Clinical trial NCT00348140: Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: adjunctive therapy
moderate
Alzheimer's disease
apolipoprotein E
mild
rosiglitazone
cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 1468
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A 54-week, double-blind, randomized, 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 APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-3)

Eligibility criteria: Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

* 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.

(Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)

* Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
* Subjects considered for enrolment must have a QTc (either QTc B (Bazett's correction) or QTc F (Fridericia's correction)) \<450msec at Visit 1, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be \<480msec).

(Note: For the purposes of these criteria, QTc B is defined as (QT interval \[msec\]) / (square root of RR interval \[seconds\]); and QTc F is defined as (QT interval \[msec\]) / (cube root of RR interval \[seconds\]).)

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* 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.)

* History or presence of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
* 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.
* Clinically significant anemia (i.e. hemoglobin \<11 g/dL for males or \<10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA1c.
* Abnormal kidney function tests (\>1.5 times the upper limit of normal (ULN)).
* ALT, AST, or alkaline phosphatase values \>2.5 times the ULN, total bilirubin values \>1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C).

(Note: For subjects with a diagnosis of Gilberts Syndrome and an isolated increase in total bilirubin \>1.5 ULN, fractionation should be performed. If all of the following conditions are met, the patient may enter or remain in the study, even if total bilirubin \>1.5 ULN:

* an elevated unconjugated (indirect) bilirubin;
* the percentage of direct bilirubin \<35%;
* ALT, AST, and alkaline phosphatase \<2.5 ULN if subject is in screening (\<2.0 ULN for Canadian subjects only), or ≤3 ULN if subject is already randomized into the study)
* History of a bone marrow transplant.
* Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study or is at risk of non-compliance with study medication or procedures.
* Subject is an immediate family member or employee of the participating Investigator, of any of the participating site staff, or of GSK.
* In France, a subject is neither affiliated with nor a beneficiary of a social security category.
* The French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).
* Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Screening, as well as for the duration of the study.

Primary outcomes:
measure: 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
timeFrame: Baseline (Week 0) and Week 48
measure: Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort
timeFrame: Baseline (Week 0) and Week 48
measure: Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort
timeFrame: Baseline (Week 0) and Week 48
measure: 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
timeFrame: Baseline (Week 0) and Week 48
measure: Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort
timeFrame: Baseline (Week 0) and Week 48
measure: Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort
timeFrame: Baseline (Week 0) and Week 48
Secondary outcomes:
measure: Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36
timeFrame: Baseline (Week 0) and Week 8, 16, 24, 36
measure: Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36
timeFrame: Baseline (Week 0) and Week 12, 24, 36
measure: Change From Screening in Mini Mental State Examination (MMSE) Total Score
timeFrame: Screening (Week -4) and Week 48
measure: Change From Baseline in Disability Assessment for Dementia (DAD) Total Score
timeFrame: Baseline (Week 0) and Week 8, 16, 24, 48
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
timeFrame: Baseline (Week 0) and Week 8, 16, 24, 48
measure: Change From Baseline in Domains of the Resource Utilization in Dementia Scale (RUD)- Q1 and Q2 Caregiver Hours
timeFrame: Baseline (Week 0) and Week 12, 24, 36, 48
measure: Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Scale Total Score- Thermometer Score
timeFrame: Baseline (Week 0) and Week 12, 36, 48
measure: Change From Baseline in EQ-5D Scale Total Score- Utility Score
timeFrame: Baseline (Week 0) and Week 12, 36, 48
measure: Change From Baseline in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score
timeFrame: Baseline (Week 0) and Week 12, 36, 48
measure: Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48
timeFrame: Week 48 and Week 54
measure: Change in CDR-SB Total Score for Observed Cases at Week 54 Compared to Week 48
timeFrame: Week 48 and Week 54
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48
timeFrame: Baseline (Week 0) and Week 48
measure: Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Severity of AEs
timeFrame: Upto Week 48
measure: Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Weight
timeFrame: Upto Week 54
measure: Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Upto Week 54
measure: Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Heart Rate (HR)
timeFrame: Upto Week 54
measure: Change From Baseline in Weight
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 24, 36, 48, 54
measure: Change From Baseline in Hemoglobin
timeFrame: Baseline (Week 0) and Weeks 4, 16, 36, 48
measure: Change From Baseline in Hematocrit
timeFrame: Baseline (Week 0) and Weeks 4, 16, 36, 48
measure: Any Time on Treatment Differences in Frequencies of Hematology Data Outside the Reference Range
timeFrame: Up to Week 48
measure: Any Time on Treatment Differences in Frequencies of Clinical Chemistry Data Outside the Reference Range
timeFrame: Upto Week 48
measure: Changes From Baseline in Electrocardiogram (ECG) Parameters- HR
timeFrame: Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54
measure: Changes From Baseline in ECG Parameters- RR Interval, QT Interval, QTcB, QTcF, PR Interval and QRS Duration
timeFrame: Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54
measure: Change From Baseline in HbA1c up to Week 54
timeFrame: Baseline (Week 0) and Weeks 12, 24, 36, 48, 54
measure: Change From Baseline in Short Term Memory Assessment
timeFrame: Baseline (Week 0) and upto Week 48
Other outcomes:
Locations:
city: Sun City
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Laguna Hills
country: United States
facility: GSK Investigational Site
state: California
city: Redlands
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Norwalk
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Deerfield Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Ocala
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Springfield
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: West Yarmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Eatontown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Manchester Township
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Amherst
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Centerville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Jenkintown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Middleton
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Hornsby
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Chermside
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Cheltenham
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg West
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Kew
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Woluwe-Saint-Lambert
country: Belgium
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Saint John
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Kentville
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Praha 10
country: Czechia
facility: GSK Investigational Site
city: Praha 8
country: Czechia
facility: GSK Investigational Site
city: Trutnov
country: Czechia
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Joensuu
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Bordeaux
country: France
facility: GSK Investigational Site
city: La Chapelle sur Erdre
country: France
facility: GSK Investigational Site
city: La Seyne sur Mer
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Limoges
country: France
facility: GSK Investigational Site
city: Metz
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Sautron
country: France
facility: GSK Investigational Site
city: Toulon
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Valence
country: France
facility: GSK Investigational Site
city: Aalen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Calw
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ellwangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ludwigsburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wiesloch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Alzenau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Unterhaching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bad Saarow
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Bad Homburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Erbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Gera
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Seongnam-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Bandar Tun Razak, Cheras
country: Malaysia
facility: GSK Investigational Site
city: Bandar Tun Razak, Cheras
country: Malaysia
facility: GSK Investigational Site
city: Ipoh
country: Malaysia
facility: GSK Investigational Site
city: Kelantan
country: Malaysia
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Blaricum
country: Netherlands
facility: GSK Investigational Site
city: Den Bosch
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Hilversum
country: Netherlands
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Pasig City
country: Philippines
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Ljubljana
country: Slovenia
facility: GSK Investigational Site
city: Šempeter
country: Slovenia
facility: GSK Investigational Site
city: Loeventstein
country: South Africa
facility: GSK Investigational Site
city: Oakdale
country: South Africa
facility: GSK Investigational Site
city: Richards Bay
country: South Africa
facility: GSK Investigational Site
city: Rosebank
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Waverley, Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Willows, X14, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Baracaldo/Vizcaya
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Tarrasa, Barcelona
country: Spain
facility: GSK Investigational Site
city: Falköping
country: Sweden
facility: GSK Investigational Site
city: Jönköping
country: Sweden
facility: GSK Investigational Site
city: Kalix
country: Sweden
facility: GSK Investigational Site
city: Mölndal
country: Sweden
facility: GSK Investigational Site
city: Sundsvall
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Bradford
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Stirling
country: United Kingdom
facility: GSK Investigational Site
city: West End, Southampton
country: United Kingdom
facility: GSK Investigational Site
city: West of Scotland Science Park, Glasgow
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.