Metformin for Alzheimer's Dementia Prevention

What Is This Study About?

This study will test the effects of metformin, an FDA-approved medication to treat diabetes, on memory and other indicators of Alzheimer's disease in older adults who are overweight or obese and have mild cognitive impairment but do not have diabetes. Participants will be randomly assigned to take a placebo or extended-release metformin medication, by mouth, daily for two years. Researchers will conduct a physical exam and neuropsychological testing at the start of the study and every six months. Approximately half of participants will undergo MRI and amyloid PET brain scans at the start and end of the study.

Do I Qualify To Participate in This Study?

Must have:

• Diagnosis of amnestic mild cognitive impairment
• Fluency in English or Spanish
• No known history of diabetes
• No evidence of dementia based on general cognition and functional performance
• Vision and hearing sufficient to complete testing procedures
• Study partner to come to all appointments or be available by telephone at follow-up visits
• Participants who have a condition that prevents them from safely having an MRI (e.g., metal implants or devices, morbid obesity, claustrophobia, epilepsy, etc.) will still be able to participate in the study but will not undergo MRI procedure

Must NOT have:

• Current use of metformin
• History of intolerance to metformin
• Evidence of kidney or liver disease, congestive heart failure, and/or alcohol abuse
• History of cerebrovascular event (e.g., stroke) that resulted in neurological impairment
• Body mass index < 20
• Diagnosis of dementia, neurological diseases, or neuropsychiatric illness including depression, bipolar disorder, and schizophrenia
• Alcohol or substance abuse within past six months.
• Currently taking medications that may cause memory problems, including > 2mg daily of lorazepam or regular use of prescription narcotics
• Uncontrolled high blood pressure
• Cancer within two years, except squamous or basal cell carcinoma of the skin
• Known history of diabetes
• Currently taking aducanumab or any other amyloid-modifying treatment for Alzheimer's
• Female participants must not be pregnant or plan to become pregnant

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

District of Columbia
Georgetown University Washington, DC 20007 Recruiting Katie Seidenberg 202-687-5338 ks1891@georgetown.edu
Florida
University of Miami Miami, FL 33136 Recruiting Barry Baumel, MD
Illinois
Rush University Medical Center Chicago, IL 60612 Recruiting Zoe Arvanitakis, MD
Massachusetts
Boston University Boston, MA 02118 Recruiting Alexa Puleio puleioa@bu.edu
Columbia University Medical Center New York, NY 10032 Recruiting Juan Vassallo 646-946-9158 jv2772@cumc.columbia.edu
SUNY Upstate Medical University Syracuse, NY 13210 Recruiting Kevin Hanretty, MS 315-464-8373 HanrettK@upstate.edu
North Carolina
Wake Forest University Health Sciences Winston-Salem, NC 27157 Recruiting Mikell White 336-414-0129 miwhite@wakehealth.edu
Texas
University of Texas - Southwestern Medical Center Dallas, TX 75390 Not yet recruiting Luann Tunell 214-645-9018 Luann.Tunell@UTSouthwestern.edu
The University of Texas Health Science Center San Antonio San Antonio, TX 78229 Recruiting Daisy Castillo 210-617-5300 castillod5@uthscsa.edu
Virginia
Eastern Virginia Medical School Norfolk, VA 23507 Not yet recruiting Amber Ingram, MS 757-446-8485 IngramAM@evms.edu
Washington
University of Washington Seattle, WA 98104 Recruiting Angela Hanson, MD

Who Sponsors This Study?

Lead: Columbia University

Collaborator Sponsor

• Johns Hopkins University
• National Institute on Aging (NIA)
• University of Rochester
• University of Iowa
• Weill Medical College of Cornell University
• Boston University
• Wake Forest University
• Rush University
• Pennington Biomedical Research Center
• University of Miami
• Emory University
• Georgetown University
• NYU Langone Health
• University of California, Berkeley

Source: ClinicalTrials.gov ID: NCT04098666