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Active, Not Recruiting

NCT Number: NCT04511416

Preventing Cognitive Decline with Metformin

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cognitive Decline Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Mental Disorders Metabolic Diseases Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Garvan Institute of Medical Research

Sydney, New South Wales, 2010, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Metformin XR, 500-2000mg nocte

Drug

Metformin XR, 500-2000mg nocte

Other names: Placebo

Primary outcomes

  1. changes in memory Z-score

    Time frame: 3 years

    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.

  2. changes in executive function Z-score

    Time frame: 3 years

    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.

Secondary outcomes

  1. changes in processing speed domain Z-score

    Time frame: 3 years

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

  2. changes in language performance domain Z-score

    Time frame: 3 years

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

  3. changes in attention performance domain Z-score

    Time frame: 3 years

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

  4. changes in Cogstate brief battery performance Z-score

    Time frame: 3 years

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

  5. changes in total brain volume (cubic millimetres)

    Time frame: 3 years

    total grey and white matter volume

  6. changes in hippocampal volume (cubic millimetres)

    Time frame: 3 years

    volume of the right and left hippocampal regions of the brain

  7. changes in parahippocampal volume (cubic millimetres)

    Time frame: 3 years

    volume of the right and left parahippocampal regions of the brain

  8. changes in brain white matter hyperintensity number

    Time frame: 3 years

    the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging

  9. changes in cerebral blood flow (mL / 100 g / min)

    Time frame: 3 years

    Cerebral blood flow will be measured using arterial spin labelling

  10. changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)

    Time frame: 3 years

    standardized uptake value ratio of amyloid tracer using positron emission tomography

  11. changes in cognitive performance Z-score using the NIH tool box

    Time frame: 3 years

    The NIH Toolbox currently contains the following cognitive tests: Flanker, Pattern Comparison, Picture Sequence Memory and Dimensional Change Card Sort.

  12. change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging

    Time frame: 3 years

    change blood oxygen-level-dependent time-series signals, measured by functional MRI

  13. changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)

    Time frame: 3 years

    fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)

Sponsors and collaborators

Lead sponsor

Garvan Institute of Medical Research

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

Preventing Cognitive Decline with Metformin:: the MetMemory Study

Acronym: MetMemory

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2020
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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