Measurement of Insulin Levels in the Cerebrospinal Fluid of Healthy Adults After a Single Intranasal Dose - Middle Age

Launched by HEALTHPARTNERS INSTITUTE · May 23, 2024

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ClinConnect Summary

This clinical trial is investigating whether insulin, a medication commonly used to treat diabetes, can reach the brain and spinal cord when given as a nasal spray. Researchers believe that this method could help improve memory and mood in people with certain brain conditions, but they need more evidence to confirm how well it works. The study will involve 18 healthy middle-aged adults who will receive either a low or high dose of intranasal insulin, or a placebo (a harmless solution that doesn’t contain the drug). Participants will have a spinal tap, which is a procedure where a small amount of fluid surrounding the brain and spinal cord is collected, to measure insulin levels in both the spinal fluid and blood at different times after taking the nasal spray.

To be eligible for the trial, participants need to be between 36 and 55 years old, have a healthy weight, and score well on a simple memory test. It's important that they can speak English and provide written consent. However, individuals with certain health issues, such as severe allergies to insulin or significant medical conditions affecting the brain or heart, won't be able to participate. Overall, participants can expect to play a key role in helping researchers learn more about how intranasal insulin could potentially benefit brain health.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is between ≥36 and ≤ 55 years of age
• • 2. Subject's BMI is between \>=18.5 and \<=24.9, or can safely undergo a lumbar puncture at the discretion of the radiologist
• • 3. MOCA score ≥26
• • 4. Subject must be proficient in speaking English to comply with instructions and measures for the study
• • 5. Subject can provide written informed consent
• • 6. Female subjects must have either: (1) a negative pregnancy test at the screening visit and treatment visit 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
• • 8. Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator