- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511416
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
Intervention / Treatment
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
- Name: Katherine Samaras, MD, PhD
- Phone Number: 61292958312
- Email: k.samaras@garvan.org.au
Study Locations
-
-
-
Sydney, Australia
- Recruiting
- Garvan Institute to Medical Research
-
Contact:
- Katherine Samaras
- Email: k.samaras@garvan.org.au
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2010
- Not yet recruiting
- professor Katherine Samaras
-
Contact:
- Katherine Samaras, MBBS FRACP PhD
- Email: k.samaras@garvan.org.au
-
-
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.
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
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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