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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00490568




Registration number
NCT00490568
Ethics application status
Date submitted
21/06/2007
Date registered
22/06/2007
Date last updated
13/11/2017

Titles & IDs
Public title
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Scientific title
An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
Secondary ID [1] 0 0
AVA102675
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone XR

Experimental: Rosiglitazone XR - Investigational drug


Treatment: Drugs: Rosiglitazone XR
Experimental drug

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Events (AEs) and Severity of AEs - An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.
Timepoint [1] 0 0
Up to 76 Weeks
Secondary outcome [1] 0 0
Number Participants With Serious Adverse Events (SAEs) and Deaths - A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.
Timepoint [1] 0 0
Up to 76 Weeks
Secondary outcome [2] 0 0
Number of Participants With Adverse Event of Oedema - Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported.
Timepoint [2] 0 0
Up to 76 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) - Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.
Timepoint [3] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [4] 0 0
Change From Baseline in Vital Sign Heart Rate (HR) - Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.
Timepoint [4] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [5] 0 0
Change From Baseline in Vital Sign Body Weight (BW) - BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.
Timepoint [5] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [6] 0 0
Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides - The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.
Timepoint [6] 0 0
Up to 82 Weeks (including follow up)
Secondary outcome [7] 0 0
Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) - The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.
Timepoint [7] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [8] 0 0
Number of Participants With HR Values of PCC ATOT - HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported.
Timepoint [8] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [9] 0 0
Number of Participants With BW Values of PCC ATOT - The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported.
Timepoint [9] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [10] 0 0
Number of Participants With Hematology Parameters of PCC ATOT - The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.
Timepoint [10] 0 0
Up to Week 82 (including follow up)
Secondary outcome [11] 0 0
Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT - The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.
Timepoint [11] 0 0
Up to Week 82 (including follow up)
Secondary outcome [12] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) e4 Status. - 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 ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
Timepoint [12] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [13] 0 0
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE e4 Status. - The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (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, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
Timepoint [13] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [14] 0 0
Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE e4 Status. - The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
Timepoint [14] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [15] 0 0
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE e4 Status. - DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
Timepoint [15] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [16] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE e4 Status. - 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
Timepoint [16] 0 0
Baseline (Week 0) and Week 24, 52

Eligibility
Key inclusion criteria
Inclusion criteria:

- Successful completion of AVA102670 or AVA102672 without safety or tolerability issues.
Regular caregiver.
Minimum age
51 Years
Maximum age
91 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other
neurological conditions that might disqualify participation. SAE, clinically
significant laboratory abnormality or significant cardiovascular event during prior
study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Hornsby
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [4] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [7] 0 0
GSK Investigational Site - Cheltenham
Recruitment hospital [8] 0 0
GSK Investigational Site - Heidelberg Heights
Recruitment hospital [9] 0 0
GSK Investigational Site - Kew
Recruitment hospital [10] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3192 - Cheltenham
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg Heights
Recruitment postcode(s) [9] 0 0
3101 - Kew
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Córdova
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma de Buenos Aires
Country [25] 0 0
Austria
State/province [25] 0 0
Hall in Tirol
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Kortrijk
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Woluwe-Saint-Lambert
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Varna
Country [32] 0 0
Canada
State/province [32] 0 0
New Brunswick
Country [33] 0 0
Canada
State/province [33] 0 0
Nova Scotia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Prince Edward Island
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Canada
State/province [37] 0 0
Saskatchewan
Country [38] 0 0
Canada
State/province [38] 0 0
Québec
Country [39] 0 0
Chile
State/province [39] 0 0
Región Metro De Santiago
Country [40] 0 0
Chile
State/province [40] 0 0
Valparaíso
Country [41] 0 0
Czechia
State/province [41] 0 0
Olomouc
Country [42] 0 0
Czechia
State/province [42] 0 0
Ostrava
Country [43] 0 0
Czechia
State/province [43] 0 0
Praha 10
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 2
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 5
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 7
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 8
Country [48] 0 0
Czechia
State/province [48] 0 0
Trutnov
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
Finland
State/province [50] 0 0
Kuopio
Country [51] 0 0
France
State/province [51] 0 0
Bourg en Bresse
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France
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Caen
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France
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Dijon
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France
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Ivry
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France
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La Seyne sur Mer
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France
State/province [56] 0 0
Lille
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France
State/province [57] 0 0
Limoges
Country [58] 0 0
France
State/province [58] 0 0
Luynes
Country [59] 0 0
France
State/province [59] 0 0
Lyon
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France
State/province [60] 0 0
Marseille
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France
State/province [61] 0 0
Metz
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France
State/province [62] 0 0
Nantes
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France
State/province [63] 0 0
Nice
Country [64] 0 0
France
State/province [64] 0 0
Paris
Country [65] 0 0
France
State/province [65] 0 0
Pau
Country [66] 0 0
France
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Rodez
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France
State/province [67] 0 0
Saint Ouen la Rouerie
Country [68] 0 0
France
State/province [68] 0 0
Saint-Etienne
Country [69] 0 0
France
State/province [69] 0 0
Sautron
Country [70] 0 0
France
State/province [70] 0 0
Tinteniac
Country [71] 0 0
France
State/province [71] 0 0
Toulon
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France
State/province [72] 0 0
Toulouse
Country [73] 0 0
France
State/province [73] 0 0
Tours
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France
State/province [74] 0 0
Vichy
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Germany
State/province [75] 0 0
Baden-Wuerttemberg
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Germany
State/province [76] 0 0
Bayern
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Germany
State/province [77] 0 0
Brandenburg
Country [78] 0 0
Germany
State/province [78] 0 0
Hessen
Country [79] 0 0
Germany
State/province [79] 0 0
Mecklenburg-Vorpommern
Country [80] 0 0
Germany
State/province [80] 0 0
Niedersachsen
Country [81] 0 0
Germany
State/province [81] 0 0
Nordrhein-Westfalen
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Germany
State/province [82] 0 0
Sachsen
Country [83] 0 0
Germany
State/province [83] 0 0
Thueringen
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Hamburg
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Greece
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Athens
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Greece
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Melissia
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Greece
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Thessaloniki
Country [89] 0 0
Hong Kong
State/province [89] 0 0
Hong Kong
Country [90] 0 0
Hong Kong
State/province [90] 0 0
Shatin
Country [91] 0 0
Hungary
State/province [91] 0 0
Gyor
Country [92] 0 0
Hungary
State/province [92] 0 0
Szeged
Country [93] 0 0
India
State/province [93] 0 0
Hyderabad
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India
State/province [94] 0 0
Nagpur
Country [95] 0 0
India
State/province [95] 0 0
New Delhi
Country [96] 0 0
India
State/province [96] 0 0
Pune
Country [97] 0 0
India
State/province [97] 0 0
Varanasi
Country [98] 0 0
Italy
State/province [98] 0 0
Abruzzo
Country [99] 0 0
Italy
State/province [99] 0 0
Campania
Country [100] 0 0
Italy
State/province [100] 0 0
Lazio
Country [101] 0 0
Italy
State/province [101] 0 0
Lombardia
Country [102] 0 0
Italy
State/province [102] 0 0
Marche
Country [103] 0 0
Italy
State/province [103] 0 0
Toscana
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Seongnam-si,
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Seoul
Country [106] 0 0
Mexico
State/province [106] 0 0
Nuevo León
Country [107] 0 0
Mexico
State/province [107] 0 0
Mexico
Country [108] 0 0
Netherlands
State/province [108] 0 0
Alkmaar
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Netherlands
State/province [109] 0 0
Blaricum
Country [110] 0 0
Netherlands
State/province [110] 0 0
Den Bosch
Country [111] 0 0
Netherlands
State/province [111] 0 0
Den Haag
Country [112] 0 0
Netherlands
State/province [112] 0 0
Hengelo
Country [113] 0 0
Netherlands
State/province [113] 0 0
Hilversum
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Philippines
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Pasig City
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Poland
State/province [115] 0 0
Bydgoszcz
Country [116] 0 0
Poland
State/province [116] 0 0
Katowice
Country [117] 0 0
Poland
State/province [117] 0 0
Mosina
Country [118] 0 0
Poland
State/province [118] 0 0
Poznan
Country [119] 0 0
Poland
State/province [119] 0 0
Sopot
Country [120] 0 0
Poland
State/province [120] 0 0
Warsaw
Country [121] 0 0
Portugal
State/province [121] 0 0
Coimbra
Country [122] 0 0
Portugal
State/province [122] 0 0
Lisboa
Country [123] 0 0
Slovakia
State/province [123] 0 0
Bratislava
Country [124] 0 0
Slovakia
State/province [124] 0 0
Kosice
Country [125] 0 0
Slovenia
State/province [125] 0 0
Ljubljana
Country [126] 0 0
Slovenia
State/province [126] 0 0
Ĺ empeter
Country [127] 0 0
South Africa
State/province [127] 0 0
Loeventstein
Country [128] 0 0
South Africa
State/province [128] 0 0
Oakdale
Country [129] 0 0
South Africa
State/province [129] 0 0
Richards Bay
Country [130] 0 0
South Africa
State/province [130] 0 0
Rosebank
Country [131] 0 0
South Africa
State/province [131] 0 0
Somerset West
Country [132] 0 0
South Africa
State/province [132] 0 0
Waverley, Bloemfontein
Country [133] 0 0
South Africa
State/province [133] 0 0
Willows, X14, Pretoria
Country [134] 0 0
Spain
State/province [134] 0 0
Barcelona
Country [135] 0 0
Spain
State/province [135] 0 0
Burgos
Country [136] 0 0
Spain
State/province [136] 0 0
Castellón
Country [137] 0 0
Spain
State/province [137] 0 0
Elche (Alicante)
Country [138] 0 0
Spain
State/province [138] 0 0
Gerona
Country [139] 0 0
Spain
State/province [139] 0 0
Madrid
Country [140] 0 0
Spain
State/province [140] 0 0
Murcia
Country [141] 0 0
Spain
State/province [141] 0 0
Palma de Mallorca
Country [142] 0 0
Spain
State/province [142] 0 0
Tarrasa, Barcelona
Country [143] 0 0
Spain
State/province [143] 0 0
Valencia
Country [144] 0 0
Sweden
State/province [144] 0 0
Jönköping
Country [145] 0 0
Sweden
State/province [145] 0 0
Kalix
Country [146] 0 0
Sweden
State/province [146] 0 0
Mölndal
Country [147] 0 0
Sweden
State/province [147] 0 0
Sundsvall
Country [148] 0 0
Sweden
State/province [148] 0 0
Umeå
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Lancashire
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Bradford
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Liverpool
Country [152] 0 0
United Kingdom
State/province [152] 0 0
West of Scotland Science Park, Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase III, multicenter, open-label extension, single-group study in male and female
outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either
AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg
once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to
their existing dose of acetylcholinesterase inhibitor. Subject participation will last until
one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend
a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this
study is to evaluate the long-term safety and tolerability of RSG XR in subjects with
mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective
of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive
function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele
status.
Trial website
https://clinicaltrials.gov/show/NCT00490568
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00490568