Preventing Cognitive Decline with Metformin (MetMemory)

Garvan Institute of Medical Research

Status and phase: Active, not recruiting; Phase 3

Conditions: Cognitive Decline

Treatments: Drug: Metformin XR, 500-2000mg nocte

Study type: Interventional

Funder types: Other

Identifiers

NCT04511416

1

Details and patient eligibility

About

A randomised control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline and neuroimaging over 3 years.

Full description

A randomised placebo-control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline, neuroimaging and biomarkers over 3 years.

Enrollment: 242 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• overweight or obese (body mass index >25.0 kg/m2, waist: women>80 cm, men>94cm;
• Mild cognitive impairment (Mild Neurocognitive Disorder), based on DSM-5 criteria;
• Fasting blood glucose <7.0 mmol/L and HbA1c <6.5%;
• Able to undertake neurocognitive testing in English.
• Not participating in another trial of drugs or lifestyle modification to reduce cognitive decline.

Exclusion criteria

• Life-threatening illnesses to preclude participation in a 3-year study;
• Contraindications to the use of metformin (severe heart failure or eGFR <40).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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242 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Metformin

Treatment:

Drug: Metformin XR, 500-2000mg nocte

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Metformin XR, 500-2000mg nocte