Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose

NCT ID: NCT05866367

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2024-06-28

Brief 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 mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.

12 healthy adults will be randomly assigned to receive a single dose of either 40 units ("low dose" group) or 80 units ("high dose" group) of insulin. Participants will undergo image-guided lumbar puncture (spinal tap) performed by a study radiologist. 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 the SipNose device to effectively deliver insulin to the central nervous system of humans as measured in the cerebrospinal fluid.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Low dose Intranasal Insulin

One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.

Group Type: EXPERIMENTAL

Low dose Regular Insulin

Intervention Type: DRUG

Regular insulin administered intranasally at either 40 IU

High dose Intranasal Insulin

One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.

Group Type: EXPERIMENTAL

High dose Regular insulin

Intervention Type: DRUG

Regular insulin administered intranasally at either 80 IU

Interventions

Low dose Regular Insulin

Regular insulin administered intranasally at either 40 IU

Intervention Type: DRUG

High dose Regular insulin

Regular insulin administered intranasally at either 80 IU

Intervention Type: DRUG

Other Intervention Names

Novolin-R; Novolin-R

Eligibility Criteria

Inclusion Criteria

1. Subject is between ≥18 and ≤ 35 years of age

2. Subject's body mass index is between >=18.5 and <=24.9

3. Subject must be proficient in speaking English to comply with instructions and measures for the study

4. Subject can provide written informed consent

5. Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leah R Hanson, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neuroscience Research

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A21-299

Identifier Type: -

Identifier Source: org_study_id