Diabetes drug may double as brain protector in new trial
NCT ID NCT07694596
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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