Preventing Cognitive Decline with Metformin

Phase 3Active Not RecruitingNCT04511416

Garvan Institute of Medical Research242 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

242

Conditions

Cognitive Decline

Interventions

Metformin XR, 500-2000mg nocteDRUG

Metformin XR, 500-2000mg nocte

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Garvan Institute of Medical Research

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

changes in memory Z-score

memory domain Z-score, derived from the following neuropsychological tests: i. Rey Auditory Verbal Learning Test (RAVLT); ii. Total Learning and Delayed recall; iii. the Logical Memory Story A- Immediate Recall; and iv. Delayed Recall tests.

Time frame: 3 years

changes in executive function Z-score

executive function domain Z-score, derived from the following neuropsychological tests: i. Alphabet test; ii. D-KEFS Stroop; iii. Trail Making Test Part B; iv. Weschler Adult Intelligence Scale-IV (WAIS-IV) Digit Span Backward test.

Time frame: 3 years

Secondary Outcomes

changes in processing speed domain Z-score

processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B

Time frame: 3 years

changes in language performance domain Z-score

language performance domain measured by the Category Fluency (Animals) neuropsychological test

Time frame: 3 years

changes in attention performance domain Z-score

attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test

Time frame: 3 years

changes in Cogstate brief battery performance Z-score

computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)

Time frame: 3 years

changes in total brain volume (cubic millimetres)

total grey and white matter volume

Data from ClinicalTrials.gov

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