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Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Rosiglitazone

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring apolipoprotein E, monotherapy, cognition, mild, rosiglitazone, Alzheimer's disease, moderate

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Clinical diagnosis of probable Alzheimer's Disease (AD).
MMSE score 10 to 23
Has not taken an approved AD therapy in last 30 days.
No previous hypersensitivity/intolerance to AChEIs
Have a regular caregiver.

Exclusion criteria:

Diagnosis of vascular dementia.
Type I or secondary diabetes mellitus.
Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Rosiglitazone

Placebo

Arm Description

XR (extended release) oral tablets

Placebo (Double-Dummy to Match)

Outcomes

Primary Outcome Measures

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort

The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort

The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Secondary Outcome Measures

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24

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 5-point scale. Scores ranged from 0-70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Endpoint treatment differences were adjusted to take account of missing data. It was evaluated at Baseline, W8, W16 and W24.

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24

The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means more dysfunction. The scale was based on interviews with the par. and caregiver and was completed by an independent rater. It required separate structured 15-20 minute interviews with the par. and caregiver. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. It was evaluated at Baseline, W8, W16 and W24.

Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24

The NPI assessed behavioral disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The par. caregiver asked about behavior in the par. If "Yes", the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score can be calculated by adding all domain scores together; NPI total score: from 0-144 and NPI distress score: from 0-60, all with higher scores indicating more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24

The DAD, assessed the ability of a par. 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 participants' 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. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24

Change from Baseline in short term memory assessment score was assessed from a combined analysis of items 1 (word recall task) and 7 (word recognition task) of ADAS-Cog scale. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). Higher score indicating greater dysfunction. Total score is sum of individual score. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility

The EQ-5D Proxy was a 2 part scale used to assess the quality of life and utility benefit. The data for Part 1 is presented. It is a 5 dimensional Health State Classification. Caregivers were asked to respond as they feel the par. would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to each question were recorded on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])

The EQ-5D Proxy is a 2 part scale used to assess the quality of life and utility benefit. The data for Part 2 is presented. It is a the visual analogue scale Thermometer which assessed caregiver's impression of par. overall health. The Thermometer has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24

The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented par. RUD assess both formal and informal resource use of the par. and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 relates to assisting par. with basic activities of daily living and Q2 relates to instrumental activities of daily living. The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.

The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer's quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0-30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0-100 (100: worse). The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.

The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the par. and takes approximately 5 to 10 minutes to administer. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived

Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.

The blood sample was collected for assessments of HbA1c levels at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.

Number of Participants With Adverse Events Defined by Severity

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE included significant or unexpected worsening or exacerbation of the condition/indication under study, exacerbation of a chronic or intermittent pre-existing condition, new conditions detected or diagnosed, signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concurrent medication. Number of participants with any AE and as per severity were reported. Refer to the general AE/SAE module for a list of AEs and SAEs.

Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).

SBP, DBP and HR of par. were recorded in sitting posture as vital signs, while body weight was measured without shoes and wearing light clothing at each visit. The blood pressure (BP) and HR values were identified as of PCC if the vales were out of the reference range (for SBP, 90 to 140 millimeters of mercury (mmHg), DBP, 50 to 90 mmHg, and HR >100 or <50 beats per minute [bpm]) or meet a change from Baseline criterion. For SBP it was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg; decrease from Baseline (low) if decreased by >=30 mmHg. For DBP, increase from Baseline (high) if increased by >=30 mmHg; decrease from Baseline (low) if decreased by >=20 mmHg. For HR, increase from Baseline (high) if increased by >=30 bpm; decrease from Baseline (low) if decreased by >=30 bpm. For weight, increase from Baseline (high) if increased by >=7%; decrease from Baseline (low) if decreased by >=7%. Baseline was defined as value at W0.

Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)

Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG parameters includes PR interval, QRS duration, QT - uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval of Central Cardiologist are reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.

Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)

Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG HR of Central Cardiologist reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.

Change From Baseline (W0) in Body Weight

Body weight will be measured at all visits, without shoes and wearing light clothing. The assessments was performed at Baseline, W4, W8, W12, W16, and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Change From Baseline (W0) in Hemoglobin

Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Change From Baseline (W0) in Hematocrit

Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Change From Baseline (W0) in Periodic HbA1c Assessment

HbA1c assessment was performed par. with type 2 diabetes mellitus or HbA1c >=6.5% at Screening only. HbA1c levels were assessed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment

Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC, 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5-AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), neutrophils (0.75-1.5), lymphocytes (0.75-1.5), monocytes (0.75-2), eosinophils (none-2), basophils (none-2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC, 0.8-1.2), red cell distribution width (RDW, 0.8-1.2). Data for mean platelet volume (reference range not established) not reported

Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment

Clinical chemistry parameters were identified as of PCC (H, L), if values were out of RR: Alanine aminotransferase (ALT, none-120 [250% upper limit of RR, ULRR]), Albumin (0.75-2), Aspartate aminotransferase (AST,none-105 (3-64y), 137.5 (65+y), >250%ULRR), Alkaline phosphatase (ALP,none-312.5 (20+y), >250%ULRR), blood urea nitrogen (BUN)/Creatinine ratio (none-1.25), BUN (none-11), Chloride (80-115), Calcium (0.75-1.25), Carbon dioxide (CO2, 15-40) content, Creatinine (22, <50% lower limit of RR [LLRR]-155, >125%ULRR), Creatine phosphokinase (CPK, none-1.25), Gamma glutamyl transferase (GGT,none-2.5), Glucose (3.6-7.8), High density lipoprotein (HDL,0.65-none), Lactate dehydrogenase (LDH,none-1.25), Low density lipoprotein (LDL,none-2), Magnesium (0.5-2), Potassium (3-5.5), Phosphorus inorganic (0.5-1.5), Sodium (130-150), Total protein (0.8-1.5), Total cholesterol (none-1.25), Total bilirubin (none-1.95), Triglycerides (none-9). Data for Creatinine clearance not reported.

Full Information

NCT ID

NCT00428090

First Posted

January 25, 2007

Last Updated

April 13, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00428090

Brief Title

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

Official Title

A 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease. (REFLECT-1)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 27, 2007 (undefined)

Primary Completion Date

September 1, 2008 (Actual)

Study Completion Date

September 5, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.

Detailed Description

A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease. (REFLECT-1)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

apolipoprotein E, monotherapy, cognition, mild, rosiglitazone, Alzheimer's disease, moderate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

862 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosiglitazone

Arm Type

Experimental

Arm Description

XR (extended release) oral tablets

Arm Title

Placebo

Arm Type

Other

Arm Description

Placebo (Double-Dummy to Match)

Intervention Type

Drug

Intervention Name(s)

Rosiglitazone

Intervention Description

XR (extended release) oral tablets

Primary Outcome Measure Information:

Title

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort

Description

Time Frame

Baseline (W0) and W24

Title

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Description

The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.

Time Frame

Baseline (W0) and W24

Title

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Description

The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.

Time Frame

Baseline (W0) and W24

Title

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort

Description

Time Frame

Baseline (W0) and W24

Title

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Description

Time Frame

Baseline (W0) and W24

Title

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Description

Time Frame

Baseline (W0) and W24

Secondary Outcome Measure Information:

Title

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24

Description

The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means more dysfunction. The scale was based on interviews with the par. and caregiver and was completed by an independent rater. It required separate structured 15-20 minute interviews with the par. and caregiver. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. It was evaluated at Baseline, W8, W16 and W24.

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])

Description

Time Frame

Baseline (W0) and up to W24

Title

Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.

Description

Time Frame

Baseline (W0) and W24

Title

Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.

Description

Time Frame

Baseline (W0) and W24

Title

Number of Participants With Adverse Events Defined by Severity

Description

Time Frame

Up to W24

Title

Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).

Description

Time Frame

Up to W24

Title

Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)

Description

Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG HR of Central Cardiologist reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Body Weight

Description

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Hemoglobin

Description

Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Time Frame

Baseline (W0) and up to W24

Title

Change From Baseline (W0) in Hematocrit

Description

Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.

Time Frame

Baseline (W0) and Up to W24

Title

Change From Baseline (W0) in Periodic HbA1c Assessment

Description

Time Frame

Baseline (W0) and up to W24

Title

Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment

Description

Time Frame

Up to W24

Title

Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment

Description

Time Frame

Up to W24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Clinical diagnosis of probable Alzheimer's Disease (AD). MMSE score 10 to 23 Has not taken an approved AD therapy in last 30 days. No previous hypersensitivity/intolerance to AChEIs Have a regular caregiver. Exclusion criteria: Diagnosis of vascular dementia. Type I or secondary diabetes mellitus. Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide. History or evidence of congestive heart failure, clinically significant peripheral edema or anemia. History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

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

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

GSK Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

GSK Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

GSK Investigational Site

City

Reseda

State/Province

California

ZIP/Postal Code

91355

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

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

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

GSK Investigational Site

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

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

Destin

State/Province

Florida

ZIP/Postal Code

32541

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

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

GSK Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

GSK Investigational Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33647

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

GSK Investigational Site

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89146

Country

United States

Facility Name

GSK Investigational Site

City

Kenilworth

State/Province

New Jersey

ZIP/Postal Code

07033

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

12208

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

Centerville

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44120

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

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

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73118

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

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

35105

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

GSK Investigational Site

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3900

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Middleton

State/Province

Wisconsin

ZIP/Postal Code

53562-2215

Country

United States

Facility Name

GSK Investigational Site

City

Graz-Eggenberg

ZIP/Postal Code

A-8020

Country

Austria

Facility Name

GSK Investigational Site

City

Hall in Tirol

ZIP/Postal Code

A-6060

Country

Austria

Facility Name

GSK Investigational Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

GSK Investigational Site

City

Linz

ZIP/Postal Code

A-4020

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-1090

Country

Austria

Facility Name

GSK Investigational Site

City

Vienna

ZIP/Postal Code

A-1130

Country

Austria

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

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

Providencia / Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

GSK Investigational Site

City

Puente Alto - Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8207257

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

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510370

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100083

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

GSK Investigational Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

GSK Investigational Site

City

Dubrovnik

ZIP/Postal Code

20000

Country

Croatia

Facility Name

GSK Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10614

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Ellwangen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73479

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

89073

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

Guenzburg

State/Province

Bayern

ZIP/Postal Code

89312

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

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

Unterhaching

State/Province

Bayern

ZIP/Postal Code

82008

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

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19053

Country

Germany

Facility Name

GSK Investigational Site

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19055

Country

Germany

Facility Name

GSK Investigational Site

City

Achim

State/Province

Niedersachsen

ZIP/Postal Code

28832

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30559

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

Bielefeld

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

33647

Country

Germany

Facility Name

GSK Investigational Site

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44892

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

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

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06122

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

04103

Country

Germany

Facility Name

GSK Investigational Site

City

Itzehoe

State/Province

Schleswig-Holstein

ZIP/Postal Code

25524

Country

Germany

Facility Name

GSK Investigational Site

City

Gera

State/Province

Thueringen

ZIP/Postal Code

07551

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

13125

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22083

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 21

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

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

GSK Investigational Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

GSK Investigational Site

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

GSK Investigational Site

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

GSK Investigational Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

GSK Investigational Site

City

Bangalore

ZIP/Postal Code

560034

Country

India

Facility Name

GSK Investigational Site

City

Nagpur

ZIP/Postal Code

440010

Country

India

Facility Name

GSK Investigational Site

City

Tirupati

ZIP/Postal Code

517507

Country

India

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

143-729

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Saltillo

State/Province

Coahuila

ZIP/Postal Code

25000

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64660

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

14000

Country

Mexico

Facility Name

GSK Investigational Site

City

Auckland

ZIP/Postal Code

0622

Country

New Zealand

Facility Name

GSK Investigational Site

City

Karachi

ZIP/Postal Code

74800

Country

Pakistan

Facility Name

GSK Investigational Site

City

Lahore

ZIP/Postal Code

54000

Country

Pakistan

Facility Name

GSK Investigational Site

City

Lahore

ZIP/Postal Code

54590

Country

Pakistan

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 13

Country

Peru

Facility Name

GSK Investigational Site

City

Pasig City

ZIP/Postal Code

1600

Country

Philippines

Facility Name

GSK Investigational Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

GSK Investigational Site

City

Cabo Rojo

ZIP/Postal Code

623

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

90660

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115552

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

117049

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St.-Petersburg

ZIP/Postal Code

198103

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bradford

ZIP/Postal Code

BD3 0DQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Derriford, Plymouth

ZIP/Postal Code

PL6 8BX

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

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

20733306

Citation

Gold M, Alderton C, Zvartau-Hind M, Egginton S, Saunders AM, Irizarry M, Craft S, Landreth G, Linnamagi U, Sawchak S. Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: results from a randomized, double-blind, placebo-controlled phase III study. Dement Geriatr Cogn Disord. 2010;30(2):131-46. doi: 10.1159/000318845. Epub 2010 Aug 21.

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

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105640

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

105640

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

105640

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

105640

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105640

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

105640

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

105640

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

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Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

Alzheimer's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial