Preventing Cognitive Decline with Metformin

NCT ID: NCT04511416

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised placebo controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Metformin

Group Type ACTIVE_COMPARATOR

Metformin XR, 500-2000mg nocte

Intervention Type DRUG

Metformin XR, 500-2000mg nocte

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Metformin XR, 500-2000mg nocte

Intervention Type DRUG

Metformin XR, 500-2000mg nocte

Interventions

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Metformin XR, 500-2000mg nocte

Metformin XR, 500-2000mg nocte

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Garvan Institute of Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Garvan Institute of Medical Research

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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