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Preventing Cognitive Decline With Metformin (MetMemory)

Primary Purpose

Cognitive Decline

Status
Recruiting
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Metformin XR, 500-2000mg nocte
Sponsored by
Garvan Institute of Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Decline focused on measuring cognitive decline, dementia, cerebrovascular disease, insulin resistance, neurodegeneration, inflammation, diabetes

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Professor Katherine Samaras
  • Garvan Institute to Medical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Metformin

Placebo

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

changes in processing speed domain Z-score
processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B
changes in language performance domain Z-score
language performance domain measured by the Category Fluency (Animals) neuropsychological test
changes in attention performance domain Z-score
attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test
changes in Cogstate brief battery performance Z-score
computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)
changes in total brain volume (cubic millimetres)
total grey and white matter volume
changes in hippocampal volume (cubic millimetres)
volume of the right and left hippocampal regions of the brain
changes in parahippocampal volume (cubic millimetres)
volume of the right and left parahippocampal regions of the brain
changes in brain white matter hyperintensity number
the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging
changes in cerebral blood flow (mL / 100 g / min)
Cerebral blood flow will be measured using arterial spin labelling
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
standardized uptake value ratio of amyloid tracer using positron emission tomography
changes in cognitive performance Z-score using the NIH tool box
The NIH Toolbox currently contains the following cognitive tests: Flanker, Pattern Comparison, Picture Sequence Memory and Dimensional Change Card Sort.
change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging
change blood oxygen-level-dependent time-series signals, measured by functional MRI
changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)

Full Information

First Posted
July 2, 2020
Last Updated
June 22, 2022
Sponsor
Garvan Institute of Medical Research
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04511416
Brief Title
Preventing Cognitive Decline With Metformin
Acronym
MetMemory
Official Title
Preventing Cognitive Decline With Metformin:: The MetMemory Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Garvan Institute of Medical Research
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline
Keywords
cognitive decline, dementia, cerebrovascular disease, insulin resistance, neurodegeneration, inflammation, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomised placebo controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Metformin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Metformin XR, 500-2000mg nocte
Intervention Description
anti diabetic medication
Primary Outcome Measure Information:
Title
changes in memory Z-score
Description
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
Title
changes in executive function Z-score
Description
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 Outcome Measure Information:
Title
changes in processing speed domain Z-score
Description
processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B
Time Frame
3 years
Title
changes in language performance domain Z-score
Description
language performance domain measured by the Category Fluency (Animals) neuropsychological test
Time Frame
3 years
Title
changes in attention performance domain Z-score
Description
attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test
Time Frame
3 years
Title
changes in Cogstate brief battery performance Z-score
Description
computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)
Time Frame
3 years
Title
changes in total brain volume (cubic millimetres)
Description
total grey and white matter volume
Time Frame
3 years
Title
changes in hippocampal volume (cubic millimetres)
Description
volume of the right and left hippocampal regions of the brain
Time Frame
3 years
Title
changes in parahippocampal volume (cubic millimetres)
Description
volume of the right and left parahippocampal regions of the brain
Time Frame
3 years
Title
changes in brain white matter hyperintensity number
Description
the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging
Time Frame
3 years
Title
changes in cerebral blood flow (mL / 100 g / min)
Description
Cerebral blood flow will be measured using arterial spin labelling
Time Frame
3 years
Title
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
Description
standardized uptake value ratio of amyloid tracer using positron emission tomography
Time Frame
3 years
Title
changes in cognitive performance Z-score using the NIH tool box
Description
The NIH Toolbox currently contains the following cognitive tests: Flanker, Pattern Comparison, Picture Sequence Memory and Dimensional Change Card Sort.
Time Frame
3 years
Title
change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging
Description
change blood oxygen-level-dependent time-series signals, measured by functional MRI
Time Frame
3 years
Title
changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
Description
fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Samaras, MD, PhD
Phone
61292958312
Email
k.samaras@garvan.org.au
Facility Information:
Facility Name
Professor Katherine Samaras
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Samaras, MBBS FRACP PhD
Email
k.samaras@garvan.org.au
Facility Name
Garvan Institute to Medical Research
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Samaras
Email
k.samaras@garvan.org.au

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Cognitive Decline With Metformin

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