Intranasal Insulin for Healthy Adults
(INI-CSF-MA Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug intranasal insulin for healthy adults?
Research shows that intranasal insulin, like Nasulin, can be absorbed effectively through the nasal passage, which suggests it could be a viable way to deliver insulin quickly. Additionally, insulin detemir, a component of the treatment, has been shown to effectively manage blood sugar levels in people with diabetes, indicating its potential effectiveness in other uses.12345
Is intranasal insulin safe for healthy adults?
How is intranasal insulin different from other insulin treatments?
Intranasal insulin is unique because it is administered through the nose, allowing for rapid absorption directly into the bloodstream, which can be faster than traditional injections. This method also shows potential benefits for cognitive improvement in conditions like mild cognitive impairment or early-stage Alzheimer's disease.126910
What is the purpose of this trial?
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.
Research Team
Leah R Hanson, PhD
Principal Investigator
HealthPartners Institute
Kimberly Byrnes, PhD
Principal Investigator
Uniformed Services University of the Health Sciences
Eligibility Criteria
This trial is for healthy middle-aged adults. Participants must be willing to receive a nasal spray and undergo a lumbar puncture (spinal tap) to collect cerebrospinal fluid samples.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intranasal dose of insulin or saline, followed by lumbar puncture and sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Intranasal Insulin
Intranasal Insulin is already approved in United States, European Union for the following indications:
- Diabetes
- Diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
Uniformed Services University of the Health Sciences
Collaborator
United States Department of Defense
Collaborator