Trial · NCT01931566
Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset
NCT01931566, Phase 3, Terminated, Takeda; results first posted 2019-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset. Trials, record NCT01931566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01931566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset
- NCT number
- NCT01931566
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,494 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Mild Cognitive Impairment Due to Alzheimer's Disease
- Interventions
- Pioglitazone, Pioglitazone placebo
- First posted
- 2013-08-29
- Last updated
- 2019-09-16
- Other registries' IDs
- eudract:2012-003111-58
- Results first posted
- 2019-08-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants | Baseline to the end of study (approximately up to 5 years) | The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time. |
| Primary | Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants | Baseline to the end of study (approximately up to 5 years) | The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time. |
| Secondary | Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum | Baseline and Month 48 | Composite scores derived from the test battery. Domains of Episodic Memory \[California Verbal Learning Test-2nd Edition (CVLT-II), Brief Visuospatial Memory Test-Revised (BVMT-R)\]; Executive Function \[Trail Making Test (TMT) (Part B), Wechsler Adult Intelligence Scale (WAIS)-III Digit Span Test-backwards span\]; Language \[Multilingual Naming Test (MiNT), Semantic Fluency (animals), Lexical/phonemic fluency (F, A, and S in English; D, S, and F in German)\]; and Attention \[WAIS-III Digit Span Test-forward span, TMT (Part A)\] used for composite score. 12 measures were derived from 8 neuropsychological tests. CVLT-II test involved 2 primary measures (short, long delay recall); BVMT-R had 2 measures (copy and recall); Digit Span and Trail both had 2 measures (forward and backward span and Parts A and B). There was 1 total score for each test: CDT, MINT, semantic and lexical fluency. Total score ranged from -1.222 to 1.707 at baseline, a higher composite score indicated better cognition. |
| Secondary | Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum | Baseline and Month 48 | The ADCS ADL-PI is a functional measure that was specifically designed for standardized administration over long duration clinical studies to prevent AD. The ADCS ADL-PI is a 20-item instrument that included 15 ADL questions, which were scored as 1 (with a lot of difficulty), 2 (with some difficulty), or 3 (as well as usually, with no difficulty), plus 5 vision, hearing, and mobility questions, which were scored from 0 (no) to 1 (yes). ADL Total ranged from 0 to 45, and lower scores indicated greater disability. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants | Baseline to the end of study (approximately up to 5 years) | Full Analysis Set (FAS) included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. A participant who does not have an event of MCI due to AD was censored at the date of the last visit at which MCI due to AD could have been assessed. | days | MEAN |
| PRIMARY | Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants | Baseline to the end of study (approximately up to 5 years) | FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. A participant who does not have an event of MCI due to AD was censored at the date of the last visit at which MCI due to AD could have been assessed. | days | MEAN |
| SECONDARY | Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum | Baseline and Month 48 | FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. Number analyzed is the number of participants with evaluable data at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum | Baseline and Month 48 | FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. Number analyzed is the number of participants with evaluable data at the given time-point. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants | Low Risk Placebo | 905.44 | Full Range 189.00 to 909.00 | days | |
Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants | High Risk Placebo | 1238.67 | Full Range 168.00 to 1268.00 | days | |
| Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants | High Risk Placebo | 1238.67 | Full Range 168.00 to 1268.00 | days | |
| Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants | High Risk Pioglitazone | 1261.24 | Full Range 168.00 to 1285.00 | days | |
| Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum | High Risk Placebo | 0.1841 | Standard Deviation 0.27508 | score on a scale | |
| Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum | High Risk Pioglitazone | 0.1687 | Standard Deviation 0.40621 | score on a scale | |
Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum | High Risk Placebo | 0.1 | Standard Deviation 4.93 | score on a scale | |
Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum | High Risk Pioglitazone | 0.3 | Standard Deviation 5.32 | score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Risk Placebo | 433 | |
| Overall Study | STARTED | High Risk Placebo | 1,516 | |
| Overall Study | STARTED | High Risk Pioglitazone | 1,545 | |
| Overall Study | Treated | Low Risk Placebo | 427 | |
| Overall Study | Treated | High Risk Placebo | 1,507 | |
| Overall Study | Treated | High Risk Pioglitazone | 1,531 | |
| Overall Study | COMPLETED | Low Risk Placebo | 4 | |
| Overall Study | COMPLETED | High Risk Placebo | 40 | |
| Overall Study | COMPLETED | High Risk Pioglitazone | 39 | |
| Overall Study | NOT COMPLETED | Low Risk Placebo | 429 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,305
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 | Cataract | Eye disorders | Low Risk Placebo | 27 | 427 | |
| other | Cataract | Eye disorders | High Risk Placebo | 119 | 1,507 | |
| other | Cataract | Eye disorders | High Risk Pioglitazone | 106 | 1,531 | |
| other | Constipation | Gastrointestinal disorders | Low Risk Placebo | 24 | 427 | |
| other | Constipation | Gastrointestinal disorders | High Risk Placebo | 70 | 1,507 | |
| other | Constipation | Gastrointestinal disorders | High Risk Pioglitazone | 72 | 1,531 | |
| other | Upper respiratory tract infection | Infections and infestations | Low Risk Placebo | 62 | 427 | |
| other | Upper respiratory tract infection | Infections and infestations | High Risk Placebo | 190 | 1,507 | |
| other | Upper respiratory tract infection | Infections and infestations | High Risk Pioglitazone | 183 | 1,531 | |
| other | Urinary tract infection | Infections and infestations | Low Risk Placebo | 47 | 427 |
1 to 10 of 1,305Source ClinicalTrials.gov
See all 1,305 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Risk Placebo | 2 | 427 |
| Total, all-cause mortality | High Risk Placebo | 21 | 1,507 |
| Total, all-cause mortality | High Risk Pioglitazone | 7 | 1,531 |
| Total, other adverse events | Low Risk Placebo | 235 | 427 |
| Total, other adverse events | High Risk Placebo | 828 | 1,507 |
| Total, other adverse events | High Risk Pioglitazone | 822 | 1,531 |
| Total, serious adverse events | Low Risk Placebo | 81 | 427 |
| Total, serious adverse events | High Risk Placebo | 404 | 1,507 |
| Total, serious adverse events | High Risk Pioglitazone | 358 | 1,531 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT01931566
GET https://conductscience.org/api/trials/v1/NCT01931566/events?page=2