Trial · NCT00348140

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

NCT00348140, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-09-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease. Trials, record NCT00348140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348140

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease
NCT number: NCT00348140
Status: Completed
Phases: Phase 3
Enrollment: 1,468 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Alzheimer's Disease
Interventions: Rosiglitazone Extended Release 2mg, Rosiglitazone Extended Release 8mg, Placebo
First posted: 2006-07-04
Last updated: 2017-09-05
Results first posted: 2017-09-05

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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 Cohort	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 used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Primary	Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	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 used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Primary	Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	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 used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Primary	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 Cohort	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 were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Primary	Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	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 were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Primary	Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	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 were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.
Secondary	Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36	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.
Secondary	Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36	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 were presented. It was calculated at Weeks 12, 24 and 36. Full population data was presented.
Secondary	Change From Screening in Mini Mental State Examination (MMSE) Total Score	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.
Secondary	Change From Baseline in Disability Assessment for Dementia (DAD) Total Score	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 disability and 0 indicating no functional ability. The percentage score was calculated as (DAD Total score /Total number of applicable items) multiplied by 100. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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 Cohort	Baseline (Week 0) and Week 48	ITT population comprised of all participants randomized to treatment, who had taken at least one dose of study medication and who had at least one post baseline efficacy assessment. Number of participants with observed data contributing to the analysis have been presented.	Scores on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	Baseline (Week 0) and Week 48	ITT population. Number of participants with observed data contributing to the analysis have been presented.	Scores on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	Baseline (Week 0) and Week 48	ITT population. Number of participants with observed data contributing to the analysis have been presented.	Scores on a scale	LEAST_SQUARES_MEAN
PRIMARY	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 Cohort	Baseline (Week 0) and Week 48	ITT population. Number of participants with observed data contributing to the analysis have been presented.	Scores on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	Baseline (Week 0) and Week 48	ITT population. Number of participants with observed data contributing to the analysis have been presented.	Scores on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	Baseline (Week 0) and Week 48	ITT population. Number of participants with observed data contributing to the analysis have been presented.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36	Baseline (Week 0) and Week 8, 16, 24, 36	ITT population. Number of participants with observed data contributing to the analysis.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36	Baseline (Week 0) and Week 12, 24, 36	ITT population. Number of participants with observed data contributing to the analysis.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Screening in Mini Mental State Examination (MMSE) Total Score	Screening (Week -4) and Week 48	ITT population. Only those participants available at that particular time point were analyzed.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Disability Assessment for Dementia (DAD) Total Score	Baseline (Week 0) and Week 8, 16, 24, 48	ITT population. Number of participants with observed data contributing to the analysis.	Scores on a scale	LEAST_SQUARES_MEAN

1 to 10 of 31Source ClinicalTrials.gov

See all 31 outcomes

Results by group714

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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 Cohort	Placebo	3.2	Standard Error 0.54	Scores on a scale
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 Cohort	RSG XR 2mg	3.5	Standard Error 0.53	Scores on a scale
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 Cohort	RSG XR 8mg	4.0	Standard Error 0.63	Scores on a scale
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	Placebo	3.8	Standard Error 0.38	Scores on a scale
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	RSG XR 2mg	3.6	Standard Error 0.35	Scores on a scale
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort	RSG XR 8mg	3.8	Standard Error 0.41	Scores on a scale
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	Placebo	3.9	Standard Error 0.35	Scores on a scale
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	RSG XR 2mg	3.8	Standard Error 0.33	Scores on a scale
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort	RSG XR 8mg	3.8	Standard Error 0.36	Scores on a scale
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 Cohort	Placebo	1.8	Standard Error 0.20	Scores on a scale

1 to 10 of 714Source ClinicalTrials.gov

See all 714 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	487
Overall Study	STARTED	RSG XR 2mg	490
Overall Study	STARTED	RSG XR 8mg	491
Overall Study	COMPLETED	Placebo	361
Overall Study	COMPLETED	RSG XR 2mg	351
Overall Study	COMPLETED	RSG XR 8mg	328
Overall Study	NOT COMPLETED	Placebo	126
Overall Study	NOT COMPLETED	RSG XR 2mg	139
Overall Study	NOT COMPLETED	RSG XR 8mg	163

Source ClinicalTrials.gov

Adverse events450

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Oedema peripheral	General disorders	Placebo	9	487
other	Oedema peripheral	General disorders	RSG XR 2mg	32	490
other	Oedema peripheral	General disorders	RSG XR 8mg	91	491
other	Anaemia	Blood and lymphatic system disorders	Placebo	2	487
other	Anaemia	Blood and lymphatic system disorders	RSG XR 2mg	10	490
other	Anaemia	Blood and lymphatic system disorders	RSG XR 8mg	25	491
serious	Syncope	Nervous system disorders	Placebo	5	487
serious	Syncope	Nervous system disorders	RSG XR 2mg	1	490
serious	Syncope	Nervous system disorders	RSG XR 8mg	3	491
serious	Cerebrovascular accident	Nervous system disorders	Placebo	1	487

1 to 10 of 450Source ClinicalTrials.gov

See all 450 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	9	487
Total, all-cause mortality	RSG XR 2mg	11	490
Total, all-cause mortality	RSG XR 8mg	11	491
Total, other adverse events	Placebo	11	487
Total, other adverse events	RSG XR 2mg	42	490
Total, other adverse events	RSG XR 8mg	100	491
Total, serious adverse events	Placebo	60	487
Total, serious adverse events	RSG XR 2mg	58	490
Total, serious adverse events	RSG XR 8mg	66	491

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21592048	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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