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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
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
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
changes in executive function Z-score
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
changes in processing speed domain Z-score
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
changes in language performance domain Z-score
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
changes in attention performance domain Z-score
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
changes in Cogstate brief battery performance Z-score
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
changes in total brain volume (cubic millimetres)
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
changes in hippocampal volume (cubic millimetres)
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
changes in parahippocampal volume (cubic millimetres)
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
changes in brain white matter hyperintensity number
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
changes in cerebral blood flow (mL / 100 g / min)
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
changes in cognitive performance Z-score using the NIH tool box
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
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)
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
Sex
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
242
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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