Alzheimer's Disease Education and Referral Center

Prediction of Mild Cognitive Impairment and Pioglitazone to Delay Its Onset

Prediction of Mild Cognitive Impairment and Pioglitazone to Delay Its Onset

Overall Status: 
Recruiting
Brief Description: 

The purpose of this study is to develop a biomarker that can detect the risk of mild cognitive impairment (MCI) due to Alzheimer's disease in cognitively normal participants who are at high risk. The study will also test whether the drug pioglitazone, an approved treatment for type 2 diabetes, can delay the onset of MCI.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
65 Years
83 Years
Both
Accepts Healthy Volunteers
Inclusion Criteria: 
    • Cognitively normal at screening (Clinical Dementia Rating = 0; at least one memory test above -1.5 standard deviation of the demographically corrected normative mean; Mini-Mental State Examination score of 25 or more
    • Partner able to consent separately on his/her own behalf; provide information on the cognitive, functional, and behavioral status of the participant; and assist with monitoring of study medication, if needed
    • Female participants must agree to take daily supplements of vitamin D (minimum 800 International Units daily) and calcium (minimum 1,000 mg daily) for the duration of the treatment period, unless medically contraindicated
Exclusion Criteria: 
    • Current diagnosis or history of any type of cognitive impairment or dementia
    • Current diagnosis or history of neurological, psychiatric, or any other disorder that significantly affects cognitive performance (for example, mental retardation, major depression, schizophrenia, bipolar disorder)
    • Glycosylated hemoglobin (HbA1c) level of more than 8% at screening or requiring treatment with insulin, triple oral antidiabetic therapy, or a peroxisome proliferator-activated receptor-gamma (PPAR-γ) agonist; must be on stable antidiabetic regimen for at least 3 months prior to enrollment
    • Clinically significant, unstable illness such as hepatic impairment or renal insufficiency; cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders; metabolic disturbance
    • History of drug abuse (defined as any illicit drug use) or alcohol abuse/dependence within 2 years prior to screening
    • Relationship with a testing center employee who is involved in the conduct of this study
    • History of hypersensitivity or allergies to pioglitazone or related compounds
    • Abnormal laboratory test results; unexplained microscopic/macroscopic hematuria on two repeat examinations within 2 weeks; positive for either Hepatitis B surface antigen or anti-hepatitis C virus antibodies
    • Received any investigational compound within 30 days or 5 half-lives prior to screening or currently participating in another study that entails the administration of an investigational or marketed drug, supplement, or intervention, including but not limited to diet, exercise, lifestyle, or invasive procedure
    • Cancer that has been in remission for less than 2 years (basal cell or stage I squamous cell carcinoma of the skin is acceptable); history of bladder cancer not acceptable regardless of remission status
    • Current diagnosis or history of macular edema, degeneration, or any maculopathy
    • If female, history of postmenopausal fractures with no or minimal trauma
    • Current diagnosis or history of congestive heart failure
    • Known genetic risk for Alzheimer's disease
Detailed Description: 

This global study has two goals. One goal is to determine whether a new genetic biomarker can predict which cognitively healthy participants are at risk of developing MCI due to Alzheimer's disease within the next 5 years. The other goal is to evaluate the drug pioglitazone as a way to delay the onset of MCI.

Participants will be assigned to high- or low-risk groups for developing MCI due to Alzheimer's within the next 5 years, based on biomarker results. The high-risk group will be randomly assigned to receive either pioglitazone or a placebo (one tablet once daily). Participants in the low-risk group will be assigned to the placebo. The assignment of each participant to the high- or low-risk group, as well as the participant's treatment, will remain undisclosed to the participants and study doctor during the study.

About 300 participants will participate in an Amyloid-Related Imaging Abnormalities (ARIA) substudy at selected sites. In the ARIA substudy, high-risk participants will be randomized to receive either pioglitazone or a placebo.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4483771, -112.0740373

Site
Phoenix
Arizona
Recruiting
Name:
Phone:

Geolocation is 33.5975393, -112.2718239

Site
Sun City
Arizona
Recruiting
Name:
Phone:

Geolocation is 32.7153292, -117.1572551

Site
San Diego
California
Recruiting
Name:
Phone:

Geolocation is 28.5383355, -81.3792365

Site
Orlando
Florida
Recruiting
Name:
Phone:

Geolocation is 29.1383165, -80.9956105

Site
Port Orange
Florida
Recruiting
Name:
Phone:

Geolocation is 26.1003654, -80.3997748

Site
Weston
Florida
Recruiting
Name:
Phone:

Geolocation is 33.7489954, -84.3879824

Site
Atlanta
Georgia
Recruiting
Name:
Phone:

Geolocation is 41.8781136, -87.6297982

Site
Chicago
Illinois
Not yet recruiting
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
Recruiting
Name:
Phone:

Geolocation is 41.6611277, -91.5301683

Site
Iowa City
Iowa
Recruiting
Name:
Phone:

Geolocation is 38.6270025, -90.1994042

Site
St. Louis
Missouri
Recruiting
Name:
Phone:

Geolocation is 36.255123, -115.2383485

Site
Las Vegas
Nevada
Recruiting
Name:
Phone:

Geolocation is 39.8912248, -74.9218324

Site
Marlton
New Jersey
Recruiting
Name:
Phone:

Geolocation is 40.7143528, -74.0059731

Site
New York
New York
Recruiting
Name:
Phone:

Geolocation is 35.4087517, -80.579511

Site
Concord
North Carolina
Recruiting
Name:
Phone:

Geolocation is 35.9940329, -78.898619

Site
Durham
North Carolina
Recruiting
Name:
Phone:

Geolocation is 41.0814447, -81.5190053

Site
Akron
Ohio
Recruiting
Name:
Phone:

Geolocation is 45.5234515, -122.6762071

Site
Portland
Oregon
Not yet recruiting
Name:
Phone:

Geolocation is 32.7765656, -79.9309216

Site
Charleston
South Carolina
Recruiting
Name:
Phone:

Geolocation is 35.1598334, -89.7615474

Site
Cordova
Tennessee
Recruiting
Name:
Phone:

Geolocation is 29.7601927, -95.3693896

Site
Houston
Texas
Recruiting
Name:
Phone:

Geolocation is 40.7607793, -111.8910474

Site
Salt Lake City
Utah
Recruiting
Name:
Phone:

Geolocation is 43.0972174, -89.5042876

Site
Middleton
Wisconsin
Recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Takeda Pharmaceutical Co.
Collaborator Sponsor: 
Agency
Zinfandel Pharmaceuticals
Facility Investigators: 
NameRoleAffiliation
Medical Director
Study Director
Takeda Pharmaceutical Co.
Study Contact: 
NamePhoneEmail
Takeda Study Registration Call Center
1-800-778-2860
Locations
 
 
ClinicalTrials.gov ID 
NCT01931566 (follow link to view full record on ct.gov in new window)
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 E
Study Start Date: 
August 2013
Study End Date: 
April 2019
Disease Stage: 
Pre-clinical
Enrollment: 
5800