Diabetes drug may double as brain protector in new trial

NCT ID NCT07694596

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study investigates whether SGLT2 inhibitors, a class of diabetes medications, can slow cognitive decline in people aged 50 and older with type 2 diabetes. Participants are randomly assigned to receive either standard diabetes care plus an SGLT2 inhibitor (empagliflozin or dapagliflozin) or standard care alone. Over 12 months, researchers measure changes in executive function, memory, and other cognitive abilities, along with brain imaging and blood markers. The goal is to see if these drugs offer brain benefits beyond blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SGLT2 inhibitor (empagliflozin or dapagliflozin)
What this could lead to
If successful, this could show that a common diabetes drug also helps protect the brain from cognitive decline in people with type 2 diabetes.
What could go wrong
This is a relatively small, early-stage trial with 200 participants, so results may not apply to everyone. The cognitive benefits are uncertain, and side effects from the drugs are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * adults aged 50 years or older. * diagnosis of type 2 diabetes mellitus according to current American Diabetes - - association (ADA) diagnostic criteria. * duration of type 2 diabetes mellitus of at least 5 years. * glycated haemoglobin (HbA1c) ≤8.5% (≤69 mmol/mol) at screening. * estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m². * stable glucose-lowering therapy for at least 3 months before enrolment. * able to complete neuropsychological assessments and all study procedures. * willing and able to wear a continuous glucose monitoring (CGM) sensor and a physical activity monitor. * able to provide written informed consent. Exclusion Criteria: * previous or current treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor. * Montreal Cognitive Assessment (MoCA) score \<20 at screening. * diagnosis of dementia or another major neurocognitive disorder. * history of stroke or transient ischaemic attack within the previous 6 months. * Parkinson's disease, multiple sclerosis, epilepsy, or another major neurological disorder affecting cognitive function. * severe psychiatric illness likely to interfere with study participation or cognitive assessment. * estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². * history of diabetic ketoacidosis. * recurrent urinary tract infections (≥3 episodes during the previous year). * contraindication to magnetic resonance imaging (MRI). * pregnancy, breastfeeding, or planned pregnancy during the study period. * active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer). * moderate or severe hepatic impairment (Child-Pugh Class B or C). * alcohol or substance abuse likely to interfere with study participation. * presence of an established indication for mandatory SGLT2 inhibitor therapy according to current international clinical practice guidelines (e.g., symptomatic heart failure or chronic kidney disease). * participation in another interventional clinical trial within the previous 30 days. * any medical condition that, in the opinion of the investigator, could compromise participant safety, adherence to the protocol, or interpretation of study results.

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Conditions

The condition(s) this trial relates to.

cognitive disorder Cognitive Dysfunction Nerve Degeneration type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Health Center

    Koper, 6000, Slovenia

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