Preventing Cognitive Decline With Metformin (MetMemory)

June 22, 2022 updated by: Garvan Institute of Medical Research

Preventing Cognitive Decline With Metformin:: The MetMemory Study

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Interventional

Enrollment (Anticipated)

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Sydney, Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Not yet recruiting
        • professor Katherine Samaras
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
anti diabetic medication
Active Comparator: Intervention
Metformin
anti diabetic medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years
changes in language performance domain Z-score
Time Frame: 3 years
language performance domain measured by the Category Fluency (Animals) neuropsychological test
3 years
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
3 years
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)
3 years
changes in total brain volume (cubic millimetres)
Time Frame: 3 years
total grey and white matter volume
3 years
changes in hippocampal volume (cubic millimetres)
Time Frame: 3 years
volume of the right and left hippocampal regions of the brain
3 years
changes in parahippocampal volume (cubic millimetres)
Time Frame: 3 years
volume of the right and left parahippocampal regions of the brain
3 years
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
3 years
changes in cerebral blood flow (mL / 100 g / min)
Time Frame: 3 years
Cerebral blood flow will be measured using arterial spin labelling
3 years
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
3 years
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.
3 years
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
3 years
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)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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