heidelberg West, Victoria, 3084, Australia
GSK Investigational Site
Kew, Victoria, 3101, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Kortrijk, 8500, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Woluwe-Saint-Lambert, 1200, Belgium
GSK Investigational Site
Sofia, 1113, Bulgaria
GSK Investigational Site
Sofia, 1431, Bulgaria
GSK Investigational Site
Sofia, 1527, Bulgaria
GSK Investigational Site
Varna, 9010, Bulgaria
GSK Investigational Site
Kelowna, British Columbia, V1W 4V5, Canada
GSK Investigational Site
Saint John, New Brunswick, E2L 3L6, Canada
GSK Investigational Site
Kentville, Nova Scotia, B4N 4K9, Canada
GSK Investigational Site
Kingston, Ontario, K7L 5G2, Canada
GSK Investigational Site
Ottawa, Ontario, K1G 4G3, Canada
GSK Investigational Site
Ottawa, Ontario, K1N 5C8, Canada
GSK Investigational Site
Peterborough, Ontario, K9H 2P4, Canada
GSK Investigational Site
Toronto, Ontario, M3B 2S7, Canada
GSK Investigational Site
Toronto, Ontario, M6M 3Z5, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2J2, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Montreal, Quebec, H4H 1R3, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1J 3H5, Canada
GSK Investigational Site
Québec, G1R 3X5, Canada
GSK Investigational Site
Olomouc, 775 20, Czechia
GSK Investigational Site
Prague, 10000, Czechia
GSK Investigational Site
Prague, 180 00, Czechia
GSK Investigational Site
Trutnov, 541 01, Czechia
GSK Investigational Site
Helsinki, 00120, Finland
GSK Investigational Site
Joensuu, 80100, Finland
GSK Investigational Site
Kuopio, 70211, Finland
GSK Investigational Site
Bordeaux, 33076, France
GSK Investigational Site
La Chapelle-sur-Erdre, 44240, France
GSK Investigational Site
La Seyne-sur-Mer, 83500, France
GSK Investigational Site
Lille, 59000, France
GSK Investigational Site
Limoges, 87042, France
GSK Investigational Site
Metz, 57000, France
GSK Investigational Site
Nantes, 44000, France
GSK Investigational Site
Nantes, 44300, France
GSK Investigational Site
Paris, 75013, France
GSK Investigational Site
Sautron, 44880, France
GSK Investigational Site
Toulon, 83000, France
GSK Investigational Site
Toulouse, 31300, France
GSK Investigational Site
Valence, 26000, France
GSK Investigational Site
Aalen, Baden-Wurttemberg, 73430, Germany
GSK Investigational Site
Calw, Baden-Wurttemberg, 75365, Germany
GSK Investigational Site
Ellwangen, Baden-Wurttemberg, 73479, Germany
GSK Investigational Site
Ludwigsburg, Baden-Wurttemberg, 71634, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70176, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89073, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89075, Germany
GSK Investigational Site
Wiesloch, Baden-Wurttemberg, 69168, Germany
GSK Investigational Site
Alzenau in Unterfranken, Bavaria, 63755, Germany
GSK Investigational Site
Munich, Bavaria, 81675, Germany
GSK Investigational Site
Unterhaching, Bavaria, 82008, Germany
GSK Investigational Site
Bad Saarow, Brandenburg, 15526, Germany
GSK Investigational Site
Bad Homburg, Hesse, 61348, Germany
GSK Investigational Site
Erbach im Odenwald, Hesse, 64711, Germany
GSK Investigational Site
Chemnitz, Saxony, 09111, Germany
GSK Investigational Site
Dresden, Saxony, 01097, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Leipzig, Saxony, 04107, Germany
GSK Investigational Site
Leipzig, Saxony, 04157, Germany
GSK Investigational Site
Gera, Thuringia, 07551, Germany
GSK Investigational Site
Jena, Thuringia, 07743, Germany
GSK Investigational Site
Berlin, 10625, Germany
GSK Investigational Site
Berlin, 12163, Germany
GSK Investigational Site
Berlin, 12167, Germany
GSK Investigational Site
Berlin, 12555, Germany
GSK Investigational Site
Berlin, 13053, Germany
GSK Investigational Site
Berlin, 13125, Germany
GSK Investigational Site
Berlin, 13156, Germany
GSK Investigational Site
Berlin, 13187, Germany
GSK Investigational Site
Berlin, 13357, Germany
GSK Investigational Site
Berlin, 13439, Germany
GSK Investigational Site
Berlin, 13507, Germany
GSK Investigational Site
Berlin, 14163, Germany
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Bandar Tun Razak, Cheras, 50586, Malaysia
GSK Investigational Site
Bandar Tun Razak, Cheras, 59100, Malaysia
GSK Investigational Site
Ipoh, 30990, Malaysia
GSK Investigational Site
Kelantan, 16150, Malaysia
GSK Investigational Site
's-Hertogenbosch, 5232 JL, Netherlands
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Blaricum, 1261 AN, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Hilversum, 1213 XZ, Netherlands
GSK Investigational Site
The Hague, 2545 CH, Netherlands
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Pasig, 1600, Philippines
GSK Investigational Site
Bydgoszcz, 85-796, Poland
GSK Investigational Site
Krakow, 31-530, Poland
GSK Investigational Site
Torun, 87-100, Poland
GSK Investigational Site
Warsaw, 02-097, Poland
GSK Investigational Site
Singapore, 169608, Singapore
GSK Investigational Site
Singapore, 308433, Singapore
GSK Investigational Site
Singapore, 539747, Singapore
GSK Investigational Site
Bratislava, 811 01, Slovakia
GSK Investigational Site
Bratislava, 811 07, Slovakia
GSK Investigational Site
Bratislava, 825 56, Slovakia
GSK Investigational Site
Košice, 041 66, Slovakia
GSK Investigational Site
Ljubljana, 1000, Slovenia
GSK Investigational Site
Šempeter v Savinj. Dolini, 5290, Slovenia
GSK Investigational Site
Loeventstein, 7530, South Africa
GSK Investigational Site
Oakdale, 7530, South Africa
GSK Investigational Site
Richards Bay, 3900, South Africa
GSK Investigational Site
Rosebank, 2196, South Africa
GSK Investigational Site
Somerset West, 7130, South Africa
GSK Investigational Site
Waverley, Bloemfontein, 9301, South Africa
GSK Investigational Site
Willows, X14, Pretoria, 0040, South Africa
GSK Investigational Site
Seongnam-si, 463-707, South Korea
GSK Investigational Site
Seoul, 138-736, South Korea
GSK Investigational Site
Seoul, 150-713, South Korea
GSK Investigational Site
Baracaldo/Vizcaya, 48903, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08014, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08907, Spain
GSK Investigational Site
Palma de Mallorca, 07014, Spain
GSK Investigational Site
Tarrasa, Barcelona, 08221, Spain
GSK Investigational Site
Falköping, SE-521 85, Sweden
GSK Investigational Site
Jönköping, SE-551 85, Sweden
GSK Investigational Site
Kalix, SE-952 82, Sweden
GSK Investigational Site
Mölndal, SE-431 41, Sweden
GSK Investigational Site
Sundsvall, SE-851 86, Sweden
GSK Investigational Site
Umeå, SE-901 85, Sweden
GSK Investigational Site
Blackpool, Lancashire, FY2 0JH, United Kingdom
GSK Investigational Site
Bradford, BD3 0DQ, United Kingdom
GSK Investigational Site
Liverpool, L9 7LJ, United Kingdom
GSK Investigational Site
Stirling, FK8 1RW, United Kingdom
GSK Investigational Site
West End, Southampton, SO30 3JB, United Kingdom
GSK Investigational Site
West of Scotland Science Park, Glasgow, G20 0XA, United Kingdom
Related Publications (1)
Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.
PMID: 21592048BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2006
First Posted
July 4, 2006
Study Start
July 12, 2006
Primary Completion
March 20, 2009
Study Completion
March 20, 2009
Last Updated
September 5, 2017
Results First Posted
September 5, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.