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Preventing Cognitive Decline With Metformin (MetMemory)

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ClinicalTrials.gov Identifier: NCT04511416
Recruitment Status : Not yet recruiting
First Posted : August 13, 2020
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Garvan Institute of Medical Research

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Drug: Metformin XR, 500-2000mg nocte Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preventing Cognitive Decline With Metformin:: The MetMemory Study
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention
Metformin
 Drug: Metformin XR, 500-2000mg nocte
anti diabetic medication
Placebo Comparator: Placebo
Placebo
 Drug: Metformin XR, 500-2000mg nocte
anti diabetic medication


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511416


Contacts
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Contact: Katherine Samaras, MD, PhD 61292958312 k.samaras@garvan.org.au

Locations
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Australia, New South Wales
Professor Katherine Samaras
Sydney, New South Wales, Australia, 2010
Contact: Katherine Samaras, MBBS FRACP PhD       k.samaras@garvan.org.au   
Australia
Garvan Institute to Medical Research
Sydney, Australia
Sponsors and Collaborators
Garvan Institute of Medical Research
National Health and Medical Research Council, Australia
More Information
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Responsible Party: Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT04511416    
Other Study ID Numbers: 1
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Garvan Institute of Medical Research:
cognitive decline
dementia
cerebrovascular disease
insulin resistance
 neurodegeneration
inflammation
diabetes
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs