Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04511416
Registration number
NCT04511416
Ethics application status
Date submitted
2/07/2020
Date registered
13/08/2020
Titles & IDs
Public title
Preventing Cognitive Decline With Metformin
Query!
Scientific title
Preventing Cognitive Decline With Metformin:: The MetMemory Study
Query!
Secondary ID [1]
0
0
1
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MetMemory
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Other mental health disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
changes in memory Z-score
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
3 years
Query!
Primary outcome [2]
0
0
changes in executive function Z-score
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [1]
0
0
changes in processing speed domain Z-score
Query!
Assessment method [1]
0
0
processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B
Query!
Timepoint [1]
0
0
3 years
Query!
Secondary outcome [2]
0
0
changes in language performance domain Z-score
Query!
Assessment method [2]
0
0
language performance domain measured by the Category Fluency (Animals) neuropsychological test
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [3]
0
0
changes in attention performance domain Z-score
Query!
Assessment method [3]
0
0
attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test
Query!
Timepoint [3]
0
0
3 years
Query!
Secondary outcome [4]
0
0
changes in Cogstate brief battery performance Z-score
Query!
Assessment method [4]
0
0
computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)
Query!
Timepoint [4]
0
0
3 years
Query!
Secondary outcome [5]
0
0
changes in total brain volume (cubic millimetres)
Query!
Assessment method [5]
0
0
total grey and white matter volume
Query!
Timepoint [5]
0
0
3 years
Query!
Secondary outcome [6]
0
0
changes in hippocampal volume (cubic millimetres)
Query!
Assessment method [6]
0
0
volume of the right and left hippocampal regions of the brain
Query!
Timepoint [6]
0
0
3 years
Query!
Secondary outcome [7]
0
0
changes in parahippocampal volume (cubic millimetres)
Query!
Assessment method [7]
0
0
volume of the right and left parahippocampal regions of the brain
Query!
Timepoint [7]
0
0
3 years
Query!
Secondary outcome [8]
0
0
changes in brain white matter hyperintensity number
Query!
Assessment method [8]
0
0
the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging
Query!
Timepoint [8]
0
0
3 years
Query!
Secondary outcome [9]
0
0
changes in cerebral blood flow (mL / 100 g / min)
Query!
Assessment method [9]
0
0
Cerebral blood flow will be measured using arterial spin labelling
Query!
Timepoint [9]
0
0
3 years
Query!
Secondary outcome [10]
0
0
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
Query!
Assessment method [10]
0
0
standardized uptake value ratio of amyloid tracer using positron emission tomography
Query!
Timepoint [10]
0
0
3 years
Query!
Secondary outcome [11]
0
0
changes in cognitive performance Z-score using the NIH tool box
Query!
Assessment method [11]
0
0
The NIH Toolbox currently contains the following cognitive tests: Flanker, Pattern Comparison, Picture Sequence Memory and Dimensional Change Card Sort.
Query!
Timepoint [11]
0
0
3 years
Query!
Secondary outcome [12]
0
0
change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging
Query!
Assessment method [12]
0
0
change blood oxygen-level-dependent time-series signals, measured by functional MRI
Query!
Timepoint [12]
0
0
3 years
Query!
Secondary outcome [13]
0
0
changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
Query!
Assessment method [13]
0
0
fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
Query!
Timepoint [13]
0
0
3 years
Query!
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.
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/02/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2027
Query!
Actual
Query!
Sample size
Target
242
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Professor Katherine Samaras - Sydney
Query!
Recruitment hospital [2]
0
0
Garvan Institute to Medical Research - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
- Sydney
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Garvan Institute of Medical Research
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
National Health and Medical Research Council, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04511416
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Katherine Samaras, MD, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
61292958312
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04511416