fMRI Study of Effects of Nasal Insulin on Memory

Intranasal Insulin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758691
• Other study ID #: VT15-462
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: May 10, 2017

Study information

• Verified date: October 2018
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 10, 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Memory
• Intranasal Insulin

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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