Cognitive DeclinePhase 3MetMemoryNCT04511416
Preventing Cognitive Decline with Metformin
A Phase 3 study testing Metformin XR, 500-2000mg nocte in people with Cognitive Decline, run by Garvan Institute of Medical Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Metformin XR, 500-2000mg nocte
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Jul 2022to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Life-threatening illnesses to preclude participation in a 3-year study;
- Contraindications to the use of metformin (severe heart failure or eGFR <40).
Trial locations and contacts
1 site in 1 country.
Australia1 site
Garvan Institute of Medical Research
Sydney, New South Wales, 2010
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Decline
- Being tested
- Metformin XR, 500-2000mg nocte
- Keywords
- cognitive decline, dementia, cerebrovascular disease, insulin resistance, neurodegeneration, inflammation, diabetes
- Medical subject headings
- Cognitive Dysfunction, Dementia, Cerebrovascular Disorders, Insulin Resistance, Nerve Degeneration, Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin XR, 500-2000mg nocteDrug
Also called Placebo
Metformin XR, 500-2000mg nocte
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Metformin Receives: Drug: Metformin XR, 500-2000mg nocte |
| Placebo | Placebo comparator | Placebo Receives: Drug: Metformin XR, 500-2000mg nocte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Secondary outcomes (13)
changes in processing speed domain Z-score
processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B
Measured: 3 years
changes in language performance domain Z-score
language performance domain measured by the Category Fluency (Animals) neuropsychological test
Measured: 3 years
changes in attention performance domain Z-score
attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test
Measured: 3 years
changes in Cogstate brief battery performance Z-score
computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)
Measured: 3 years
changes in total brain volume (cubic millimetres)
total grey and white matter volume
Measured: 3 years
changes in hippocampal volume (cubic millimetres)
volume of the right and left hippocampal regions of the brain
Measured: 3 years
changes in parahippocampal volume (cubic millimetres)
volume of the right and left parahippocampal regions of the brain
Measured: 3 years
changes in brain white matter hyperintensity number
the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging
Measured: 3 years
changes in cerebral blood flow (mL / 100 g / min)
Cerebral blood flow will be measured using arterial spin labelling
Measured: 3 years
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
standardized uptake value ratio of amyloid tracer using positron emission tomography
Measured: 3 years
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.
Measured: 3 years
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
Measured: 3 years
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start15 Jul 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garvan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511416
- Sponsor's protocol ID
- 1
- Acronym
- MetMemory
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cognitive Decline with Metformin:: the MetMemory Study
- ClinicalTrials.gov ID
- NCT04511416
- Acronym / sponsor ID
- MetMemory / 1
- Conditions
- Cognitive Decline
- Keywords
- cognitive decline, dementia, cerebrovascular disease, insulin resistance, neurodegeneration, inflammation, diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Garvan Institute of Medical ResearchUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Metformin XR, 500-2000mg nocteMetformin |
| Placebo | Placebo comparator | Drug: Metformin XR, 500-2000mg noctePlacebo |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Life-threatening illnesses to preclude participation in a 3-year study;
- Contraindications to the use of metformin (severe heart failure or eGFR <40).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin XR, 500-2000mg nocteAlso: PlaceboMetformin XR, 500-2000mg nocte | Drug | Intervention, Placebo |
Primary outcome
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.
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.
13 secondary outcomes
changes in processing speed domain Z-score
Time frame: 3 years
changes in language performance domain Z-score
Time frame: 3 years
changes in attention performance domain Z-score
Time frame: 3 years
changes in Cogstate brief battery performance Z-score
Time frame: 3 years
changes in total brain volume (cubic millimetres)
Time frame: 3 years
changes in hippocampal volume (cubic millimetres)
Time frame: 3 years
changes in parahippocampal volume (cubic millimetres)
Time frame: 3 years
changes in brain white matter hyperintensity number
Time frame: 3 years
changes in cerebral blood flow (mL / 100 g / min)
Time frame: 3 years
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
Time frame: 3 years
changes in cognitive performance Z-score using the NIH tool box
Time frame: 3 years
change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging
Time frame: 3 years
changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin XR, 500-2000mg nocte in people with Cognitive Decline, run by Garvan Institute of Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in memory Z-score (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.