Purpose

Research study looking at whether metformin can help prevent memory decline for people with mild memory concerns.

Category

IRB Number
20220365HU
NCT Number
NCT04098666
Sponsor
Columbia University -



Study Contact

Principal Investigator
Sara Espinoza

Daisy Castillo
210-617-5311
castillod5@uthscsa.edu

Alice Conde
210-617-5300
condea@uthscsa.edu



Eligibility

Eligible Ages
55-90
Eligible Genders
Male and Females
Accepts Healthy Volunteers
Yes

Inclusion Criteria

    • You or your loved ones have noticed some changes in your memory, and
    • You are not already being treated for diabetes or dementia

Exclusion Criteria

    • Live in a nursing home or assisted living facility
    • Have diabetes
    • Have dementia
    • Have a chronic or disabling disease
    • You are using metformin or known intolerance to metformin

Study Design

Condition or disease   Intervention/treatment Phase 
Mild Cognitive Impairment                                         

Drug: Placebo oral tablet        

Drug: extended release metformin                                          

Phase 2

Phase 3                                                                                                 

Description: 

MAP is a multisite research study looking at an existing drug used for diabetes prevention. The study tests if this drug can help prevent a decline in memory and thinking abilities for people with mild memory problems. It is a randomized study in which you will take either metformin (Glucophage® XR) or a placebo.

Duration of the Study:

This is a two-year study with approximately five (5) study visits to the local study site. After screening for eligibility and consent, participants will have a baseline visit. After baseline visit, Metformin (or matching placebo) will be given to participants starting at 500 mg and incresed by 500 mg every 10 days until reaching 2,000 mg a day, as recommended by the manufacturers. Participants will be seen every 6 months thereafter for study assessments/procedures.

Study Procedures:

  • Medical history
  • Physical examination/assessment
  • Blood tests
  • Memory and thinking activities
  • Monthly check-in calls between visits
  • MRI of your brain (optional)

Arm Groups

Arm Intervention/treatment 
Experimental: metformin users

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.

Drug: extended release metformin

Metformin extended release 500 mg tablets, up to 4 tablets a day

Other Name: Metformin

Placebo Comparator: metformin non-users

Placebo tablets identical to dxtended 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.

Drug: Placebo oral tablet

Placebo tablet identical to metformin, up to 4 tablets a day

Other Name: Placebo