Trial · NCT00348309
Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease
NCT00348309, Not applicable, Completed, GlaxoSmithKline; results first posted 2017-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease. Trials, record NCT00348309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348309
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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 For Subjects With Mild To Moderate Alzheimer's Disease
- NCT number
- NCT00348309
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,496 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Alzheimer's Disease
- Interventions
- Rosiglitazone Extended Release 2mg, Rosiglitazone Extended Release 8mg, Placebo, Donepezil
- First posted
- 2006-07-04
- Last updated
- 2017-11-28
- Results first posted
- 2017-11-28
Source ClinicalTrials.gov
Registered outcomes22
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 | Baseline (Week 0) and Week 48 | ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in participants with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4's: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups. Least square mean is entered for adjusted mean. |
| Primary | Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4 | Baseline (Week 0) and Week 48 | CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4's: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups. |
| Secondary | Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score | Baseline (Week 0), Week 8, 16, 24 and 48 | The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). 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. The scale includes 23 items relating to instrumental activities of daily living and 17 items relating to basic self-care. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. Total score was obtained by adding the rating for each question and converting this total score out of 100. The total score ranged from 0 to 100, where higher score indicated better function and lower score indicated greater severity of symptoms; a positive change from baseline indicated an improvement. Change from baseline is calculated as endpoint value minus the baseline value. |
| Secondary | Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score | Baseline (Week 0), Week 8, 16, 24 and 48 | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. Change from baseline is calculated as endpoint value minus the baseline value. |
| 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. The scale was completed by the investigator, based on the performance of the participant, and took approximately 5 to 10 minutes to administer. The scores from 11 tests were combined to obtain the total score. The total scores range from 0 to 30, with lower scores indicating greater cognitive impairment and higher score indicating better outcome; a positive change from screening indicated an improvement. The total MMSE score for participants at screening was between 10 and 26, inclusive, in order to be eligible to participate in the trial. Change from screening is calculated as endpoint value minus the screening value. |
| Secondary | Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD) | Baseline (Week 0), Week 12, 24, 36 and 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, laundry, transportation, taking medication and managing financial matters. 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. |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility | Baseline (Week 0), Week 12, 36 and 48 | The EQ-5D Proxy is a two part scale that evaluated the participant's health status via Thermometer and Utility scores. The Thermometer score was the caregiver's rating of the participant's overall health status on a VAS (0 \["worst possible status"\] to 100 \["best imaginable status"\]). The Utility score was a caregiver rating of health status on dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression\] where '1' indicated better health state (no problems); '3' indicated worst health state ("confined to bed"). Total possible score was the sum of individual items, ranged from 5 to 15; lower score indicated a better health state and higher score indicated greater severity of symptoms. A positive change from baseline indicated improvement in the Thermometer score and a negative change from baseline indicated improvement in the Utility score. Change from baseline is calculated as endpoint value minus the baseline value. |
| Secondary | Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48 | Baseline (Week 0), Week 8, 16, 24, 36 and 48 | ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as endpoint value minus the baseline value. |
| Secondary | Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48 | Baseline (Week 0), Week 12, 24, 36 and 48 | CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as endpoint value minus the baseline value. |
| Secondary | Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48 | Week 48 and 54 | ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change was calculated as endpoint value (Week 54) minus Week 48 value. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 | Baseline (Week 0) and Week 48 | ITT population included all the participants who were randomized to treatment, who had received at least one dose of study medication and who had at least one post baseline efficacy assessment. Only those participants available at the specified time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4 | Baseline (Week 0) and Week 48 | ITT population. Only those participants available at the specified time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score | Baseline (Week 0), Week 8, 16, 24 and 48 | ITT population. Only those participants available at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score | Baseline (Week 0), Week 8, 16, 24 and 48 | ITT population. Only those participants available at the specified time points were analyzed. | Score 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 the specified time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD) | Baseline (Week 0), Week 12, 24, 36 and 48 | ITT population. Only those participants available at the specified time points were analyzed. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility | Baseline (Week 0), Week 12, 36 and 48 | ITT population. Only those participants available at the specified time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48 | Baseline (Week 0), Week 8, 16, 24, 36 and 48 | ITT population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48 | Baseline (Week 0), Week 12, 24, 36 and 48 | ITT population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48 | Week 48 and 54 | ITT population. Only those participants available at the specified time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group351
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | Placebo | APOE4 negatives | 2.9 | Standard Error 0.54 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 2mg Rosiglitazone Extended Release | APOE4 negatives | 1.6 | Standard Error 0.42 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 8mg Rosiglitazone Extended Release | APOE4 negatives | 2.7 | Standard Error 0.56 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | Placebo | All except E4/E4s | 3.1 | Standard Error 0.36 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 2mg Rosiglitazone Extended Release | All except E4/E4s | 2.1 | Standard Error 0.29 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 8mg Rosiglitazone Extended Release | All except E4/E4s | 3.1 | Standard Error 0.37 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | Placebo | Full populations | 3.4 | Standard Error 0.35 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 2mg Rosiglitazone Extended Release | Full populations | 2.4 | Standard Error 0.30 | Score on a scale |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48 | 8mg Rosiglitazone Extended Release | Full populations | 3.2 | Standard Error 0.35 | Score on a scale |
| Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4 | Placebo | APOE4 negatives | 1.3 | Standard Error 0.21 | Score on a scale |
1 to 10 of 351Source ClinicalTrials.gov
See all 351 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 496 | |
| Overall Study | STARTED | 2mg Rosiglitazone Extended Release | 494 | |
| Overall Study | STARTED | 8mg Rosiglitazone Extended Release | 489 | |
| Overall Study | COMPLETED | Placebo | 362 | |
| Overall Study | COMPLETED | 2mg Rosiglitazone Extended Release | 396 | |
| Overall Study | COMPLETED | 8mg Rosiglitazone Extended Release | 346 | |
| Overall Study | NOT COMPLETED | Placebo | 134 | |
| Overall Study | NOT COMPLETED | 2mg Rosiglitazone Extended Release | 98 | |
| Overall Study | NOT COMPLETED | 8mg Rosiglitazone Extended Release | 143 |
Source ClinicalTrials.gov
Adverse events390
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 | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Placebo | 11 | 496 | |
| other | Oedema peripheral | General disorders | 2mg Rosiglitazone Extended Release | 29 | 494 | |
| other | Oedema peripheral | General disorders | 8mg Rosiglitazone Extended Release | 69 | 489 | |
| serious | Hip fracture | Injury, poisoning and procedural complications | Placebo | 3 | 496 | |
| serious | Hip fracture | Injury, poisoning and procedural complications | 2mg Rosiglitazone Extended Release | 4 | 494 | |
| serious | Hip fracture | Injury, poisoning and procedural complications | 8mg Rosiglitazone Extended Release | 1 | 489 | |
| serious | Femoral neck fracture | Injury, poisoning and procedural complications | Placebo | 0 | 496 | |
| serious | Femoral neck fracture | Injury, poisoning and procedural complications | 2mg Rosiglitazone Extended Release | 1 | 494 | |
| serious | Femoral neck fracture | Injury, poisoning and procedural complications | 8mg Rosiglitazone Extended Release | 3 | 489 | |
| serious | Fall | Injury, poisoning and procedural complications | Placebo | 1 | 496 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 12 | 496 |
| Total, all-cause mortality | 2mg Rosiglitazone Extended Release | 6 | 494 |
| Total, all-cause mortality | 8mg Rosiglitazone Extended Release | 8 | 489 |
| Total, other adverse events | Placebo | 11 | 496 |
| Total, other adverse events | 2mg Rosiglitazone Extended Release | 29 | 494 |
| Total, other adverse events | 8mg Rosiglitazone Extended Release | 69 | 489 |
| Total, serious adverse events | Placebo | 62 | 496 |
| Total, serious adverse events | 2mg Rosiglitazone Extended Release | 45 | 494 |
| Total, serious adverse events | 8mg Rosiglitazone Extended Release | 50 | 489 |
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.
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/NCT00348309
GET https://conductscience.org/api/trials/v1/NCT00348309/registered?page=2