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Can a nasal spray and diabetes pill boost brain power?

NCT ID NCT05081219

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a nasal insulin spray and a diabetes pill called empagliflozin, alone or together, could improve memory and brain function in 47 adults aged 55-85 with mild cognitive impairment or early Alzheimer's disease. The goal was to see if these treatments are safe and help correct energy problems in the brain. Participants were already showing signs of Alzheimer's-related brain changes.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Sep 2021

Finished

Sep 2024

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

55 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age 55 to 85 (inclusive) 2. Fluent in English 3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD) 4. Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria 5. Stable medical condition for 3 months prior to screening visit 6. Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician) 7. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician Exclusion Criteria: 1. A diagnosis of dementia other than Alzheimer's disease (AD) 2. History of a clinically significant stroke 3. Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder 4. Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus 5. Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit 6. History of seizure within past five years 7. Pregnancy or possible pregnancy 8. Use of anticoagulants, unless documentation received from prescribing clinician that anticoagulant medication can be held before lumbar puncture, and approved by study clinician 9. Residence in a skilled nursing facility at screening 10. Use of an investigational agent within two months of screening visit 11. 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 the study physician)

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

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

Alzheimer disease Cognitive impairment Mild cognitive impairment

Contacts and locations

Locations

  • Wake Forest University Health Sciences / Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.