Xenon-129 fMRI for Alzheimer's Disease

Overseen By Alla Reznik, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Thunder Bay Regional Health Research Institute

Disqualifiers: Substance abuse, Psychotic disorder, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a special MRI scan with a gas called xenon-129 to get clearer pictures of the brain. It targets people being assessed for brain function to help develop better treatments for Alzheimer's disease. Participants will inhale the gas during the scan, which helps create very detailed images of their brain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for clarification.

Is hyperpolarized xenon-129 MRI safe for humans?

Research on hyperpolarized xenon-129 MRI, including studies on healthy volunteers and patients with chronic obstructive pulmonary disease, suggests that inhaling this gas for imaging is generally safe and well-tolerated. ^{1 2 3 4 5}

How does Xenon-129 fMRI differ from other treatments for Alzheimer's disease?

Xenon-129 fMRI is unique because it uses a special type of MRI that involves inhaling xenon gas to study brain function, offering a non-invasive way to observe changes in brain activity and structure over time, which is different from traditional drug treatments that focus on altering brain chemistry. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment 1H-129Xe Dual-Tuned Quadrature Head Coil, Hyperpolarized Xenon-129 for Alzheimer's Disease?

The research suggests that using advanced MRI techniques like calibrated fMRI can help understand Alzheimer's disease by measuring brain blood flow and metabolism, which are affected in the condition. This approach, similar to the one used in the trial, shows promise in monitoring therapeutic responses and could be useful in future clinical trials for Alzheimer's. ^{7 11 12 13 14}

Who Is on the Research Team?

Mitchell Albert, Ph.D.

Principal Investigator

Thunder Bay Regional Health Research Institute

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with Alzheimer's disease, aged 18-85 or 60-85 respectively. Participants must speak English, have at least 8 years of education, be able to consent and hold their breath for 20 seconds. Those with Alzheimer's need a MoCA score of at least 16 and a caregiver present during the study.

Inclusion Criteria

MoCA score no less than 16

Have a family member, close friend, or LAR that can be present for the informed consent process and study visits

Self-reported proficiency in English language

Exclusion Criteria

I am not pregnant nor planning to become 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Imaging

Participants undergo MRI scanning using traditional proton fMRI and hyperpolarized xenon-129 fMRI

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 1H-129Xe Dual-Tuned Quadrature Head Coil
• Hyperpolarized Xenon-129

Trial Overview The study tests hyperpolarized xenon functional brain MRI against traditional proton fMRI in detecting brain function changes in Alzheimer's. It aims to improve drug development by providing more sensitive measurements of brain activity.

How Is the Trial Designed?

Group I: Healthy Volunteers Experimental Treatment 4 Interventions

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.

Group II: Alzheimer's Disease Participants Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Thunder Bay Regional Health Research Institute

Lead Sponsor

Trials

11

Recruited

860+

Thunder Bay Regional Research Institute

Lead Sponsor

Trials

9

Recruited

620+

Thunder Bay Regional Health Sciences Centre

Collaborator

Trials

10

Recruited

3,300+

Lakehead University

Collaborator

Trials

29

Recruited

3,900+

Published Research Related to This Trial

Inhalation of hyperpolarized xenon-129 (129Xe) was found to be safe and well tolerated among 44 subjects, including healthy individuals and patients with chronic obstructive pulmonary disease (COPD), with no serious adverse events reported.

While 91% of participants experienced mild and transient symptoms such as dizziness and euphoria, these symptoms resolved quickly without the need for clinical intervention, indicating that the procedure is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Driehuys, B., Martinez-Jimenez, S., Cleveland, ZI., et al.[2022]

Functional MRI (fMRI) is a safe and noninvasive imaging tool that allows for repeated scans, making it ideal for studying brain activation in patients with neurological and neuropsychiatric disorders over time.

fMRI has shown potential in identifying abnormal brain activity, understanding neuroplasticity, and serving as a predictive biomarker for disease progression, highlighting its utility in both clinical trials and basic research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in functional magnetic resonance imaging: technology and clinical applications. Dickerson, BC.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Pattern of cerebral hypoperfusion in Alzheimer disease and mild cognitive impairment measured with arterial spin-labeling MR imaging: initial experience. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Test-retest reliability of memory task functional magnetic resonance imaging in Alzheimer disease clinical trials. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Application of calibrated fMRI in Alzheimer's disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Voxel-level comparison of arterial spin-labeled perfusion MRI and FDG-PET in Alzheimer disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impaired cerebral vasoreactivity to CO2 in Alzheimer's disease using BOLD fMRI. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Dissolved hyperpolarized xenon-129 MRI in human kidneys. [2021]

8. England pubmed.ncbi.nlm.nih.gov

MRI of stroke using hyperpolarized 129Xe. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Distribution of hyperpolarized xenon in the brain following sensory stimulation: preliminary MRI findings. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of an initial depolarization pulse on dissolved phase hyperpolarized 129 Xe brain MRI. [2022]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Application of multimodal MR imaging on studying Alzheimer's disease: a survey. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Mapping oxidative metabolism in the human brain with calibrated fMRI in health and disease. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Advances in functional magnetic resonance imaging: technology and clinical applications. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Functional MRI using molecular imaging agents. [2022]