Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosiglitazone XR
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring cognition, Alzheimer's disease, Rosiglitazone extended-release (XR), safety, adjunctive therapy, BRL-049653, tolerability, open-label extension
Eligibility 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rosiglitazone XR
Arm Description
Investigational drug
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 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.
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 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.
Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 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.
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 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.
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00490568
Brief Title
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Based on preliminary parent study results
Study Start Date
August 8, 2007 (Actual)
Primary Completion Date
June 1, 2009 (Actual)
Study Completion Date
June 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
cognition, Alzheimer's disease, Rosiglitazone extended-release (XR), safety, adjunctive therapy, BRL-049653, tolerability, open-label extension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosiglitazone XR
Arm Type
Experimental
Arm Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone XR
Intervention Description
Experimental drug
Primary Outcome Measure Information:
Title
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
Description
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.
Time Frame
Up to 76 Weeks
Secondary Outcome Measure Information:
Title
Number Participants With Serious Adverse Events (SAEs) and Deaths
Description
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.
Time Frame
Up to 76 Weeks
Title
Number of Participants With Adverse Event of Oedema
Description
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.
Time Frame
Up to 76 Weeks
Title
Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description
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.
Time Frame
Up to 70 Weeks (including follow up)
Title
Change From Baseline in Vital Sign Heart Rate (HR)
Description
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.
Time Frame
Up to 70 Weeks (including follow up)
Title
Change From Baseline in Vital Sign Body Weight (BW)
Description
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.
Time Frame
Up to 70 Weeks (including follow up)
Title
Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides
Description
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.
Time Frame
Up to 82 Weeks (including follow up)
Title
Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)
Description
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.
Time Frame
Up to 70 Weeks (including follow up)
Title
Number of Participants With HR Values of PCC ATOT
Description
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.
Time Frame
Up to 70 Weeks (including follow up)
Title
Number of Participants With BW Values of PCC ATOT
Description
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.
Time Frame
Up to 70 Weeks (including follow up)
Title
Number of Participants With Hematology Parameters of PCC ATOT
Description
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.
Time Frame
Up to Week 82 (including follow up)
Title
Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT
Description
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.
Time Frame
Up to Week 82 (including follow up)
Title
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.
Description
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.
Time Frame
Baseline (Week 0) and Week 24, 52
Title
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.
Description
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.
Time Frame
Baseline (Week 0) and Week 24, 52
Title
Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.
Description
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.
Time Frame
Baseline (Week 0) and Week 24, 52
Title
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.
Description
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.
Time Frame
Baseline (Week 0) and Week 24, 52
Title
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.
Description
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.
Time Frame
Baseline (Week 0) and Week 24, 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
GSK Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
GSK Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
GSK Investigational Site
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
GSK Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
GSK Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
GSK Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
GSK Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
GSK Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
GSK Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
GSK Investigational Site
City
West Yarmouth
State/Province
Massachusetts
ZIP/Postal Code
02673
Country
United States
Facility Name
GSK Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
GSK Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
GSK Investigational Site
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
GSK Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
GSK Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
GSK Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
GSK Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
GSK Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
GSK Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
GSK Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
GSK Investigational Site
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
GSK Investigational Site
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1192AAW
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1419HDN
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
State/Province
Córdova
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Córdoba
State/Province
Córdova
ZIP/Postal Code
X5004AOA
Country
Argentina
Facility Name
GSK Investigational Site
City
Córdoba
State/Province
Córdova
ZIP/Postal Code
x5009bin
Country
Argentina
Facility Name
GSK Investigational Site
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
M5504FMI
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1425CDC
Country
Argentina
Facility Name
GSK Investigational Site
City
Mendoza
ZIP/Postal Code
CPM5500HIF
Country
Argentina
Facility Name
GSK Investigational Site
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
GSK Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
GSK Investigational Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
GSK Investigational Site
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
GSK Investigational Site
City
Cheltenham
State/Province
Victoria
ZIP/Postal Code
3192
Country
Australia
Facility Name
GSK Investigational Site
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
GSK Investigational Site
City
Kew
State/Province
Victoria
ZIP/Postal Code
3101
Country
Australia
Facility Name
GSK Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
GSK Investigational Site
City
Hall in Tirol
ZIP/Postal Code
A-6060
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
1010
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
GSK Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Woluwe-Saint-Lambert
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3L6
Country
Canada
Facility Name
GSK Investigational Site
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
GSK Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
Facility Name
GSK Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
GSK Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 3Z5
Country
Canada
Facility Name
GSK Investigational Site
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 5S9
Country
Canada
Facility Name
GSK Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 5Y8
Country
Canada
Facility Name
GSK Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 3H5
Country
Canada
Facility Name
GSK Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
ZIP/Postal Code
G1R 3X5
Country
Canada
Facility Name
GSK Investigational Site
City
Providencia / Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
GSK Investigational Site
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
252-0997
Country
Chile
Facility Name
GSK Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 18
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Trutnov
ZIP/Postal Code
541 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00120
Country
Finland
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
GSK Investigational Site
City
Bourg en Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
GSK Investigational Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
GSK Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
GSK Investigational Site
City
Ivry
ZIP/Postal Code
94206
Country
France
Facility Name
GSK Investigational Site
City
La Seyne sur Mer
ZIP/Postal Code
83500
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
GSK Investigational Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
GSK Investigational Site
City
Luynes
ZIP/Postal Code
37230
Country
France
Facility Name
GSK Investigational Site
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
GSK Investigational Site
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
GSK Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
GSK Investigational Site
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
GSK Investigational Site
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
GSK Investigational Site
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
GSK Investigational Site
City
Rodez
ZIP/Postal Code
12000
Country
France
Facility Name
GSK Investigational Site
City
Saint Ouen la Rouerie
ZIP/Postal Code
35460
Country
France
Facility Name
GSK Investigational Site
City
Saint-Etienne
ZIP/Postal Code
42100
Country
France
Facility Name
GSK Investigational Site
City
Sautron
ZIP/Postal Code
44880
Country
France
Facility Name
GSK Investigational Site
City
Tinteniac
ZIP/Postal Code
35190
Country
France
Facility Name
GSK Investigational Site
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
GSK Investigational Site
City
Tours
ZIP/Postal Code
37100
Country
France
Facility Name
GSK Investigational Site
City
Vichy
ZIP/Postal Code
03200
Country
France
Facility Name
GSK Investigational Site
City
Aalen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73430
Country
Germany
Facility Name
GSK Investigational Site
City
Ellwangen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73479
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigsburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71634
Country
Germany
Facility Name
GSK Investigational Site
City
Ostfildern
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73760
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70176
Country
Germany
Facility Name
GSK Investigational Site
City
Tuebingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
GSK Investigational Site
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
GSK Investigational Site
City
Alzenau
State/Province
Bayern
ZIP/Postal Code
63755
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80331
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80333
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81667
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90402
Country
Germany
Facility Name
GSK Investigational Site
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
GSK Investigational Site
City
Unterhaching
State/Province
Bayern
ZIP/Postal Code
82008
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Saarow
State/Province
Brandenburg
ZIP/Postal Code
15526
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Homburg
State/Province
Hessen
ZIP/Postal Code
61348
Country
Germany
Facility Name
GSK Investigational Site
City
Erbach
State/Province
Hessen
ZIP/Postal Code
64711
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19053
Country
Germany
Facility Name
GSK Investigational Site
City
Achim
State/Province
Niedersachsen
ZIP/Postal Code
28832
Country
Germany
Facility Name
GSK Investigational Site
City
Bockhorn
State/Province
Niedersachsen
ZIP/Postal Code
26345
Country
Germany
Facility Name
GSK Investigational Site
City
Ganderkesee
State/Province
Niedersachsen
ZIP/Postal Code
27777
Country
Germany
Facility Name
GSK Investigational Site
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30559
Country
Germany
Facility Name
GSK Investigational Site
City
Lueneburg
State/Province
Niedersachsen
ZIP/Postal Code
21335
Country
Germany
Facility Name
GSK Investigational Site
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Honnef
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53604
Country
Germany
Facility Name
GSK Investigational Site
City
Baesweiler
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52499
Country
Germany
Facility Name
GSK Investigational Site
City
Bergisch Gladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51465
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44805
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44869
Country
Germany
Facility Name
GSK Investigational Site
City
Dueren
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52349
Country
Germany
Facility Name
GSK Investigational Site
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47051
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45138
Country
Germany
Facility Name
GSK Investigational Site
City
Hattingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45525
Country
Germany
Facility Name
GSK Investigational Site
City
Juelich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52428
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50767
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47800
Country
Germany
Facility Name
GSK Investigational Site
City
Siegen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
57072
Country
Germany
Facility Name
GSK Investigational Site
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09111
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01097
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04107
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04157
Country
Germany
Facility Name
GSK Investigational Site
City
Gera
State/Province
Thueringen
ZIP/Postal Code
07551
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07743
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12167
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12555
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13357
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13439
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
21149
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22083
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 21
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
151 23
Country
Greece
Facility Name
GSK Investigational Site
City
Melissia
ZIP/Postal Code
151 27
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
GSK Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
GSK Investigational Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
GSK Investigational Site
City
Hyderabad
ZIP/Postal Code
500 034
Country
India
Facility Name
GSK Investigational Site
City
Nagpur
ZIP/Postal Code
440010
Country
India
Facility Name
GSK Investigational Site
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
GSK Investigational Site
City
Varanasi
ZIP/Postal Code
221005
Country
India
Facility Name
GSK Investigational Site
City
Chieti Scalo
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
San Felice a Cancello Caserta
State/Province
Campania
ZIP/Postal Code
81027
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00148
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00163
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00186
Country
Italy
Facility Name
GSK Investigational Site
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
GSK Investigational Site
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
GSK Investigational Site
City
Rho
State/Province
Lombardia
ZIP/Postal Code
20017
Country
Italy
Facility Name
GSK Investigational Site
City
Torrette (AN)
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
GSK Investigational Site
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
GSK Investigational Site
City
Seongnam-si,
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64660
Country
Mexico
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
GSK Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Bosch
ZIP/Postal Code
5232 JL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-096
Country
Poland
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
GSK Investigational Site
City
Mosina
ZIP/Postal Code
62-050
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-298
Country
Poland
Facility Name
GSK Investigational Site
City
Sopot
ZIP/Postal Code
81-824
Country
Poland
Facility Name
GSK Investigational Site
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
GSK Investigational Site
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
811 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
811 07
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
825 56
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
041 66
Country
Slovakia
Facility Name
GSK Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Šempeter
ZIP/Postal Code
5290
Country
Slovenia
Facility Name
GSK Investigational Site
City
Loeventstein
ZIP/Postal Code
7530
Country
South Africa
Facility Name
GSK Investigational Site
City
Oakdale
ZIP/Postal Code
7530
Country
South Africa
Facility Name
GSK Investigational Site
City
Richards Bay
ZIP/Postal Code
3900
Country
South Africa
Facility Name
GSK Investigational Site
City
Rosebank
ZIP/Postal Code
2196
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
GSK Investigational Site
City
Waverley, Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
GSK Investigational Site
City
Willows, X14, Pretoria
ZIP/Postal Code
0040
Country
South Africa
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
GSK Investigational Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
GSK Investigational Site
City
Castellón
ZIP/Postal Code
12004
Country
Spain
Facility Name
GSK Investigational Site
City
Elche (Alicante)
ZIP/Postal Code
03202
Country
Spain
Facility Name
GSK Investigational Site
City
Gerona
ZIP/Postal Code
17190
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
GSK Investigational Site
City
Tarrasa, Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
GSK Investigational Site
City
Jönköping
ZIP/Postal Code
SE-551 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Kalix
ZIP/Postal Code
SE-952 82
Country
Sweden
Facility Name
GSK Investigational Site
City
Mölndal
ZIP/Postal Code
SE-431 41
Country
Sweden
Facility Name
GSK Investigational Site
City
Sundsvall
ZIP/Postal Code
SE-851 86
Country
Sweden
Facility Name
GSK Investigational Site
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bradford
ZIP/Postal Code
BD3 0DQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
West of Scotland Science Park, Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21592048
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVA102675
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
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