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

Primary Purpose

Alzheimer Disease

Status

Recruiting

Phase

Early Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Traditional Proton fMRI

Hyperpolarized Xenon-129 fMRI

Hyperpolarized Xenon-129

1H-129Xe Dual-Tuned Quadrature Head Coil

About this trial

This is an interventional basic science trial for Alzheimer Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Normal cognition for healthy participant group inclusion criteria:

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

Alzheimer's disease group inclusion criteria:

Participants meet National Institute on Aging-Alzheimer's Association for probable or possible Alzheimer's Disease dementia.
MoCA score no less than 16.
Males and non-lactating females of 60 to 85 years of age.
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:

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.
MRI incompatibility as determined by MR Technologist during MRI screening.
Self-identifies as claustrophobic.
Female exclusion only: Are or may be pregnant; Planning on becoming pregnant.
Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor.
Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor.
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:

Existing diagnosis of dementia of etiology other than Alzheimer's disease.
Acute Delirium on the day of scanning (CAM tool assessment)

Sites / Locations

Thunder Bay Regional Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Healthy Volunteers

Alzheimer's Disease Participants

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Signal-to-Noise Ratio (SNR)

All scans will be optimized for the highest SNR possible; No aggregation of data

Secondary Outcome Measures

P-Value

To be calculated from a students paired t-test for signal change between healthy participant scans and participants with Alzheimer disease

Full Information

NCT ID

NCT02638519

First Posted

December 3, 2015

Last Updated

April 27, 2023

Sponsor

Thunder Bay Regional Health Research Institute

Collaborators

Lakehead University, Thunder Bay Regional Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT02638519

Brief Title

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

Official Title

Hyperpolarized Xenon-129 Functional Magnetic Resonance Imaging of Healthy Volunteers and Participants With Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 27, 2016 (undefined)

Primary Completion Date

January 28, 2026 (Anticipated)

Study Completion Date

January 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thunder Bay Regional Health Research Institute

Collaborators

Lakehead University, Thunder Bay Regional Health Sciences Centre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteers

Arm Type

Other

Arm Description

Arm Title

Alzheimer's Disease Participants

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Traditional Proton fMRI

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Hyperpolarized Xenon-129 fMRI

Other Intervention Name(s)

HP 129Xe fMRI

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Hyperpolarized Xenon-129

Other Intervention Name(s)

NeuroXene

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

1H-129Xe Dual-Tuned Quadrature Head Coil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Signal-to-Noise Ratio (SNR)

Description

All scans will be optimized for the highest SNR possible; No aggregation of data

Time Frame

Three years

Secondary Outcome Measure Information:

Title

P-Value

Description

To be calculated from a students paired t-test for signal change between healthy participant scans and participants with Alzheimer disease

Time Frame

Three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A participant is eligible for inclusion in the study if the individual meets all of the following criteria: Self-reported proficiency in English language. Equal to or more than 8 years of education. Normal or corrected to normal vision. Able to provide informed consent. Able to hold their breath for 20 seconds. Normal cognition for healthy participant group inclusion criteria: Preserved independence in functional abilities. MoCA score no less than 26. Males and non-lactating females of 18 to 85 years of age. Alzheimer's disease group inclusion criteria: Participants meet National Institute on Aging-Alzheimer's Association for probable or possible Alzheimer's Disease dementia. MoCA score no less than 16. Males and non-lactating females of 60 to 85 years of age. 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: 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. MRI incompatibility as determined by MR Technologist during MRI screening. Self-identifies as claustrophobic. Female exclusion only: Are or may be pregnant; Planning on becoming pregnant. Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor. Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor. 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: Existing diagnosis of dementia of etiology other than Alzheimer's disease. Acute Delirium on the day of scanning (CAM tool assessment)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mitchell Albert, Ph.D.

Phone

807-684-7270

albertmi@tbh.net

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Plata, HBSc

Phone

807-684-7270

plataj@tbh.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell Albert, Ph.D.

Organizational Affiliation

Thunder Bay Regional Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thunder Bay Regional Health Sciences Centre

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mitchell S Albert, PhD

Phone

807-684-7270

albertmi@tbh.net

First Name & Middle Initial & Last Name & Degree

Francis Hane, PhD

Phone

807-684-6958

hanef@tbh.net

First Name & Middle Initial & Last Name & Degree

Mitchell S Albert, PhD

First Name & Middle Initial & Last Name & Degree

Jane Lawrence-Dewar, PhD

First Name & Middle Initial & Last Name & Degree

Francis Hane, PhD

First Name & Middle Initial & Last Name & Degree

Ayman Hassan, MD

First Name & Middle Initial & Last Name & Degree

Alla Reznik, PhD

First Name & Middle Initial & Last Name & Degree

Karl Granberg, MD

First Name & Middle Initial & Last Name & Degree

Anton Kolobov, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

21813210

Citation

Agosta F, Pievani M, Geroldi C, Copetti M, Frisoni GB, Filippi M. Resting state fMRI in Alzheimer's disease: beyond the default mode network. Neurobiol Aging. 2012 Aug;33(8):1564-78. doi: 10.1016/j.neurobiolaging.2011.06.007. Epub 2011 Aug 3.

Results Reference

background

PubMed Identifier

8028666

Citation

Albert MS, Cates GD, Driehuys B, Happer W, Saam B, Springer CS Jr, Wishnia A. Biological magnetic resonance imaging using laser-polarized 129Xe. Nature. 1994 Jul 21;370(6486):199-201. doi: 10.1038/370199a0.

Results Reference

background

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

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