Find-A-Study

Metformin in Alzheimer's dementia Prevention (MAP)

Purpose

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

Study Contact

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

Sandra Idar
(210) 450-0568
idars@uthscsa.edu

Principal Investigator
Sara Espinoza

Sandra Idar
(210) 450-0568
idars@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

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

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.