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Trial record 6 of 15 for:    Alzheimer rosiglitazone

Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

This study has been terminated.
(Based on preliminary parent study results)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490568
First Posted: June 22, 2007
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: Rosiglitazone XR Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Any Adverse Events (AEs) and Severity of AEs [ Time Frame: Up to 76 Weeks ]
    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.


Secondary Outcome Measures:
  • Number Participants With Serious Adverse Events (SAEs) and Deaths [ Time Frame: Up to 76 Weeks ]
    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.

  • Number of Participants With Adverse Event of Oedema [ Time Frame: Up to 76 Weeks ]
    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.

  • Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Up to 70 Weeks (including follow up) ]
    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.

  • Change From Baseline in Vital Sign Heart Rate (HR) [ Time Frame: Up to 70 Weeks (including follow up) ]
    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.

  • Change From Baseline in Vital Sign Body Weight (BW) [ Time Frame: Up to 70 Weeks (including follow up) ]
    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.

  • Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides [ Time Frame: Up to 82 Weeks (including follow up) ]
    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.

  • Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) [ Time Frame: Up to 70 Weeks (including follow up) ]
    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.

  • Number of Participants With HR Values of PCC ATOT [ Time Frame: Up to 70 Weeks (including follow up) ]
    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.

  • Number of Participants With BW Values of PCC ATOT [ Time Frame: Up to 70 Weeks (including follow up) ]
    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.

  • Number of Participants With Hematology Parameters of PCC ATOT [ Time Frame: Up to Week 82 (including follow up) ]
    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.

  • Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT [ Time Frame: Up to Week 82 (including follow up) ]
    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.

  • Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status. [ Time Frame: Baseline (Week 0) and Week 24, 52 ]
    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.

  • Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status. [ Time Frame: Baseline (Week 0) and Week 24, 52 ]
    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.

  • Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status. [ Time Frame: Baseline (Week 0) and Week 24, 52 ]
    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.

  • Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status. [ Time Frame: Baseline (Week 0) and Week 24, 52 ]
    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.

  • Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status. [ Time Frame: Baseline (Week 0) and Week 24, 52 ]
    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.


Enrollment: 1461
Actual Study Start Date: August 8, 2007
Study Completion Date: June 1, 2009
Primary Completion Date: June 1, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosiglitazone XR
Investigational drug
Drug: Rosiglitazone XR
Experimental drug

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   51 Years to 91 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490568


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Locations
United States, Arizona
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
GSK Investigational Site
Phoenix, Arizona, United States, 85013
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Tucson, Arizona, United States, 85741
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Fresno, California, United States, 93720
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Rancho Mirage, California, United States, 92270
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Sacramento, California, United States, 95816
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San Diego, California, United States, 92103
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San Francisco, California, United States, 94109
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Sherman Oaks, California, United States, 91403
United States, Connecticut
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New Haven, Connecticut, United States, 06510
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Norwalk, Connecticut, United States, 06851
United States, Florida
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Deerfield Beach, Florida, United States, 33064
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Delray Beach, Florida, United States, 33445
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Hialeah, Florida, United States, 33016
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Ocala, Florida, United States, 34471
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Saint Petersburg, Florida, United States, 33702
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West Palm Beach, Florida, United States, 33407
United States, Indiana
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Fort Wayne, Indiana, United States, 46805
United States, Maryland
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Rockville, Maryland, United States, 20852
United States, Massachusetts
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Springfield, Massachusetts, United States, 01104
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West Yarmouth, Massachusetts, United States, 02673
United States, Minnesota
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Saint Paul, Minnesota, United States, 55101
United States, New Jersey
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Morristown, New Jersey, United States, 07960
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Stratford, New Jersey, United States, 08084
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Toms River, New Jersey, United States, 08755
United States, New York
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Albany, New York, United States, 12205
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Brooklyn, New York, United States, 11235
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New York, New York, United States, 10016
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Syracuse, New York, United States, 13210
United States, North Carolina
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Columbus, Ohio, United States, 43210
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Toledo, Ohio, United States, 43623
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Tulsa, Oklahoma, United States, 74104
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Pittsburgh, Pennsylvania, United States, 15213
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Providence, Rhode Island, United States, 02906
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Austin, Texas, United States, 78757
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South Ogden, Utah, United States, 84403
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Bennington, Vermont, United States, 05201
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Argentina
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1192AAW
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1419HDN
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
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Cordoba, Córdova, Argentina, 5000
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Córdoba, Córdova, Argentina, X5004AOA
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Córdoba, Córdova, Argentina, x5009bin
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Godoy Cruz, Mendoza, Argentina, M5504FMI
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Ciudad Autonoma de Buenos Aires, Argentina, C1425CDC
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Mendoza, Argentina, CPM5500HIF
Australia, New South Wales
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Hornsby, New South Wales, Australia, 2077
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Randwick, New South Wales, Australia, 2031
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
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Chermside, Queensland, Australia, 4032
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Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
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Woodville, South Australia, Australia, 5011
Australia, Victoria
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Cheltenham, Victoria, Australia, 3192
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Heidelberg Heights, Victoria, Australia, 3084
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Kew, Victoria, Australia, 3101
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Austria
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Hall in Tirol, Austria, A-6060
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Vienna, Austria, 1010
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Vienna, Austria, 1030
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Vienna, Austria, A-1130
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Vienna, Austria, A-1220
Belgium
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Woluwe-Saint-Lambert, Belgium, 1200
Bulgaria
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Sofia, Bulgaria, 1113
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1527
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Varna, Bulgaria, 9010
Canada, New Brunswick
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Saint John, New Brunswick, Canada, E2L 3L6
Canada, Nova Scotia
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Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
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Kingston, Ontario, Canada, K7L 4X3
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Kingston, Ontario, Canada, K7L 5G2
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Ottawa, Ontario, Canada, K1G 4G3
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Ottawa, Ontario, Canada, K1N 5C8
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Peterborough, Ontario, Canada, K9H 2P4
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Toronto, Ontario, Canada, M3B 2S7
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Toronto, Ontario, Canada, M5T 2S8
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Toronto, Ontario, Canada, M6M 3Z5
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Whitby, Ontario, Canada, L1N 5S9
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 5Y8
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H4H 1R3
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Sherbrooke, Quebec, Canada, J1H 1Z1
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Sherbrooke, Quebec, Canada, J1J 3H5
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4T 1A5
Canada
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Québec, Canada, G1R 3X5
Chile
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Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
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Santiago, Región Metro De Santiago, Chile, 7560356
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Viña del Mar, Valparaíso, Chile, 252-0997
Czechia
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Olomouc, Czechia, 775 20
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Ostrava, Czechia, 702 00
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Praha 10, Czechia, 10000
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Praha 2, Czechia, 120 00
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Praha 5, Czechia, 150 18
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Praha 7, Czechia, 170 00
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Praha 8, Czechia, 180 00
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Trutnov, Czechia, 541 01
Finland
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Helsinki, Finland, 00120
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Kuopio, Finland, 70211
France
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Bourg en Bresse, France, 01012
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Caen, France, 14033
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Dijon, France, 21000
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Ivry, France, 94206
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La Seyne sur Mer, France, 83500
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Lille, France, 59000
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Limoges, France, 87042
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Luynes, France, 37230
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Lyon, France, 69006
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Marseille, France, 13008
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Marseille, France, 13009
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Metz, France, 57038
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Nantes, France, 44000
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Nantes, France, 44093
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Nantes, France, 44200
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Nantes, France, 44300
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Nice, France, 06002
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Paris, France, 75013
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Pau, France, 64000
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Rodez, France, 12000
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Saint Ouen la Rouerie, France, 35460
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Saint-Etienne, France, 42100
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Sautron, France, 44880
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Tinteniac, France, 35190
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Toulon, France, 83000
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Toulouse, France, 31300
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Tours, France, 37100
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Vichy, France, 03200
Germany
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Aalen, Baden-Wuerttemberg, Germany, 73430
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Ellwangen, Baden-Wuerttemberg, Germany, 73479
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Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
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Ostfildern, Baden-Wuerttemberg, Germany, 73760
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Stuttgart, Baden-Wuerttemberg, Germany, 70176
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
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Ulm, Baden-Wuerttemberg, Germany, 89075
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Alzenau, Bayern, Germany, 63755
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Muenchen, Bayern, Germany, 80331
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Muenchen, Bayern, Germany, 80333
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Muenchen, Bayern, Germany, 81667
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Muenchen, Bayern, Germany, 81675
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Nuernberg, Bayern, Germany, 90402
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Regensburg, Bayern, Germany, 93053
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Unterhaching, Bayern, Germany, 82008
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Bad Saarow, Brandenburg, Germany, 15526
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Bad Homburg, Hessen, Germany, 61348
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Erbach, Hessen, Germany, 64711
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Schwerin, Mecklenburg-Vorpommern, Germany, 19053
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Achim, Niedersachsen, Germany, 28832
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Bockhorn, Niedersachsen, Germany, 26345
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Ganderkesee, Niedersachsen, Germany, 27777
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Goettingen, Niedersachsen, Germany, 37075
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Hannover, Niedersachsen, Germany, 30559
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Lueneburg, Niedersachsen, Germany, 21335
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Westerstede, Niedersachsen, Germany, 26655
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Bad Honnef, Nordrhein-Westfalen, Germany, 53604
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Baesweiler, Nordrhein-Westfalen, Germany, 52499
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Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51465
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Bochum, Nordrhein-Westfalen, Germany, 44791
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Bochum, Nordrhein-Westfalen, Germany, 44805
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Bochum, Nordrhein-Westfalen, Germany, 44869
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Dueren, Nordrhein-Westfalen, Germany, 52349
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Duisburg, Nordrhein-Westfalen, Germany, 47051
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Essen, Nordrhein-Westfalen, Germany, 45138
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Hattingen, Nordrhein-Westfalen, Germany, 45525
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Juelich, Nordrhein-Westfalen, Germany, 52428
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Koeln, Nordrhein-Westfalen, Germany, 50767
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Krefeld, Nordrhein-Westfalen, Germany, 47800
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Siegen, Nordrhein-Westfalen, Germany, 57072
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Chemnitz, Sachsen, Germany, 09111
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Dresden, Sachsen, Germany, 01097
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Dresden, Sachsen, Germany, 01307
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Leipzig, Sachsen, Germany, 04107
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Leipzig, Sachsen, Germany, 04157
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Gera, Thueringen, Germany, 07551
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Jena, Thueringen, Germany, 07743
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Berlin, Germany, 12163
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Berlin, Germany, 12167
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Berlin, Germany, 12555
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Berlin, Germany, 13156
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Berlin, Germany, 13357
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Berlin, Germany, 13439
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Hamburg, Germany, 21149
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Hamburg, Germany, 22083
Greece
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Athens, Greece, 115 21
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Athens, Greece, 151 23
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Melissia, Greece, 151 27
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Thessaloniki, Greece, 57010
Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
Hungary
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Győr, Hungary, 9024
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Szeged, Hungary, 6725
India
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Hyderabad, India, 500 034
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Nagpur, India, 440010
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New Delhi, India, 110002
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Pune, India, 411004
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Varanasi, India, 221005
Italy
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Chieti Scalo, Abruzzo, Italy, 66013
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Napoli, Campania, Italy, 80131
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San Felice a Cancello Caserta, Campania, Italy, 81027
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Roma, Lazio, Italy, 00148
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Roma, Lazio, Italy, 00163
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Roma, Lazio, Italy, 00186
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Brescia, Lombardia, Italy, 25125
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Milano, Lombardia, Italy, 20122
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Milano, Lombardia, Italy, 20127
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Pavia, Lombardia, Italy, 27100
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Rho, Lombardia, Italy, 20017
GSK Investigational Site
Torrette (AN), Marche, Italy, 60020
GSK Investigational Site
Arezzo, Toscana, Italy, 52100
GSK Investigational Site
Firenze, Toscana, Italy, 50134
GSK Investigational Site
Pisa, Toscana, Italy, 56126
Korea, Republic of
GSK Investigational Site
Seongnam-si,, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 150-713
Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64660
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64710
GSK Investigational Site
Mexico, Mexico, 14000
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Blaricum, Netherlands, 1261 AN
GSK Investigational Site
Den Bosch, Netherlands, 5232 JL
GSK Investigational Site
Den Haag, Netherlands, 2545 CH
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Hilversum, Netherlands, 1213 XZ
Philippines
GSK Investigational Site
Pasig City, Philippines, 1600
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-096
GSK Investigational Site
Bydgoszcz, Poland, 85-796
GSK Investigational Site
Katowice, Poland, 40-752
GSK Investigational Site
Mosina, Poland, 62-050
GSK Investigational Site
Poznan, Poland, 61-298
GSK Investigational Site
Sopot, Poland, 81-824
GSK Investigational Site
Warsaw, Poland, 02-097
Portugal
GSK Investigational Site
Coimbra, Portugal, 3000-548
GSK Investigational Site
Lisboa, Portugal, 1649-035
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 811 01
GSK Investigational Site
Bratislava, Slovakia, 811 07
GSK Investigational Site
Bratislava, Slovakia, 825 56
GSK Investigational Site
Kosice, Slovakia, 041 66
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
Šempeter, Slovenia, 5290
South Africa
GSK Investigational Site
Loeventstein, South Africa, 7530
GSK Investigational Site
Oakdale, South Africa, 7530
GSK Investigational Site
Richards Bay, South Africa, 3900
GSK Investigational Site
Rosebank, South Africa, 2196
GSK Investigational Site
Somerset West, South Africa, 7130
GSK Investigational Site
Waverley, Bloemfontein, South Africa, 9301
GSK Investigational Site
Willows, X14, Pretoria, South Africa, 0040
Spain
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08014
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08907
GSK Investigational Site
Burgos, Spain, 09006
GSK Investigational Site
Castellón, Spain, 12004
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Gerona, Spain, 17190
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Murcia, Spain, 30120
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
GSK Investigational Site
Valencia, Spain, 46010
Sweden
GSK Investigational Site
Jönköping, Sweden, SE-551 85
GSK Investigational Site
Kalix, Sweden, SE-952 82
GSK Investigational Site
Mölndal, Sweden, SE-431 41
GSK Investigational Site
Sundsvall, Sweden, SE-851 86
GSK Investigational Site
Umeå, Sweden, SE-901 85
United Kingdom
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY2 0JH
GSK Investigational Site
Bradford, United Kingdom, BD3 0DQ
GSK Investigational Site
Liverpool, United Kingdom, L9 7LJ
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00490568     History of Changes
Other Study ID Numbers: AVA102675
First Submitted: June 21, 2007
First Posted: June 22, 2007
Results First Submitted: September 5, 2017
Results First Posted: November 10, 2017
Last Update Posted: November 10, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
cognition
Alzheimer's disease
Rosiglitazone extended-release (XR)
safety
adjunctive therapy
BRL-049653
tolerability
open-label extension

Additional relevant MeSH terms:
Alzheimer Disease
Rosiglitazone
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs