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Biguanide

MAP (MAP Trial)

Phase 2 & 3
Recruiting
Led By Jose A Luchsinger, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of aMCI: Participants must have subjective memory concern reported by participant, study partner, or clinician. A mini-mental state exam between ≥ 22 for subjects with more than 8 years of education. For subjects with less than 8 years of education, a MMSE ≥ 20 will be allowed. Clinical Dementia Rating 0.5. The memory box score must be at least 0.5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale-Revised. For early MCI: 9-11 for 16 or more years of education, 5-9 for 8-15 years of education, 3-6 for 0-7 years of education. For late MCI: ≤ 8 for 16 or more years of education, ≤ 4 for 8-15 years of education, ≤ 2 for 0-7 years of education. Age range: 55 years to 90 years. Sex distribution: all eligible men and women will be included and no one will be excluded because of gender. Languages: fluent in English or Spanish. We have reliable, well-validated Spanish tests for all outcome measures. Participants without a known history of diabetes. If diabetes is diagnosed during screening (hemoglobin A1c of 6.5 % or greater) they will also be excluded. The main justification for this exclusion is the potential for these participants to be placed on other diabetes medications that may confound our study. General cognition and functional performance such that a diagnosis of dementia cannot be made at the time of screening based on DSM-V criteria. Vision and hearing must be sufficient for compliance with testing procedures. Must have an informant to come to all appointments or be available by telephone at follow-up visits.
Have you NEVER taken metformin before?
Timeline
Screening 2 months
Treatment 24 months
Follow Up 18 months
Awards & highlights

MAP Trial Summary

This trial will test whether long-acting metformin can prevent or delay cognitive decline in people with early and late Alzheimer's disease.

Who is the study for?
This trial is for men and women aged 55-90 with early or late mild cognitive impairment (MCI), specifically those who have memory concerns but not a diagnosis of Alzheimer's. Participants must not have diabetes, be overweight or obese, and able to attend study visits or available by phone. They should also have sufficient vision and hearing for tests.Check my eligibility
What is being tested?
The MAP trial is testing extended-release metformin against a placebo in individuals without diabetes who are at risk for Alzheimer's. Over 18 months, participants will take increasing doses of the drug/placebo while undergoing neuropsychological tests, physical exams, brain scans, and bloodwork to monitor changes in memory function.See study design
What are the potential side effects?
While the trial doesn't list specific side effects of metformin for this population, common ones include digestive issues like nausea or diarrhea, potential vitamin B12 deficiency with long-term use, and very rarely a serious condition called lactic acidosis.

MAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never taken metformin.
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I have never been diagnosed with Alzheimer's disease.
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I have someone close who can discuss my daily activities.

MAP Trial Timeline

Screening ~ 2 months
Treatment ~ 24 months
Follow Up ~18 months
This trial's timeline: 2 months for screening, 24 months for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Free and Cued Selective Reminding Test (FCSRT)
Secondary outcome measures
Alzheimer's Disease Cooperative Study Preclinical Alzheimer's Cognitive Composite (PACC-ADCS)
Brain Tau
Brain amyloid
+5 more

MAP Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: metformin usersExperimental Treatment1 Intervention
Extended release metformin 500 mg tablets up to 2,000 mg (4 tablets) a day once at night. The maximum dose will be attempted during a titration period in the first month of the study.
Group II: metformin non-usersPlacebo Group1 Intervention
Placebo tablets identical to extended release metformin 500 mg tablets up to 4 tablets a day once at night. The maximum dose will be attempted during a titration period in the first month of the study.

Find a Location

Who is running the clinical trial?

Emory UniversityOTHER
1,634 Previous Clinical Trials
2,559,847 Total Patients Enrolled
University of RochesterOTHER
834 Previous Clinical Trials
517,966 Total Patients Enrolled
Georgetown UniversityOTHER
343 Previous Clinical Trials
136,176 Total Patients Enrolled

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT04098666 — Phase 2 & 3
Mild Cognitive Impairment Research Study Groups: metformin non-users, metformin users
Mild Cognitive Impairment Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04098666 — Phase 2 & 3
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098666 — Phase 2 & 3
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT04098666 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this clinical trial consider applicants who are over 18 years old?

"The age limit for this study is 55-90 years old."

Answered by AI

What is the most common ailment that metformin is used to address?

"Exercise is most commonly treated with metformin. Metformin is also effective at treating other conditions including type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Are people still able to sign up for this experiment?

"The trial, which is currently looking for participants, was originally posted on March 22nd 2021. The listing was updated on October 31st of this year."

Answered by AI

Is there precedent for this proposed metformin study?

"There are currently 45 Phase 3 trials and 180 active studies investigating the use of metformin. Many of these medical investigations are based in Pittsburgh, but there are 1952 locations across the globe conducting similar research."

Answered by AI

How many study participants are needed for this clinical trial?

"In order for this trial to be completed, 370 eligible individuals must enroll. Those who wish to participate can do so at Columbia University Medical Center or New york University Langone Medical Center."

Answered by AI

Is this a widespread or localized study?

"To limit the inconvenience of travel, please enroll at the location nearest to you from the 10 sites currently recruiting patients. These locations include New york, Chicago and Boston among others."

Answered by AI

Could I potentially qualify to participate in this research?

"Up to 370 individuals with mci will be enrolled in this study. These participants must be between 55 and 90 years old and meet the following requirements: Abnormal memory function as documented by a score within the education-adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale-Revised., Clinical Dementia Rating 0.5. The memory box score must be at least 0.5., General cognition and functional performance that is preserved enough such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of screening visit"

Answered by AI

Who else is applying?

What state do they live in?
Washington
Illinois
New York
Other
How old are they?
18 - 65
65+
What site did they apply to?
University of Miami
Boston University
Rush University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0

What questions have other patients asked about this trial?

Are you paid for this study? How long do screening test take ? How long does the screening visit take?
PatientReceived 1 prior treatment
How long is the study and how many days?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I'm concerned with my memory. i DONT QUALIFY FOR MANY STUDIES, DUE TO AGE.
PatientReceived no prior treatments
Does not qualify for other studies.He is 88. Just been told about my condition about year ago.
PatientReceived 2+ prior treatments
Ive noticed an increas in memory loss over the past.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Boston University: < 24 hours
  2. Wake Forest University Health Sciences: < 24 hours
  3. Georgetown University: < 24 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
~130 spots leftby Mar 2026