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Terminated Phase 3 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01931566

Public ClinicalTrials.gov record NCT01931566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment Due to Alzheimer's Disease (MCI Due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI Due to AD in Cognitively Normal Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01931566
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
3,494 participants

Conditions and interventions

Eligibility (public fields only)

Age range
65 Years to 83 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 1, 2013 (Actual)
Primary completion
Jul 24, 2018 (Actual)
Completion
Sep 6, 2018 (Actual)
Last update posted
Sep 16, 2019

2013 – 2018

United States locations

U.S. sites
34
U.S. states
19
U.S. cities
34
Facility City State ZIP Site status
Not listed Phoenix Arizona — —
Not listed Sun City Arizona — —
Not listed Long Beach California — —
Not listed San Diego California — —
Not listed San Francisco California — —
Not listed Delray Beach Florida — —
Not listed Fort Myers Florida — —
Not listed Lady Lake Florida — —
Not listed Lake Worth Florida — —
Not listed Merritt Island Florida — —
Not listed Orlando Florida — —
Not listed Port Orange Florida — —
Not listed St. Petersburg Florida — —
Not listed Weston Florida — —
Not listed Atlanta Georgia — —
Not listed Decatur Georgia — —
Not listed Chicago Illinois — —
Not listed Elk Grove Illinois — —
Not listed Elk Grove Village Illinois — —
Not listed Iowa City Iowa — —
Not listed Farmington Hills Michigan — —
Not listed St Louis Missouri — —
Not listed Las Vegas Nevada — —
Not listed Marlton New Jersey — —
Not listed New York New York — —
Not listed Concord North Carolina — —
Not listed Durham North Carolina — —
Not listed Akron Ohio — —
Not listed Portland Oregon — —
Not listed Charleston South Carolina — —
Not listed Cordova Tennessee — —
Not listed Houston Texas — —
Not listed Salt Lake City Utah — —
Not listed Middleton Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01931566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 16, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01931566 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →