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NCT04098666 · ClinicalTrials.gov registry record · Phase 2

Metformin in Alzheimer's Dementia Prevention

A Phase 2 study of Mild Cognitive Impairment, sponsored by Columbia University.

Active
Registry status
Phase 2
Development phase
326
Enrollment target
20
Study locations

NCT04098666 is a Phase 2 study of Mild Cognitive Impairment that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 326 participants, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04098666, a Phase 2 study of Mild Cognitive Impairment, is active but no longer recruiting, sponsored by Columbia University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
326 participants
Enrollment target
20
Study locations

Study Summary

MAP will be a multisite phase II/III 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 an

Conditions Studied

Mild Cognitive Impairment

Interventions

  • DRUG Placebo oral tablet
  • DRUG extended release metformin

Study Locations (20)

New York

  • University at Buffalo - Buffalo
  • New York University Langone Medical Center - New York
  • Columbia University Medical Center - New York
  • Cornell University - New York
  • SUNY Upstate Medical University - Syracuse

California

  • University of California - Irvine - Irvine
  • Stanford University - Palo Alto

Texas

  • University of Texas - Southwestern Medical Center - Dallas
  • The University of Texas Health Science Center San Antonio - San Antonio

District of Columbia

  • Georgetown University - Washington D.C.

Florida

  • University of Miami - Miami

Georgia

  • Emory University - Atlanta

Illinois

  • Rush University Medical Center - Chicago

Kansas

  • University of Kansas Medical Center - Wichita

Trial Details

FieldValue
Enrollment Target 326 participants
Start Date 2021-03-22
Est. Completion 2027-04-30
Phase Phase 2

Sponsor

Columbia University

958 total trials

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What the Registry Record Tells You About NCT04098666

The ClinicalTrials.gov registry entry for NCT04098666 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (74% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.

NCT04098666 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Texas.

Frequently Asked Questions

What is clinical trial NCT04098666 about?

NCT04098666 is a clinical study titled "Metformin in Alzheimer's Dementia Prevention". MAP will be a multisite phase II/III 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 w...

What is the current status of trial NCT04098666?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 326 participants. The study started on 2021-03-22. Estimated completion is 2027-04-30.

What conditions does trial NCT04098666 study?

This clinical trial studies the following conditions: Mild Cognitive Impairment.

What interventions are being tested in trial NCT04098666?

The interventions under investigation include: Placebo oral tablet (DRUG), extended release metformin (DRUG).

Who is sponsoring clinical trial NCT04098666?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04098666 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.