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Find more clinical trials

Metformin for Alzheimer's Dementia Prevention

Start: March 22, 2021
End: April 2026
Enrollment: 370

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?

Minimum Age: 55 Years

Maximum Age: 90 Years

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.

Study Contact
José A Luchsinger, MD
Sam Cammack, MA, MPH

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

District of Columbia
Georgetown University
Washington, DC 20007
Katie Seidenberg
University of Miami
Miami, FL 33136
Barry Baumel, MD
Rush University Medical Center
Chicago, IL 60612
Zoe Arvanitakis, MD
Boston University
Boston, MA 02118
Alexa Puleio
Columbia University Medical Center
New York, NY 10032
Juan Vassallo
SUNY Upstate Medical University
Syracuse, NY 13210
Kevin Hanretty, MS
North Carolina
Wake Forest University Health Sciences
Winston-Salem, NC 27157
Mikell White
University of Texas - Southwestern Medical Center
Dallas, TX 75390
Not yet recruiting
Luann Tunell
The University of Texas Health Science Center San Antonio
San Antonio, TX 78229
Daisy Castillo
Eastern Virginia Medical School
Norfolk, VA 23507
Not yet recruiting
Amber Ingram, MS
University of Washington
Seattle, WA 98104
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: ID: NCT04098666

An official website of the U.S. government, managed by the National Institutes on Aging at the National Institutes of Health