We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638519
Recruitment Status : Recruiting
First Posted : December 23, 2015
Last Update Posted : October 26, 2022
Sponsor:
Collaborators:
Lakehead University
Thunder Bay Regional Health Sciences Centre
Information provided by (Responsible Party):
Thunder Bay Regional Research Institute

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date October 26, 2022
Study Start Date  ICMJE June 27, 2016
Estimated Primary Completion Date January 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)		 Signal-to-Noise Ratio (SNR) [ Time Frame: Three years ]
All scans will be optimized for the highest SNR possible; No aggregation of data
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)		 P-Value [ Time Frame: Three years ]
To be calculated from a students paired t-test for signal change between healthy participant scans and participants with Alzheimer disease
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimer's Disease
Official Title  ICMJE Hyperpolarized Xenon-129 Functional Magnetic Resonance Imaging of Healthy Volunteers and Participants With Alzheimer's Disease
Brief 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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Other: Traditional Proton fMRI
    Conventional proton fMRI will be performed. During the functional imaging acquisitions, the participant will be asked by the research team to perform simple tasks. These tasks will be completed while the participant breathes air (normal breathing).
  • Other: Hyperpolarized Xenon-129 fMRI
    HP 129Xe fMRI data will be acquired from all participants. Hyperpolarized xenon (NeuroXene) is expected to produce images that provide more clinically relevant information than traditional proton scans. Simple tasks will be performed by participants while breathing NeuroXene according to several inhalation procedures.
    Other Name: HP 129Xe fMRI
  • Drug: Hyperpolarized Xenon-129
    Participants will be asked to inhale specified amounts of NeuroXene according to several inhalation procedures. NeuroXene is the trade name for hyperpolarization of xenon-129 balanced with oxygen and nitrogen using a Xemed LLC polarizer. Hyperpolarization does not change the chemical or physical properties of xenon gas.
    Other Name: NeuroXene
  • Device: 1H-129Xe Dual-Tuned Quadrature Head Coil
    A 1H-129Xe dual-tuned quadrature head coil (Clinical MR Solutions, LLC) will be used in this study. The RF coil will be used to acquire MRI images of the human brain after inhalation of hyperpolarized xenon-129 gas, and permits the acquisition of both conventional proton and HP xenon gas images.
Study Arms  ICMJE
  • Healthy Volunteers
    Healthy volunteers will inhale NeuroXene using various breathing methods. The CMRS 1H-129Xe dual-tuned quadrature head coil will be used to acquire MRI images of the human brain after inhalation of NeuroXene. The coil permits the acquisition of both conventional proton and HP xenon gas images. Two types of MRI scans will be performed: Traditional proton fMRI and Hyperpolarized Xenon-129 fMRI. The order of scans will be randomized to account for bias caused by scan order.
    Interventions:
    • Other: Traditional Proton fMRI
    • Other: Hyperpolarized Xenon-129 fMRI
    • Drug: Hyperpolarized Xenon-129
    • Device: 1H-129Xe Dual-Tuned Quadrature Head Coil
  • Alzheimer's Disease Participants
    Alzheimer's disease participants will inhale NeuroXene using various breathing methods. The CMRS 1H-129Xe dual-tuned quadrature head coil will be used to acquire MRI images of the human brain after inhalation of NeuroXene. The coil permits the acquisition of both conventional proton and HP xenon gas images. Two types of MRI scans will be performed: Traditional proton fMRI and Hyperpolarized Xenon-129 fMRI. The order of scans will be randomized to account for bias caused by scan order.
    Interventions:
    • Other: Traditional Proton fMRI
    • Other: Hyperpolarized Xenon-129 fMRI
    • Drug: Hyperpolarized Xenon-129
    • Device: 1H-129Xe Dual-Tuned Quadrature Head Coil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 28, 2023
Estimated Primary Completion Date January 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A participant is eligible for inclusion in the study if the individual meets all of the following criteria:

  1. Self-reported proficiency in English language.
  2. Equal to or more than 8 years of education.
  3. Normal or corrected to normal vision.
  4. Able to provide informed consent.
  5. Able to hold their breath for 20 seconds.

Normal cognition for healthy participant group inclusion criteria:

  1. Preserved independence in functional abilities.
  2. MoCA score no less than 26.
  3. Males and non-lactating females of 18 to 85 years of age.

Alzheimer's disease group inclusion criteria:

  1. Participants meet National Institute on Aging-Alzheimer's Association for probable or possible Alzheimer's Disease dementia.
  2. MoCA score no less than 16.
  3. Males and non-lactating females of 60 to 85 years of age.
  4. Have a family member, close friend, or LAR that can be present for the informed consent process and study visits.

Exclusion Criteria:

A participant is ineligible for the study if the individual meets any of the following criteria:

  1. Serious underlying medical condition, other, then the condition being investigated, which may affect cognitive function of the participant (in the opinion of the investigator): substance abuse, psychotic or depressive disorder, advanced or poorly controlled cardiac, pulmonary, hepatic, renal, neurological disorders in which the patient has significant speech, visual, motor or cognitive deficit, seizure disorders, endocrine or infectious disease or active malignancy.
  2. MRI incompatibility as determined by MR Technologist during MRI screening.
  3. Self-identifies as claustrophobic.
  4. Female exclusion only: Are or may be pregnant; Planning on becoming pregnant.
  5. Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor.
  6. Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor.
  7. Is currently an employee of the PI at the Thunder Bay Regional Research Institute (TBRRI) and/or Lakehead University.

Normal cognition group exclusion criteria:

1. History of diagnosed neurological disease or injury.

Alzheimer's disease group exclusion criteria:

  1. Existing diagnosis of dementia of etiology other than Alzheimer's disease.
  2. Acute Delirium on the day of scanning (CAM tool assessment)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mitchell Albert, Ph.D. 807-684-7270 albertmi@tbh.net
Contact: Jennifer Plata, HBSc 807-684-7270 plataj@tbh.net
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638519
Other Study ID Numbers  ICMJE RP-307-08312015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Thunder Bay Regional Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Thunder Bay Regional Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Lakehead University
  • Thunder Bay Regional Health Sciences Centre
Investigators  ICMJE Not Provided
PRS Account Thunder Bay Regional Research Institute
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP