fMRI Study of Effects of Nasal Insulin on Memory

Virginia Polytechnic Institute and State University

Status and phase: Completed; Phase 1

Conditions: Intranasal Insulin; Human Memory

Treatments: Drug: Intranasal Saline; Drug: Intranasal Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02758691

VT15-462

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

Intranasal Insulin

Experimental group

Description:

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.

Treatment:

Drug: Intranasal Insulin

Saline Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Intranasal Saline