Metformin in Alzheimer's Dementia Prevention (NCT04098666)
🩺 Plain-English Summary (8th-Grade Level)
MAP will be a multi-center phase 2/3 1:1 randomized controlled trial (RCT) of long-acting metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 18 months and have 4 visits: baseline, 6-months, 12-months, and 18-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 18. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT. The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary endpoints are 1) changes in global cognitive performance, measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC); 2) changes in neurodegeneration, ascertained as cortical thickness in areas affected by AD on brain MRI; 3) changes in cerebrovascular disease, ascertained as white matter hyperintensities (WMH) volume on brain MRI; 4) Changes in whole brain amyloid ß (Aß) SUVR and in incident amyloid positivity; 5) Changes in tau SUVR in a composite brain region comprising medial and inferolateral temporal cortex; 6) Changes in plasma AD biomarkers. The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono.
Who can join: Review the eligibility criteria below.
Location: University of California - Irvine — Irvine, California
Age range: 55 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- University of California - Irvine — Irvine, California
- Stanford University — Palo Alto, California
- Georgetown University — Washington D.C., District of Columbia
- University of Miami — Miami, Florida
- Emory University — Atlanta, Georgia
- Rush University Medical Center — Chicago, Illinois
- University of Kansas Medical Center — Wichita, Kansas
- Pennington Biomedical Research Center — Baton Rouge, Louisiana
- Boston University — Boston, Massachusetts
- University of New Mexico — Albuquerque, New Mexico
- University at Buffalo — Buffalo, New York
- New York University Langone Medical Center — New York, New York
- Columbia University Medical Center — New York, New York
- Cornell University — New York, New York
- SUNY Upstate Medical University — Syracuse, New York
- Wake Forest University Health Sciences — Winston-Salem, North Carolina
- University of Cincinnati — Cincinnati, Ohio
- University of Texas - Southwestern Medical Center — Dallas, Texas
- The University of Texas Health Science Center San Antonio — San Antonio, Texas
- Eastern Virginia Medical School — Norfolk, Virginia
- University of Washington — Seattle, Washington
- Medical College of Wisconsin — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.