fMRI Study of Effects of Nasal Insulin on Memory

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-05-10

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.

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Detailed Description

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Conditions

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Human Memory Intranasal Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intranasal Insulin

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.

Group Type EXPERIMENTAL

Intranasal Insulin

Intervention Type DRUG

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.

Saline Placebo

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.

Group Type PLACEBO_COMPARATOR

Intranasal Saline

Intervention Type DRUG

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.

Interventions

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Intranasal Insulin

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.

Intervention Type DRUG

Intranasal Saline

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.

Intervention Type DRUG

Other Intervention Names

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Humulin® R U-100 Sterile Water

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes