NCT02758691|CompletedPhase 1
fMRI Study of Effects of Nasal Insulin on Memory
Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing
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Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing
Sponsor study identifier
interventional
45
0 countries
N/A
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
May 10, 2017
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2016
Actual (reported)May 2, 2016
Actual (reported)June 2016
Actual (reported)May 10, 2017
Actual (reported)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
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.
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.
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.
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.
45 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2016
First Posted
May 2, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
May 10, 2017
Actual (reported)Last Updated
October 26, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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