fMRI Study of Effects of Nasal Insulin on Memory

Study Overview
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Brief Summary
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Recent research has suggested insulin may be involved in how human's form and recall memories. This study is designed to look at how nasal insulin is used in the brain. Specifically, how insulin alters the various connections within brain regions that occur while adults perform simple attention and memory tasks. This study is divided into two parts: blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The blood draw procedure is designed to look at the effects of intranasal insulin using a Precision Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those asked to participate will receiving a low-dose saline solution and low-dose of insulin through a nasal spray followed by a blood draw session to measure your blood glucose and insulin levels over a 90 minute period. Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI). During the scan, participants will complete a series of memory tasks reflected on a computer screen. The trial will be randomized and double-blinded.

Official Title
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Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing

Conditions
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Human Memory, Intranasal Insulin

Intervention / Treatment
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* Drug: Intranasal Insulin
* Drug: Intranasal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adults over the age of 18 Exclusion Criteria: any existing health conditions: including diabetes, history of alcoholism or drug dependence contraindications to Magnetic Resonance Imaging (MRI): any non-titanium metal in the head or body

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Insulin<br>Healthy participants will self-administer 20 IU of Humulin® R U-100 with the Precision Olfactory Delivery (POD) delivery device and complete a memory task in an fMRI (functional Magnetic Resonance Imaging) scanner. | Drug: Intranasal Insulin<br>* All participants in the devise testing portion of the study will self-administer a 20 IU dose of intranasal insulin. Half of the participants in the function Magnetic Resonance Imaging portion of the study will also self-administer a 20 IU dose of intranasal insulin.<br>* Other names: Humulin® R U-100;|
| Placebo Comparator: Saline Placebo<br>Healthy participants will self-administer a saline solution with the Precision Olfactory Delivery (POD) delivery device and complete a memory task in an fMRI (functional Magnetic Resonance Imaging) scanner. | Drug: Intranasal Saline<br>* All participants in the devise testing portion of the study will self-administer a 20 mL dose of intranasal saline. Half of the participants in the function Magnetic Resonance Imaging portion of the study will also self-administer a 20 mL dose of intranasal saline.<br>* Other names: Sterile Water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Memory Recall Performance during functional Magnetic Resonance Imaging task | Recall performance will be measured based off a forced recall memory task. Participants will be asked to categorizes images as indoor or outdoor during an encoding task and then show a series of images and asked to indicated if the pictures is 'old' or 'new' in a recall task. The score will be calculated as a percentage of images correctly identified as 'old.' | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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memory, insulin