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NCT01931566 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3,494
- Enrollment target
NCT01931566: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01931566 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 3,494 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (353% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01931566, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3,494 participants
- Enrollment target
Study Summary
The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in cognitively-normal participants who are at high-risk for developing MCI within 5 years.
Primary Outcome
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.
Interventions
- DRUG Pioglitazone
- DRUG Pioglitazone placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,494 participants |
| Start Date | 2013-08-01 |
| Est. Completion | 2018-09-06 |
| Phase | Phase 3 |
Why NCT01931566 stopped before completion
NCT01931566 is an interventional study that assigns participants to a tested intervention. Its 3,494 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (353% higher).
The record links to 0 conditions, and to 2 interventions - of which Pioglitazone is the first listed.
NCT01931566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01931566 about?
NCT01931566 is a clinical study titled "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". The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in cognitively-normal parti...
What is the current status of trial NCT01931566?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3,494 participants. The study started on 2013-08-01. Estimated completion is 2018-09-06.
What interventions are being tested in trial NCT01931566?
The interventions under investigation include: Pioglitazone (DRUG), Pioglitazone placebo (DRUG).
Who is sponsoring clinical trial NCT01931566?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01931566's enrollment target sits among peer trials
3,494 70th of 2000 higher than 1,931 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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