Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434038
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Measurement of Insulin Levels in the Cerebrospinal Fluid of Healthy Adults After a Single Intranasal Dose - Middle Age
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Measurement of Insulin Levels in the Cerebrospinal Fluid CSF of Healthy Adults After a Single Intranasal Dose - Middle Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INI-CSF-MA
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-SC220220 | OTHER | Department of Defense | None |