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Nasal insulin brain study pulled before it even started

NCT ID NCT06434038

Knowledge-focused Sponsor: HealthPartners Institute 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if insulin, given as a nasal spray, reaches the fluid around the brain and spinal cord. Researchers planned to give a single dose of low or high insulin (or a placebo) to 18 healthy adults aged 36–55, then collect samples via spinal tap at several time points. However, the study was withdrawn before enrolling anyone, so no data were collected.

What this could mean

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

Active substance
insulin (Novolin-R) nasal spray
What this could lead to
If successful, this could show that nasal insulin reaches the brain, supporting future research into memory and mood treatments.
What could go wrong
The study was withdrawn before any participants enrolled, so no results are available. It was a small, early-phase trial with healthy volunteers, not patients.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Aug 2025

An estimate. Start dates often move.

Expected to finish

Feb 2026

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

36 to 55 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. Subject is between ≥36 and ≤ 55 years of age 2. Subject's BMI is between \>=18.5 and \<=24.9, or can safely undergo a lumbar puncture at the discretion of the radiologist 3. MOCA score ≥26 4. Subject must be proficient in speaking English to comply with instructions and measures for the study 5. Subject can provide written informed consent 6. Female subjects must have either: (1) a negative pregnancy test at the screening visit and treatment visit OR (2) be at least 2 years post-menopausal / surgically sterile. Exclusion Criteria: 1. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies. 2. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator 3. Subject has participated in a clinical trial investigation within 3 months of this study. 4. Subject has an insulin allergy 5. Subject has Insulin-dependent diabetes 6. Subject is pregnant or breast feeding 7. Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion 8. Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator

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Conditions

The condition(s) this trial relates to.

Insulin Resistance

As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota, 55130, United States

More trials for these conditions

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