What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine), can cause gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Aducanumab, a newer treatment, has been associated with amyloid-related imaging abnormalities (ARIA), including brain swelling and small brain bleeds, as well as headaches, falls, diarrhea, and confusion. Patients should discuss these potential side effects with their healthcare providers.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. Recently, aducanumab, a monoclonal antibody targeting amyloid-beta, was approved, marking a shift towards disease-modifying therapies. While these treatments primarily focus on symptom management and slowing disease progression, advanced imaging techniques like Hyperpolarized Xenon Functional Brain MRI are being studied to improve diagnostic accuracy and monitor treatment efficacy by providing enhanced sensitivity and resolution in brain imaging.

What other types of research exist?

Promising novel alternatives to Hyperpolarized Xenon Functional Brain MRI for Alzheimer's Disease patients in 2024 include: 1) PET/CT and PET/MRI using advanced radiotracers, which offer high sensitivity in detecting amyloid plaques and tau tangles. 2) Advanced MRI techniques such as 7-Tesla MRI, which provides higher resolution images of brain structures. 3) Functional MRI (fMRI) with improved protocols for better assessment of brain activity and connectivity. These alternatives can provide comprehensive insights into the brain's pathology and functional changes associated with Alzheimer's Disease.

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Xenon-129 fMRI for Alzheimer's Disease

Q: What is the mechanism of action of this treatment?

The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine in the brain, which helps improve communication between nerve cells and can provide modest symptomatic relief in cognition and global functioning. Memantine, on the other hand, regulates the activity of glutamate, a neurotransmitter involved in learning and memory, to prevent excessive neuronal damage. These treatments are crucial for AD patients as they can help manage symptoms and improve quality of life, even though they do not alter the disease's progression. Advanced imaging techniques like Hyperpolarized Xenon Functional Brain MRI can further aid in the precise monitoring of brain function and the effectiveness of these treatments, potentially leading to more personalized and effective therapeutic strategies.

Phase < 1

Waitlist Available

Led By Mitchell Albert, Ph.D.

Research Sponsored by Thunder Bay Regional Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal or corrected to normal vision

Participants meet National Institute on Aging-Alzheimer's Association for probable or possible Alzheimer's Disease dementia

Must not have

Female exclusion only: Are or may be pregnant; Planning on becoming pregnant

History of diagnosed neurological disease or injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct side effects mentioned from the imaging techniques used in this trial; however, participants should not be claustrophobic as they will be required to enter an MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My vision is normal or corrected to normal with glasses or contacts.

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I have been diagnosed with Alzheimer's Disease.

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I am between 60 and 85 years old and not breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant nor planning to become pregnant.

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I have been diagnosed with a neurological disease or have had a brain injury.

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My dementia is not caused by Alzheimer's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Signal-to-Noise Ratio (SNR)

Secondary study objectives

P-Value

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy VolunteersExperimental Treatment4 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 ParticipantsExperimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Xenon

Not yet FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine in the brain, which helps improve communication between nerve cells and can provide modest symptomatic relief in cognition and global functioning. Memantine, on the other hand, regulates the activity of glutamate, a neurotransmitter involved in learning and memory, to prevent excessive neuronal damage. These treatments are crucial for AD patients as they can help manage symptoms and improve quality of life, even though they do not alter the disease's progression. Advanced imaging techniques like Hyperpolarized Xenon Functional Brain MRI can further aid in the precise monitoring of brain function and the effectiveness of these treatments, potentially leading to more personalized and effective therapeutic strategies.

Imaging biomarkers and their role in dementia clinical trials.