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Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone

Clinical Trial Title: 
Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone
Clinical Trial Protocol ID: 
12011901
Clinical Trial Investigator Name: 
Raj C. Shah, MD
Clinical Trial Protocol Description: 

The purpose of this five-year study is to qualify the biomarker risk algorithm for prognosis of the risk of developing MCI due to AD, and evaluate the efficacy of pioglitazone to delay the onset of MCI due to AD in cognitively normal persons.

Subjects will receive blinded study treatment taken once daily for study duration. Subjects will undergo cognitive testing and physical examinations, ECGs and blood draws throughout the course of the study. Biannual clinic visits and telephone visits will be conducted.

At Rush University Medical Center we expect to recruit approximately 100 patients. The treatment will be assigned randomly.

Clinical Trial Eligibility Criteria: 

In order to participate you must:

  • Be 65 to 83 years of age
  • Have a reliable study partner
  • If female, be willing and able to take daily vitamin D (≥ 800 IU) and calcium (≥ 1000mg) supplements, unless medically contraindicated

You will be excluded from the study if you:

  • Have a diagnosis of other neurological/psychiatric disease(s), or  serious or unstable illnesses
  • Have a history of drug or alcohol abuse/dependence within the past two years

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Alzheimer’s Disease and Related Dementias
Contact Phone: 
(312) 563-4111
Contact Name: 
Karoll Meza