Measurement of Insulin Levels in the Cerebrospinal Fluid of Healthy Adults After a Single Intranasal Dose - Middle Age

Summary

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with neurological diseases such as mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.

18 healthy middle-aged adults will be randomly assigned to receive a single intranasal dose of 40 units insulin ("low dose" group), 80 units insulin ("high dose" group), or saline (placebo, or control group). Participants will undergo an image-guided lumbar puncture (spinal tap) performed by a study clinician. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of insulin to reach the brain after intranasal administration.

Conditions

• Healthy

Interventions

OTHER

0.9% Saline

Placebo control

DRUG

Low Dose Regular insulin

Administered intranasally at 40 IU

DRUG

High Dose Regular insulin

Administered Intranasally at 80 IU

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences

  collaborator FED

• Department of Defense Congressionally Directed Medical Research Program

  collaborator UNKNOWN

• HealthPartners Institute

  lead OTHER

Principal Investigators

• Leah R Hanson, PhD · HealthPartners Institute

• Kimberly Byrnes, PhD · Uniformed Services University of the Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

36 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-30

Primary Completion

2026-02-28

Completion

2026-02-28

FDA Drug

Yes

Countries

• United States

Study Locations