Clinical trial NCT05866367: Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
Official title: Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Insulin Concentration Over Time - Cerebrospinal Fluid
timeFrame: 0-40 minutes post-intranasal administration
measure: Cmax of insulin concentration - Cerebrospinal Fluid
timeFrame: 0-40 minutes post-intranasal administration
measure: Tmax of insulin concentration - Cerebrospinal Fluid
timeFrame: 0-40 minutes post-intranasal administration
measure: AUC (area under the curve) of insulin concentration - Cerebrospinal Fluid
timeFrame: 0-40 minutes post-intranasal administration
Secondary outcomes:
measure: Insulin Concentration Over Time - Serum
timeFrame: 0-40 minutes post-intranasal administration
measure: Cmax of insulin concentration - Serum
timeFrame: 0-40 minutes post-intranasal administration
measure: Tmax of insulin concentration - Serum
timeFrame: 0-40 minutes post-intranasal administration
measure: AUC (area under the curve) of insulin concentration - Serum
timeFrame: 0-40 minutes post-intranasal administration
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neuroscience Research
name: Leah R Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References: