Preventing Cognitive Decline with Metformin

NCT04511416 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline

Keywords

cognitive decline; dementia; cerebrovascular disease; insulin resistance; neurodegeneration; inflammation; diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• changes in processing speed domain Z-score

  3 years

• changes in language performance domain Z-score

  3 years

• changes in attention performance domain Z-score

  3 years

• changes in Cogstate brief battery performance Z-score

  3 years

• changes in total brain volume (cubic millimetres)

  3 years

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Metformin

Drug: Metformin XR, 500-2000mg nocte

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Metformin XR, 500-2000mg nocte

Interventions

Metformin XR, 500-2000mg nocte DRUG

Metformin XR, 500-2000mg nocte

Also known as: Placebo

Intervention; Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Life-threatening illnesses to preclude participation in a 3-year study;
• Contraindications to the use of metformin (severe heart failure or eGFR \<40).

Sponsors & Collaborators

• Garvan Institute of Medical Research: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Garvan Institute of Medical Research

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Cerebrovascular Disorders; Insulin Resistance; Nerve Degeneration; Inflammation; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised placebo controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: August 13, 2020
• Study Start: July 15, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)