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Mild Cognitive Impairment / extended release metformin / Placebo oral tablet · Phase 2/3 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 2/3 RCT examining extended-release metformin versus placebo in 326 adults with mild cognitive impairment, with an 18-month primary endpoint of cognitive change measured by FCSRT and secondary endpoints including amyloid and tau PET imaging, MRI neurodegeneration markers, and plasma AD biomarkers. No results have been posted to the registry; the study status is active but not yet recruiting.
Phase 2/3, Interventional, Randomized, Parallel, Quadruple masking, Prevention purpose. Mild Cognitive Impairment; age from 55 Years; to 90 Years; accepts healthy volunteers. Intervention: metformin users. Compared with: metformin non-users — Placebo Comparator. n = 326. 22 sites: United States.
This is a registered Phase 2/3 RCT examining extended-release metformin versus placebo in 326 adults with mild cognitive impairment, with an 18-month primary endpoint of cognitive change measured by FCSRT and secondary endpoints including amyloid and tau PET imaging, MRI neurodegeneration markers, and plasma AD biomarkers. No results have been posted to the registry; the study status is active but not yet recruiting.
Effect sizes, safety data, and outcome findings are not yet available.
The source did not state who this applies to in practice.
This is a registered Phase 2/3 RCT design with no results reported; it describes a planned intervention study in mild cognitive impairment with cognitive and biomarker endpoints, currently active but not yet recruiting.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04098666). This is a study registration, not published results. Lead sponsor: Columbia University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 326 participants (ACTUAL). Conditions: Mild Cognitive Impairment. Interventions: DRUG: Placebo oral tablet; DRUG: extended release metformin. Primary outcome measures: Free and Cued Selective Reminding Test (FCSRT) , 18 months. Brief summary: 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.
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