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Trial · NCT00736996

Pioglitazone Or Exercise to Treat Mild Cognitive Impairment (MCI)

NCT00736996, Phase 2, Completed, University of Colorado, Denver; results first posted 2016-01-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pioglitazone Or Exercise to Treat Mild Cognitive Impairment (MCI). Trials, record NCT00736996. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00736996

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Trial

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

Title
Pioglitazone Or Exercise to Treat Mild Cognitive Impairment (MCI)
NCT number
NCT00736996
Status
Completed
Phases
Phase 2
Enrollment
78 participants, actual
Lead sponsor
University of Colorado, Denver
Conditions
Mild Cognitive Impairment
Interventions
Pioglitazone, Placebo, Endurance Exercise Training
First posted
2008-08-18
Last updated
2016-01-15
Results first posted
2016-01-15

Source ClinicalTrials.gov

Registered outcomes3

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

ListOutcomeTime frameDescription
PrimaryChange in Cognitive PerformanceBaseline to 6 months
Participants were administered a neuropsychological testing battery consisting of assessments in four cognitive domains: memory (Visual Reproduction II, Logical Memory II, Rey Auditory Verbal Learning Test), language (Boston Naming Test , Category Fluency), visuospatial (Block Design, Picture Completion), and executive function (Trail Making Test B, Digit Symbol Test). Raw test scores for these primary cognitive domain measures were transformed into age-adjusted scaled scores with a mean of 10 and a standard deviation (SD) of 3, with higher numbers indicating better cognitive performance, using the Mayo's Older American Normative Studies data. Cognitive domain scores were calculated as the arithmetic mean of the normatively derived scaled scores for all of the tests in that domain.
SecondaryChange in Insulin ResistanceBaseline to 6 monthsChange in whole body glucose disposal rate (mg/kg/min) calculated during a single-stage (40 mU/m2/min), 3-hour hyperinsulinemic, euglycemic clamp
SecondaryChange in Peak Oxygen Uptake (VO2 Peak)Baseline to 6 monthsPeak oxygen consumption (VO2 peak, ml/kg/min) was determined by open circuit spirometry during a standard treadmill stress test (modified Balke protocol).

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Cognitive PerformanceBaseline to 6 monthsunits on a scaleNUMBER
SECONDARYChange in Insulin ResistanceBaseline to 6 monthsmg/kg/minNUMBER
SECONDARYChange in Peak Oxygen Uptake (VO2 Peak)Baseline to 6 monthsml/kg/minNUMBER

Results by group18

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

OutcomeGroupCategoryValueSpreadUnits
Change in Cognitive PerformancePioglitazoneMemory domain0.895% Confidence Interval -1.4 to 2.9units on a scale
Change in Cognitive PerformanceEndurance Exercise TrainingMemory domain0.795% Confidence Interval -1.5 to 2.8units on a scale
Change in Cognitive PerformancePlaceboMemory domain1.295% Confidence Interval -1.0 to 3.4units on a scale
Change in Cognitive PerformancePioglitazoneLanguage domain0.495% Confidence Interval -1.8 to 2.6units on a scale
Change in Cognitive PerformanceEndurance Exercise TrainingLanguage domain0.695% Confidence Interval -1.6 to 2.8units on a scale
Change in Cognitive PerformancePlaceboLanguage domain0.495% Confidence Interval -1.9 to 2.6units on a scale
Change in Cognitive PerformancePioglitazoneVisuospatial domain0.395% Confidence Interval -1.7 to 2.3units on a scale
Change in Cognitive PerformanceEndurance Exercise TrainingVisuospatial domain1.195% Confidence Interval -0.9 to 3.1units on a scale
Change in Cognitive PerformancePlaceboVisuospatial domain0.895% Confidence Interval -1.2 to 2.8units on a scale
Change in Cognitive PerformancePioglitazoneExecutive function domain1.095% Confidence Interval -0.9 to 3.0units on a scale

Participant flow9

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPioglitazone25
Overall StudySTARTEDEndurance Exercise Training26
Overall StudySTARTEDPlacebo27
Overall StudyCOMPLETEDPioglitazone24
Overall StudyCOMPLETEDEndurance Exercise Training17
Overall StudyCOMPLETEDPlacebo25
Overall StudyNOT COMPLETEDPioglitazone1
Overall StudyNOT COMPLETEDEndurance Exercise Training9
Overall StudyNOT COMPLETEDPlacebo2

Adverse events63

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherMusculoskeletalMusculoskeletal and connective tissue disordersPioglitazone3254
otherMusculoskeletalMusculoskeletal and connective tissue disordersEndurance Exercise Training112611
otherMusculoskeletalMusculoskeletal and connective tissue disordersPlacebo6276
otherCardiovascularCardiac disordersPioglitazone4255
otherCardiovascularCardiac disordersEndurance Exercise Training2262
otherCardiovascularCardiac disordersPlacebo4275
otherDermatologicSkin and subcutaneous tissue disordersPioglitazone3254
otherDermatologicSkin and subcutaneous tissue disordersEndurance Exercise Training1261
otherDermatologicSkin and subcutaneous tissue disordersPlacebo5275
otherGastrointestinalGastrointestinal disordersPioglitazone5256

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPioglitazone
Total, all-cause mortalityEndurance Exercise Training
Total, all-cause mortalityPlacebo
Total, other adverse eventsPioglitazone1825
Total, other adverse eventsEndurance Exercise Training1926
Total, other adverse eventsPlacebo2327
Total, serious adverse eventsPioglitazone325
Total, serious adverse eventsEndurance Exercise Training126
Total, serious adverse eventsPlacebo327

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
15249848BACKGROUNDPubMed
15536110BACKGROUNDPubMed
15750215BACKGROUNDPubMed
16286438BACKGROUNDPubMed
16778001BACKGROUNDPubMed

Grants1

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01AG028746Pioglitazone & Exercise Effects on Older Aldults with MCI and Metabolic SyndromeSCHWARTZ, ROBERT SUNIVERSITY OF COLORADO DENVERNATIONAL INSTITUTE ON AGING2008 to 2010

Trial comparisons0

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

None in this release.

Tests7

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

TestNamed asSource
Category FluencyPrimary outcomeConductCognition
Picture Naming TestPrimary outcomeConductCognition
Short Story RecallPrimary outcomeConductCognition
Symbol CodingPrimary outcomeConductCognition
Trail Making Test APrimary outcomeConductCognition
Trail Making Test BPrimary outcomeConductCognition
Verbal LearningPrimary outcomeConductCognition

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/NCT00736996

GET https://conductscience.org/api/trials/v1/NCT00736996/events?page=2