Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05866367 · ClinicalTrials.gov registry record · Phase 1
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
A Phase 1 study, sponsored by HealthPartners Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT05866367 is a Phase 1 study that was terminated before completion, run by HealthPartners Institute. The registered enrollment target is 2 participants.
The verdict
NCT05866367, a Phase 1 study, was terminated before completion, sponsored by HealthPartners Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Low dose Regular Insulin
- DRUG High dose Regular insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05866367
The ClinicalTrials.gov registry entry for NCT05866367 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HealthPartners Institute, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low dose Regular Insulin is the first listed.
NCT05866367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05866367 about?
NCT05866367 is a clinical study titled "Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose". 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 ...
What is the current status of trial NCT05866367?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2023-08-16. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT05866367?
The interventions under investigation include: Low dose Regular Insulin (DRUG), High dose Regular insulin (DRUG).
Who is sponsoring clinical trial NCT05866367?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.