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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 Sep 5, 2026, 8:49 AM 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
Jul 31, 2013
Primary completion
Jul 23, 2018
Completion
Sep 5, 2018
Last update posted
Sep 15, 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 15, 2019 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01931566 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →