Adults 50 to 90, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives CohortPrimary· Baseline (Week 0) and Week 48
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 range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was u
Group
Value
95% CI
Placebo
3.2
± 0.54
RSG XR 2mg
3.5
± 0.53
RSG XR 8mg
4.0
± 0.63
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s CohortPrimary· Baseline (Week 0) and Week 48
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 range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was
Group
Value
95% CI
Placebo
3.8
± 0.38
RSG XR 2mg
3.6
± 0.35
RSG XR 8mg
3.8
± 0.41
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population CohortPrimary· Baseline (Week 0) and Week 48
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 range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was
Group
Value
95% CI
Placebo
3.9
± 0.35
RSG XR 2mg
3.8
± 0.33
RSG XR 8mg
3.8
± 0.36
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives CohortPrimary· Baseline (Week 0) and Week 48
The CDR-SB was a validated clinical assessment of global function in patients with 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", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means
Group
Value
95% CI
Placebo
1.8
± 0.20
RSG XR 2mg
1.7
± 0.20
RSG XR 8mg
1.7
± 0.17
Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s CohortPrimary· Baseline (Week 0) and Week 48
The CDR-SB was a validated clinical assessment of global function in patients with 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", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means
Group
Value
95% CI
Placebo
1.8
± 0.13
RSG XR 2mg
1.8
± 0.13
RSG XR 8mg
1.7
± 0.13
Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population CohortPrimary· Baseline (Week 0) and Week 48
The CDR-SB was a validated clinical assessment of global function in patients with 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", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means
Group
Value
95% CI
Placebo
1.9
± 0.12
RSG XR 2mg
1.8
± 0.13
RSG XR 8mg
1.8
± 0.12
Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36Secondary· Baseline (Week 0) and Week 8, 16, 24, 36
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 range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. It was calculated at Weeks 8, 16, 24 and 36. Full population data was presented.
Week 8
Group
Value
95% CI
Placebo
0.1
± 0.23
RSG XR 2mg
0.2
± 0.23
RSG XR 8mg
0.3
± 0.23
Week 16
Group
Value
95% CI
Placebo
0.2
± 0.24
RSG XR 2mg
0.3
± 0.23
RSG XR 8mg
0.2
± 0.24
Week 24
Group
Value
95% CI
Placebo
1.1
± 0.26
RSG XR 2mg
1.5
± 0.28
RSG XR 8mg
1.1
± 0.27
Week 36
Group
Value
95% CI
Placebo
2.6
± 0.31
RSG XR 2mg
2.8
± 0.29
RSG XR 8mg
2.6
± 0.31
Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36Secondary· Baseline (Week 0) and Week 12, 24, 36
The CDR-SB was a validated clinical assessment of global function in patients with 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", can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means
Week 12
Group
Value
95% CI
Placebo
0.3
± 0.07
RSG XR 2mg
0.4
± 0.08
RSG XR 8mg
0.3
± 0.07
Week 24
Group
Value
95% CI
Placebo
0.9
± 0.10
RSG XR 2mg
0.8
± 0.10
RSG XR 8mg
0.9
± 0.09
Week 36
Group
Value
95% CI
Placebo
1.4
± 0.11
RSG XR 2mg
1.3
± 0.11
RSG XR 8mg
1.3
± 0.10
Change From Screening in Mini Mental State Examination (MMSE) Total ScoreSecondary· Screening (Week -4) and Week 48
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 participant. Change from screening was calculated as value at scheduled time point minus screening value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.
Group
Value
95% CI
Placebo
-2.0
± 0.21
RSG XR 2mg
-2.3
± 0.22
RSG XR 8mg
-2.0
± 0.22
Change From Baseline in Disability Assessment for Dementia (DAD) Total ScoreSecondary· Baseline (Week 0) and Week 8, 16, 24, 48
The 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 assessed 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 d
Week 8
Group
Value
95% CI
Placebo
-2.3
± 0.50
RSG XR 2mg
-1.2
± 0.50
RSG XR 8mg
-2.3
± 0.46
Week 16
Group
Value
95% CI
Placebo
-3.0
± 0.57
RSG XR 2mg
-2.3
± 0.55
RSG XR 8mg
-3.9
± 0.59
Week 24
Group
Value
95% CI
Placebo
-4.6
± 0.60
RSG XR 2mg
-2.8
± 0.62
RSG XR 8mg
-4.7
± 0.63
Week 48
Group
Value
95% CI
Placebo
-9.5
± 0.81
RSG XR 2mg
-9.4
± 0.81
RSG XR 8mg
-10.4
± 0.82
Change From Baseline in Neuropsychiatric Inventory (NPI) Total ScoreSecondary· Baseline (Week 0) and Week 8, 16, 24, 48
NPI is an assessment of frequency and severity of behavioral disturbances in dementia that comprised of 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety, aberrant motor activity. Participant's caregiver asked about behavior in participant. If "Yes", informant then rated both severity on a 3-point scale, 1-mild to 3-severe (total range: 0-36) and frequency using a 4-point scale, 1-occasionally to 4-very frequently. Total score was frequency × severity. Distress was scored on 5-point scale, 0-no distress to
Week 8
Group
Value
95% CI
Placebo
-0.0
± 0.32
RSG XR 2mg
-0.3
± 0.33
RSG XR 8mg
-0.2
± 0.31
Week 16
Group
Value
95% CI
Placebo
0.1
± 0.34
RSG XR 2mg
0.2
± 0.37
RSG XR 8mg
0.1
± 0.37
Week 24
Group
Value
95% CI
Placebo
1.3
± 0.43
RSG XR 2mg
0.3
± 0.41
RSG XR 8mg
0.2
± 0.39
Week 48
Group
Value
95% CI
Placebo
2.6
± 0.52
RSG XR 2mg
1.5
± 0.49
RSG XR 8mg
1.9
± 0.50
Change From Baseline in Domains of the Resource Utilization in Dementia Scale (RUD)- Q1 and Q2 Caregiver HoursSecondary· Baseline (Week 0) and Week 12, 24, 36, 48
The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented patients. RUD assessd both formal and informal resource use of the patient and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 corresponds to the number of hours during the last month the caregiver spent assisting the patient with toilet visits, eating, dressing, grooming, walking and bathing and Q2 corresponds to the number of hours during the last month the caregiver spent assisting the patient with shopping, food preparation, housekeeping,
Q1 Week 12
Group
Value
95% CI
Placebo
-2.4
± 2.72
RSG XR 2mg
1.8
± 2.56
RSG XR 8mg
3.5
± 2.68
Q1 Week 24
Group
Value
95% CI
Placebo
7.4
± 3.43
RSG XR 2mg
9.0
± 2.92
RSG XR 8mg
10.9
± 3.69
Q1 Week 36
Group
Value
95% CI
Placebo
11.2
± 4.36
RSG XR 2mg
12.7
± 3.70
RSG XR 8mg
13.4
± 4.09
Q1 Week 48
Group
Value
95% CI
Placebo
15.7
± 4.14
RSG XR 2mg
19.7
± 4.06
RSG XR 8mg
19.2
± 4.54
Q2 Week 12
Group
Value
95% CI
Placebo
-1.1
± 4.06
RSG XR 2mg
5.8
± 3.70
RSG XR 8mg
6.4
± 4.04
Q2 Week 24
Group
Value
95% CI
Placebo
5.6
± 4.41
RSG XR 2mg
15.6
± 4.90
RSG XR 8mg
12.3
± 4.79
Q2 Week 36
Group
Value
95% CI
Placebo
16.4
± 5.52
RSG XR 2mg
23.4
± 6.10
RSG XR 8mg
15.2
± 4.53
Q2 Week 48
Group
Value
95% CI
Placebo
21.8
± 5.62
RSG XR 2mg
26.0
± 5.69
RSG XR 8mg
21.6
± 4.92
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product until Week 54 following early withdrawal of the study medication/follow up.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 60/487 (12%)
Deaths: 9/487
RSG XR 2mg
Serious: 58/490 (12%)
Deaths: 11/490
RSG XR 8mg
Serious: 66/491 (13%)
Deaths: 11/491
Serious adverse events (148 terms)
Reaction
System
Placebo
RSG XR 2mg
RSG XR 8mg
Syncope
Nervous system disorders
—
—
—
Cerebrovascular accident
Nervous system disorders
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
Pneumonia
Infections and infestations
—
—
—
Bronchitis
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Cardiac failure
Cardiac disorders
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
Nervous system disorder
Nervous system disorders
—
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
—
Pelvic fracture
Injury, poisoning and procedural complications
—
—
—
Humerus fracture
Injury, poisoning and procedural complications
—
—
—
Arrhythmia
Cardiac disorders
—
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.
This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 5 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00348140.