Preventing Cognitive Decline With Metformin

Cognitive Decline Clinical Trial

— MetMemory  

Official title:

Preventing Cognitive Decline With Metformin:: The MetMemory Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511416
• Other study ID #: 1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2022
• Est. completion date: December 2027

Study information

• Verified date: June 2022
• Source: Garvan Institute of Medical Research
• Contact: Katherine Samaras, MD, PhD
• Phone: 61292958312
• Email: k.samaras[@]garvan.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Drug:
• Metformin XR, 500-2000mg nocte
anti diabetic medication

Locations

Country	Name	City	State
Australia	Garvan Institute to Medical Research	Sydney
Australia	Professor Katherine Samaras	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Garvan Institute of Medical Research	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Primary	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.	3 years
Secondary	changes in processing speed domain Z-score	processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B	3 years
Secondary	changes in language performance domain Z-score	language performance domain measured by the Category Fluency (Animals) neuropsychological test	3 years
Secondary	changes in attention performance domain Z-score	attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test	3 years
Secondary	changes in Cogstate brief battery performance Z-score	computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)	3 years
Secondary	changes in total brain volume (cubic millimetres)	total grey and white matter volume	3 years
Secondary	changes in hippocampal volume (cubic millimetres)	volume of the right and left hippocampal regions of the brain	3 years
Secondary	changes in parahippocampal volume (cubic millimetres)	volume of the right and left parahippocampal regions of the brain	3 years
Secondary	changes in brain white matter hyperintensity number	the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging	3 years
Secondary	changes in cerebral blood flow (mL / 100 g / min)	Cerebral blood flow will be measured using arterial spin labelling	3 years
Secondary	changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)	standardized uptake value ratio of amyloid tracer using positron emission tomography	3 years
Secondary	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.	3 years
Secondary	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	3 years
Secondary	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)	3 years