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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 0 days
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 2 months2 visits
Treatment ~ 24 months5 visits
Follow Up ~ 0 days0 visits
Screening ~ 2 months
Treatment ~ 24 months
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Free and Cued Selective Reminding Test (FCSRT)
Secondary study objectives
Alzheimer's Disease Cooperative Study Preclinical Alzheimer's Cognitive Composite (PACC-ADCS)
Brain Tau
Brain amyloid
+5 moreTrial 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?
University of RochesterOTHER
869 Previous Clinical Trials
549,436 Total Patients Enrolled
Georgetown UniversityOTHER
350 Previous Clinical Trials
138,851 Total Patients Enrolled
Emory UniversityOTHER
1,701 Previous Clinical Trials
2,604,405 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate in the study if you have a low body mass index, kidney disease with an estimated glomerular filtration rate of less than 45 mL/min, liver disease other than non-fatty liver disease or class III or IV congestive heart failure, moderate to severe depression, dementia, or a history of intolerance to metformin. You also cannot participate if you have had a cerebrovascular accident with residual neurological deficits, neurologic diseases associated with neurological deficits, active cancer or a history of cancer in the last two years (except for certain types of skin cancer), uncontrolled hypertension, or are planning to move to another city or state within the next 24 months. Additionally, you cannot participate if you have a known history of diabetes or if it is discovered during screening using HbA1c criteria. You also cannot participate if you are taking certain medications or treatments, such as aducanumab or amyloid modifying treatments for Alzheimer's disease, or if you are pregnant or planning to become pregnant. Finally, you cannot participate if you are unable to undergo phlebotomy.I have never been diagnosed with Alzheimer's disease.My education level is between 8-15 years.My education level is between 0-7 years and my score is between 3-6.I have been diagnosed with cancer.I have someone close who can discuss my daily activities.You must have some memory problems, as shown by a score of at least 0.5 on a memory test.Your memory and ability to do daily activities are not severely affected by Alzheimer’s disease or other cognitive impairments, as determined by the doctor during the screening visit.I have never taken metformin.I have 16+ years of education and scored ≤ 8.The person has an abnormal memory function that has been 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.
Research Study Groups:
This trial has the following groups:- Group 1: metformin non-users
- Group 2: metformin users
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Months to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 24 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT04098666 — Phase 2 & 3
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