Clinical trial NCT04511416: Preventing Cognitive Decline with Metformin
Official title: Preventing Cognitive Decline with Metformin:: the MetMemory Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cognitive Decline
Keywords: cognitive decline
dementia
cerebrovascular disease
insulin resistance
neurodegeneration
inflammation
diabetes
Lead sponsor: Garvan Institute of Medical Research
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2020-08-13
Enrollment: 242
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised placebo controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: changes in memory Z-score
timeFrame: 3 years
measure: changes in executive function Z-score
timeFrame: 3 years
Secondary outcomes:
measure: changes in processing speed domain Z-score
timeFrame: 3 years
measure: changes in language performance domain Z-score
timeFrame: 3 years
measure: changes in attention performance domain Z-score
timeFrame: 3 years
measure: changes in Cogstate brief battery performance Z-score
timeFrame: 3 years
measure: changes in total brain volume (cubic millimetres)
timeFrame: 3 years
measure: changes in hippocampal volume (cubic millimetres)
timeFrame: 3 years
measure: changes in parahippocampal volume (cubic millimetres)
timeFrame: 3 years
measure: changes in brain white matter hyperintensity number
timeFrame: 3 years
measure: changes in cerebral blood flow (mL / 100 g / min)
timeFrame: 3 years
measure: changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)
timeFrame: 3 years
measure: changes in cognitive performance Z-score using the NIH tool box
timeFrame: 3 years
measure: change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging
timeFrame: 3 years
measure: changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)
timeFrame: 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Garvan Institute of Medical Research
state: New South Wales
Study officials:
References: