Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease
REFLECT-2
A 54-week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Donepezil on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease.
1 other identifier
interventional
1,496
19 countries
249
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 the currently approved AD medication, Aricept (donepezil). 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 their 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 not_applicable
Started Jul 2006
Typical duration for not_applicable
249 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 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2009
CompletedResults Posted
Study results publicly available
November 28, 2017
CompletedNovember 28, 2017
September 1, 2017
2.5 years
June 30, 2006
April 21, 2017
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48
ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in participants with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4's: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups. Least square mean is entered for adjusted mean.
Baseline (Week 0) and Week 48
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4's: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups.
Baseline (Week 0) and Week 48
Secondary Outcomes (20)
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score
Baseline (Week 0), Week 8, 16, 24 and 48
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
Baseline (Week 0), Week 8, 16, 24 and 48
Change From Screening in Mini Mental State Examination (MMSE) Total Score
Screening (Week -4) and Week 48
Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)
Baseline (Week 0), Week 12, 24, 36 and 48
Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility
Baseline (Week 0), Week 12, 36 and 48
- +15 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
Donepezil (At least 6 months of ongoing donepezil 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).
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.
- (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.
- Age ≥50 and ≤90 years.
- At least 6 months of ongoing donepezil 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,).
- Female subjects must be post-menopausal (i.e. \>1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception 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.
- (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 6.3.7.4 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;).
- 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) 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 (249)
GSK Investigational Site
Litchfield Park, Arizona, 85340, United States
GSK Investigational Site
Phoenix, Arizona, 85004, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Rancho Mirage, California, 92270, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
Sherman Oaks, California, 91403, United States
GSK Investigational Site
Denver, Colorado, 80212, United States
GSK Investigational Site
New Haven, Connecticut, 06510, United States
GSK Investigational Site
Delray Beach, Florida, 33445, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Sarasota, Florida, 34233, United States
GSK Investigational Site
St. Petersburg, Florida, 33701, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Hoffman Estates, Illinois, 60194, United States
GSK Investigational Site
Fort Wayne, Indiana, 46805, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Baltimore, Maryland, 21224, United States
GSK Investigational Site
Glen Burnie, Maryland, 21061, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Saint Paul, Minnesota, 55101, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Morristown, New Jersey, 07960, United States
GSK Investigational Site
Nutley, New Jersey, 07110, United States
GSK Investigational Site
Princeton, New Jersey, 08540, United States
GSK Investigational Site
Stratford, New Jersey, 08084, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
Brooklyn, New York, 11235, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Austin, Texas, 78757, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
South Ogden, Utah, 84403, United States
GSK Investigational Site
Bennington, Vermont, 05201, United States
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1192AAW, Argentina
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1419HDN, Argentina
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, C1431FWO, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, 5000, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5004AOA, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, x5009bin, Argentina
GSK Investigational Site
Godoy Cruz, Mendoza Province, M5504FMI, Argentina
GSK Investigational Site
Buenos Aires, C1425CDC, Argentina
GSK Investigational Site
Mendoza, CPM5500HIF, Argentina
GSK Investigational Site
Hall in Tirol, A-6060, Austria
GSK Investigational Site
Innsbruck, A-6020, Austria
GSK Investigational Site
Vienna, 1010, Austria
GSK Investigational Site
Vienna, 1030, Austria
GSK Investigational Site
Vienna, A-1130, Austria
GSK Investigational Site
Vienna, A-1220, Austria
GSK Investigational Site
Belo Horizonte, 30130-110, Brazil
GSK Investigational Site
Ribeirão Preto, 14048-900, Brazil
GSK Investigational Site
São Paulo, 040023-900, Brazil
GSK Investigational Site
Calgary, Alberta, T2N 4N1, Canada
GSK Investigational Site
Medicine Hat, Alberta, T1A 4C2, Canada
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Victoria, British Columbia, V8T 5G1, Canada
GSK Investigational Site
Moncton, New Brunswick, E1C 4B7, Canada
GSK Investigational Site
Barrie, Ontario, L4M 4S5, Canada
GSK Investigational Site
Kingston, Ontario, K7L 4X3, Canada
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Peterborough, Ontario, K9H 2P4, Canada
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Toronto, Ontario, M5T 2S8, Canada
GSK Investigational Site
Toronto, Ontario, M6M 3Z5, Canada
GSK Investigational Site
Whitby, Ontario, L1N 5S9, Canada
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 5Y8, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2J2, Canada
GSK Investigational Site
Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4H 1R3, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
GSK Investigational Site
Regina, Saskatchewan, S4T 1A5, Canada
GSK Investigational Site
Québec, G1R 3X5, Canada
GSK Investigational Site
Viña del Mar, Región de Valparaíso, 252-0997, Chile
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710, Chile
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7560356, Chile
GSK Investigational Site
Ostrava, 702 00, Czechia
GSK Investigational Site
Prague, 10000, Czechia
GSK Investigational Site
Prague, 120 00, Czechia
GSK Investigational Site
Prague, 150 18, Czechia
GSK Investigational Site
Prague, 170 00, Czechia
GSK Investigational Site
Angoulême, 16000, France
GSK Investigational Site
Arcachon, 33120, France
GSK Investigational Site
Avignon, 84000, France
GSK Investigational Site
Bourg-en-Bresse, 01012, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Dijon, 21000, France
GSK Investigational Site
Issy-les-Moulineaux, 92130, France
GSK Investigational Site
Ivry, 94206, France
GSK Investigational Site
Luynes, 37230, France
GSK Investigational Site
Lyon, 69006, France
GSK Investigational Site
Marseille, 13008, France
GSK Investigational Site
Marseille, 13009, France
GSK Investigational Site
Metz, 57038, France
GSK Investigational Site
Montpellier, 34080, France
GSK Investigational Site
Nantes, 44000, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Nantes, 44200, France
GSK Investigational Site
Nice, 06002, France
GSK Investigational Site
Paris, 75012, France
GSK Investigational Site
Paris, 75013, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Pau, 64000, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Reims, 51100, France
GSK Investigational Site
Rennes, 35000, France
GSK Investigational Site
Rodez, 12000, France
GSK Investigational Site
Saint-Etienne, 42100, France
GSK Investigational Site
Saint-Jean-de-Luz, 64500, France
GSK Investigational Site
Saint-Nicolas-de-Port, 54210, France
GSK Investigational Site
Saint-Ouen-la-Rouërie, 35460, France
GSK Investigational Site
Tinténiac, 35190, France
GSK Investigational Site
Tours, 37100, France
GSK Investigational Site
Verny, 57420, France
GSK Investigational Site
Vichy, 03200, France
GSK Investigational Site
Böblingen, Baden-Wurttemberg, 71034, Germany
GSK Investigational Site
Ostfildern, Baden-Wurttemberg, 73760, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70178, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89073, Germany
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Munich, Bavaria, 80333, Germany
GSK Investigational Site
Munich, Bavaria, 80336, Germany
GSK Investigational Site
Munich, Bavaria, 81377, Germany
GSK Investigational Site
Munich, Bavaria, 81667, Germany
GSK Investigational Site
Neuburg an der Donau, Bavaria, 86633, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90402, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90403, Germany
GSK Investigational Site
Regensburg, Bavaria, 93053, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Hüttenberg, Hesse, 35625, Germany
GSK Investigational Site
Achim, Lower Saxony, 28832, Germany
GSK Investigational Site
Bockhorn, Lower Saxony, 26345, Germany
GSK Investigational Site
Ganderkesee, Lower Saxony, 27777, Germany
GSK Investigational Site
Göttingen, Lower Saxony, 37075, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30559, Germany
GSK Investigational Site
Hildesheim, Lower Saxony, 31134, Germany
GSK Investigational Site
Lüneburg, Lower Saxony, 21335, Germany
GSK Investigational Site
Westerstede, Lower Saxony, 26655, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19053, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
GSK Investigational Site
Bad Honnef, North Rhine-Westphalia, 53604, Germany
GSK Investigational Site
Baesweiler, North Rhine-Westphalia, 52499, Germany
GSK Investigational Site
Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44805, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44809, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44869, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44892, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50767, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47051, Germany
GSK Investigational Site
Düren, North Rhine-Westphalia, 52349, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45138, Germany
GSK Investigational Site
Hattingen, North Rhine-Westphalia, 45525, Germany
GSK Investigational Site
Jülich, North Rhine-Westphalia, 52428, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47800, Germany
GSK Investigational Site
Remscheid, North Rhine-Westphalia, 42853, Germany
GSK Investigational Site
Siegen, North Rhine-Westphalia, 57072, Germany
GSK Investigational Site
Hamburg, 20249, Germany
GSK Investigational Site
Hamburg, 21149, Germany
GSK Investigational Site
Hamburg, 22083, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Athens, 115 21, Greece
GSK Investigational Site
Athens, 151 23, Greece
GSK Investigational Site
Melíssia, 151 27, Greece
GSK Investigational Site
Thessaloniki, 57010, Greece
GSK Investigational Site
Debrecen, 4043, Hungary
GSK Investigational Site
Győr, 9024, Hungary
GSK Investigational Site
Szeged, 6725, Hungary
GSK Investigational Site
Bangalore, 560 054, India
GSK Investigational Site
Bangalore, 560034, India
GSK Investigational Site
Hyderabad, 500 034, India
GSK Investigational Site
Mumbai, 400010, India
GSK Investigational Site
Nagpur, 440010, India
GSK Investigational Site
New Delhi, 110002, India
GSK Investigational Site
Pune, 411004, India
GSK Investigational Site
Varanasi, 221005, India
GSK Investigational Site
Chieti Scalo, Abruzzo, 66013, Italy
GSK Investigational Site
Bari, Apulia, 70124, Italy
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
San Felice A Cancello Caserta, Campania, 81027, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, 40138, Italy
GSK Investigational Site
Rome, Lazio, 00148, Italy
GSK Investigational Site
Rome, Lazio, 00163, Italy
GSK Investigational Site
Rome, Lazio, 00186, Italy
GSK Investigational Site
Brescia, Lombardy, 25123, Italy
GSK Investigational Site
Brescia, Lombardy, 25125, Italy
GSK Investigational Site
Milan, Lombardy, 20122, Italy
GSK Investigational Site
Milan, Lombardy, 20127, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Rho, Lombardy, 20017, Italy
GSK Investigational Site
Ancona, The Marches, 60020, Italy
GSK Investigational Site
Arezzo, Tuscany, 52100, Italy
GSK Investigational Site
Florence, Tuscany, 50134, Italy
GSK Investigational Site
Pisa, Tuscany, 56126, Italy
GSK Investigational Site
Verona, Veneto, 37100, Italy
GSK Investigational Site
Aichi, 451-0052, Japan
GSK Investigational Site
Aichi, 455-8530, Japan
GSK Investigational Site
Fukuoka, 813-8588, Japan
GSK Investigational Site
Fukuoka, 819-0165, Japan
GSK Investigational Site
Gunma, 375-0017, Japan
GSK Investigational Site
Hiroshima, 733-0864, Japan
GSK Investigational Site
Hokkaido, 005-0853, Japan
GSK Investigational Site
Hokkaido, 080-2470, Japan
GSK Investigational Site
Hyōgo, 672-8043, Japan
GSK Investigational Site
Ibaraki, 300-0053, Japan
GSK Investigational Site
Kagawa, 761-8024, Japan
GSK Investigational Site
Kanagawa, 231-0023, Japan
GSK Investigational Site
Kanagawa, 238-0042, Japan
GSK Investigational Site
Kochi, 780-0842, Japan
GSK Investigational Site
Kumamoto, 861-8002, Japan
GSK Investigational Site
Kyoto, 607-8062, Japan
GSK Investigational Site
Nagano, 399-8695, Japan
GSK Investigational Site
Osaka, 567-0011, Japan
GSK Investigational Site
Osaka, 569-1041, Japan
GSK Investigational Site
Tokyo, 193-0998, Japan
GSK Investigational Site
Saltillo, Coahuila, 25000, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64660, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64710, Mexico
GSK Investigational Site
México, 14000, Mexico
GSK Investigational Site
Bydgoszcz, 85-096, Poland
GSK Investigational Site
Katowice, 40-752, Poland
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Lodz, 91-348, Poland
GSK Investigational Site
Mosina, 62-050, Poland
GSK Investigational Site
Poznan, 61-298, Poland
GSK Investigational Site
Sopot, 81-824, Poland
GSK Investigational Site
Warsaw, 02-507, Poland
GSK Investigational Site
Coimbra, 3000-548, Portugal
GSK Investigational Site
Lisbon, 1649-035, Portugal
GSK Investigational Site
A Coruña, 15006, Spain
GSK Investigational Site
Burgos, 09006, Spain
GSK Investigational Site
Castellon, 12004, Spain
GSK Investigational Site
Elche (Alicante), 03202, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Girona, 17190, Spain
GSK Investigational Site
Granada, 18013, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Málaga, 29071, Spain
GSK Investigational Site
Murcia, 30120, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
San Sebastián, 20014, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Zurich, 8032, Switzerland
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
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- not applicable
- 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 6, 2006
Primary Completion
January 1, 2009
Study Completion
January 28, 2009
Last Updated
November 28, 2017
Results First Posted
November 28, 2017
Record last verified: 2017-09
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.