跳至主要内容
临床试验/NCT02758691
NCT02758691已完成1 期

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

Virginia Polytechnic Institute and State University0 个研究点目标入组 45 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
45
主要终点
Change in Memory Recall Performance during functional Magnetic Resonance Imaging task

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adults over the age of 18

排除标准

  • 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

研究组 & 干预措施

Intranasal Insulin

Experimental

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.

干预措施: Intranasal Insulin (Drug)

Saline Placebo

Placebo Comparator

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.

干预措施: Intranasal Saline (Drug)

结局指标

主要结局

Change in Memory Recall Performance during functional Magnetic Resonance Imaging task

时间窗: 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.'

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosalyn Moran

Assistant Professor

Virginia Polytechnic Institute and State University

相似试验