Can insulin or a diabetes drug boost Alzheimer's treatment?
NCT ID NCT07756294
First seen Aug 10, 2026 · Last updated Aug 26, 2026 · Updated 3 times
Summary
This trial asks whether adding intranasal insulin or empagliflozin to standard anti-amyloid therapy can improve outcomes for people with mild cognitive impairment or early Alzheimer's disease. Participants will receive one of the two study drugs or a placebo, alongside their prescribed anti-amyloid treatment. The study will track safety and cognitive changes to see if these add-ons offer extra benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intranasal insulin and empagliflozin (an oral diabetes drug), each tested against placebo
- What this could lead to
- If successful, this could point toward a way to enhance the benefits of anti-amyloid treatments for early Alzheimer's disease.
- What could go wrong
- This is a small, early-phase trial, so results may not hold up in larger studies. The medications also carry potential side effects, and the added benefit over standard anti-amyloid therapy is unproven.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- 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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55 to 85 years
- 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: * Fluent in English * Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment * Amyloid positive by PET or cerebrospinal fluid criteria * Stable medical condition for 3 months prior to screening visit * Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician) * Stable on Anti-Amyloid Targeting Therapy (lecanemab or donanemab) for at least 8 weeks prior to Baseline Visit * If receiving an acetylcholinesterase inhibitor (donepezil, rivastigmine, galantamine) or memantine or both, must be stable on a dose for at least 30 days prior to Baseline Visit * Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study clinician * Participants must have a study partner who agrees to participate throughout the duration of the study. The study partner must have frequent and sufficient contact (approximately 10 hours per week) with the participant and be able to provide accurate information regarding the participant's cognitive and functional abilities. Exclusion Criteria: * A diagnosis of dementia other than Alzheimer's disease * History of a clinically significant stroke, history of transient ischemic attack within 12 months, or any history of seizures * Current evidence or history in past two years of head injury with loss of consciousness, any major psychiatric disorder including psychosis, unstable major depressive disorder, bipolar disorder * Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus * Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit * Cancer within the past 2 years with the exception of non-melanoma skin cancers and non-metastatic prostate cancer that has been stable for at least 6 months * Pregnancy or possible pregnancy * Use of anticoagulants * Residence in a skilled nursing facility at screening * Use of an investigational agent within two months of screening visit * Regular use of alcohol, narcotics, anticonvulsants, anti-Parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case-by-case basis by study clinician) * Any history of immunologic disease (e.g. lupus, rheumatoid arthritis, Crohn's disease) or systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives * History of a bleeding disorder that is not under adequate control, including a platelet count less than 50,000 or INR greater than 1.5 * Contraindications for MRI, including claustrophobia or the presence of contraindicated metal implants/cardiac pacemaker * Baseline MRI Findings: More than four microhemorrhages defined as 10mm or less at the greatest diameter; A single macro hemorrhage greater than 10mm at greatest diameter; An area of superficial siderosis; Evidence of vasogenic edema; More than two lacunar infarcts or stroke involving a major vascular territory; Severe subcortical hyperintensities consistent with Fazekas score of 3; Evidence of amyloid beta-related angiitis (ABRA); Cerebral amyloid angiopathy (CAA); Cerebral contusion, encephalomalacia, brain aneurysm or other vascular malformations, central nervous system infection, brain tumor, or other major intracranial pathology that may cause cognitive impairment
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging
Winston-Salem, North Carolina, 27157, United States
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