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Clinical Trial Summary

This study involves imaging participants' brains using MRI. The goal is to develop a high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain magnetic resonance imaging, which can provide more sensitive measurement of brain function, facilitating the development of drugs for more successful treatment of Alzheimer's disease.


Clinical Trial Description

The described study is a pilot study in which the investigators aim to develop an enhanced sensitivity tool for assessment of neural function. Participation involves at least two study visits no longer than three hours in length each. During visit 1, informed consent and screening for eligibility will take place. During visit 2, fMRI scanning will take place in which participants will complete simple tasks. Two types of MRI scans will be performed: traditional proton fMRI and hyperpolarized xenon-129 fMRI (HP 129Xe fMRI) scans. The trade name for xenon-129 hyperpolarized with a Xemed LLC polarizer is NeuroXene. Participants will be placed in the 3T MRI at the Thunder Bay Regional Research Institute with a Clinical MR Solutions (CMRS) Dual Brain Coil that fits over their head like a helmet. Several inhalation procedures will be performed by participants when breathing NeuroXene from a tube in the scanner. Preparation and administration of NeuroXene and the CMRS Dual Brain Coil will be carried out according to the SOP's developed by the TBRRI and Xemed LLC. MRI scanning will be performed with a MR Tech and Registered Respiratory Therapist present. Dispensing of 129Xe will be monitored using a gas dispensing form and a drug accountability log. This study will have a monitor assigned to it from the TBRRI that is not involved in this clinical trial. This is to ensure participant safety and adherence to the protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02638519
Study type Interventional
Source Thunder Bay Regional Health Research Institute
Contact Mitchell Albert, Ph.D.
Phone 807-684-7270
Email albertmi@tbh.net
Status Recruiting
Phase Early Phase 1
Start date June 27, 2016
Completion date January 28, 2026

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