Trial · NCT00428090

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

NCT00428090, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-05-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease. Trials, record NCT00428090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00428090

On this page

Trial

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

Title: Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
NCT number: NCT00428090
Status: Completed
Phases: Phase 3
Enrollment: 862 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Alzheimer's Disease
Interventions: Rosiglitazone
First posted: 2007-01-29
Last updated: 2017-05-19
Results first posted: 2017-05-19

Source ClinicalTrials.gov

Registered outcomes27

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

List	Outcome	Time frame	Description
Primary	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	Baseline (W0) and W24	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.
Primary	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	Baseline (W0) and W24	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.
Primary	Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort	Baseline (W0) and W24	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.
Primary	Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort	Baseline (W0) and 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 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.
Primary	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	Baseline (W0) and 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 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.
Primary	Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort	Baseline (W0) and 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 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.
Secondary	Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24	Baseline (W0) and up to 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.
Secondary	Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24	Baseline (W0) and up to 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.
Secondary	Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24	Baseline (W0) and up to 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.
Secondary	Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24	Baseline (W0) and up to 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.

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes27

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	Baseline (W0) and W24	ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted for APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3) cohort	Score on a scale	LEAST_SQUARES_MEAN
PRIMARY	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	Baseline (W0) and W24	ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4's: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)	Score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort	Baseline (W0) and W24	ITT Population	Score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort	Baseline (W0) and W24	ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3).	Score on a scale	LEAST_SQUARES_MEAN
PRIMARY	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	Baseline (W0) and W24	ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4's: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)	Score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort	Baseline (W0) and W24	ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in full population.	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24	Baseline (W0) and up to W24	ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24	Baseline (W0) and up to W24	ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24	Baseline (W0) and up to W24	ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles). Endpoint treatment differences which were adjusted to take account of missing data are derived.	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24	Baseline (W0) and up to W24	ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).	Score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 27Source ClinicalTrials.gov

See all 27 outcomes

Results by group412

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

Outcome	Group	Value	Spread	Units
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	Placebo	1.6	Standard Error 0.78	Score on a scale
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	RSG XR 2 mg	-0.2	Standard Error 0.67	Score on a scale
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	RSG XR 8 mg	0.6	Standard Error 0.67	Score on a scale
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	Donepezil 10 mg	0.9	Standard Error 1.16	Score on a scale
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	Placebo	1.5	Standard Error 0.58	Score on a scale
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	RSG XR 2 mg	0.3	Standard Error 0.54	Score on a scale
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	RSG XR 8 mg	0.7	Standard Error 0.57	Score on a scale
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	Donepezil 10 mg	-0.1	Standard Error 0.79	Score on a scale
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort	Placebo	2.0	Standard Error 0.56	Score on a scale
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort	RSG XR 2 mg	1.2	Standard Error 0.53	Score on a scale

1 to 10 of 412Source ClinicalTrials.gov

See all 412 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	165
Overall Study	STARTED	RSG XR 2 mg	166
Overall Study	STARTED	RSG XR 8 mg	165
Overall Study	STARTED	Donepezil 10 mg	83
Overall Study	COMPLETED	Placebo	131
Overall Study	COMPLETED	RSG XR 2 mg	135
Overall Study	COMPLETED	RSG XR 8 mg	127
Overall Study	COMPLETED	Donepezil 10 mg	55
Overall Study	NOT COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	RSG XR 2 mg	31

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events164

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	165
other	Oedema peripheral	General disorders	RSG XR 2 mg	6	166
other	Oedema peripheral	General disorders	RSG XR 8 mg	24	165
other	Oedema peripheral	General disorders	Donepezil 10 mg	3	83
other	Nasopharyngitis	Infections and infestations	Placebo	4	165
other	Nasopharyngitis	Infections and infestations	RSG XR 2 mg	11	166
other	Nasopharyngitis	Infections and infestations	RSG XR 8 mg	4	165
other	Nasopharyngitis	Infections and infestations	Donepezil 10 mg	1	83
other	Hyperlipidaemia	Metabolism and nutrition disorders	Placebo	1	165
other	Hyperlipidaemia	Metabolism and nutrition disorders	RSG XR 2 mg	9	166

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	165
Total, all-cause mortality	RSG XR 2 mg	0	166
Total, all-cause mortality	RSG XR 8 mg	1	165
Total, all-cause mortality	Donepezil 10 mg	0	83
Total, other adverse events	Placebo	13	165
Total, other adverse events	RSG XR 2 mg	25	166
Total, other adverse events	RSG XR 8 mg	30	165
Total, other adverse events	Donepezil 10 mg	11	83
Total, serious adverse events	Placebo	10	165
Total, serious adverse events	RSG XR 2 mg	7	166

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20733306	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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00428090

GET https://conductscience.org/api/trials/v1/NCT00428090/registered?page=2

API reference For AI assistants