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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04511416




Registration number
NCT04511416
Ethics application status
Date submitted
2/07/2020
Date registered
13/08/2020
Date last updated
5/02/2021

Titles & IDs
Public title
Preventing Cognitive Decline With Metformin
Scientific title
Preventing Cognitive Decline With Metformin:: The MetMemory Study
Secondary ID [1] 0 0
1
Universal Trial Number (UTN)
Trial acronym
MetMemory
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metformin XR, 500-2000mg nocte

Active Comparator: Intervention - Metformin

Placebo Comparator: Placebo - Placebo


Treatment: Drugs: Metformin XR, 500-2000mg nocte
anti diabetic medication

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
changes in processing speed domain Z-score - processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
changes in language performance domain Z-score - language performance domain measured by the Category Fluency (Animals) neuropsychological test
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
changes in attention performance domain Z-score - attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
changes in Cogstate brief battery performance Z-score - computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
changes in total brain volume (cubic millimetres) - total grey and white matter volume
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
changes in hippocampal volume (cubic millimetres) - volume of the right and left hippocampal regions of the brain
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
changes in parahippocampal volume (cubic millimetres) - volume of the right and left parahippocampal regions of the brain
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
changes in brain white matter hyperintensity number - the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
changes in cerebral blood flow (mL / 100 g / min) - Cerebral blood flow will be measured using arterial spin labelling
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR) - standardized uptake value ratio of amyloid tracer using positron emission tomography
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
3 years

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Professor Katherine Samaras - Sydney
Recruitment hospital [2] 0 0
Garvan Institute to Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04511416
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katherine Samaras, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
61292958312
Fax 0 0
Email 0 0
k.samaras@garvan.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04511416