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Clinical Trials/NCT02758691
NCT02758691
Completed
Phase 1

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

Virginia Polytechnic Institute and State University0 sites45 target enrollmentDecember 2015

Overview

Phase
Phase 1
Intervention
Intranasal Insulin
Conditions
Human Memory
Sponsor
Virginia Polytechnic Institute and State University
Enrollment
45
Primary Endpoint
Change in Memory Recall Performance during functional Magnetic Resonance Imaging task
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
May 10, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rosalyn Moran

Assistant Professor

Virginia Polytechnic Institute and State University

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: 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.

Intervention: Intranasal Saline

Outcomes

Primary Outcomes

Change in Memory Recall Performance during functional Magnetic Resonance Imaging task

Time Frame: 1 day

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.'

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