MRI Biomarkers for ALS

Recruiting at 7 trial locations

Overseen By Sara Moradipoor, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Major depressive disorder, Schizophrenia, Bipolar, Stroke, others

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

Compensation: Varies

Number of Visits: 4

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new MRI techniques to better understand and track ALS, a disease affecting the nerve cells that control muscles. By using these advanced MRI scans, researchers aim to find ways to diagnose ALS earlier and monitor its progression more effectively. The goal is also to improve the testing of new ALS treatments, potentially speeding up the discovery of a cure. Individuals with a suspected or confirmed diagnosis of ALS, who can comfortably undergo MRI scans, might be suitable for this study. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could lead to earlier diagnosis and better treatment options for ALS.

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 or your doctor.

What prior data suggests that these MRI techniques are safe for participants?

Research shows that MRI (magnetic resonance imaging) is a safe method because it doesn't use radiation. In past studies, researchers used MRI scans to study ALS (amyotrophic lateral sclerosis) without harming participants. These studies examined changes in the brain and tracked ALS progression. Participants did not experience any major side effects from the MRI scans.

Hospitals widely use MRI for many conditions because people generally tolerate it well. This makes it a reliable choice for studying ALS and finding new ways to diagnose and monitor the disease. Participants in this trial will undergo a few MRI scans over several months, which previous research has considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI biomarkers to monitor ALS progression because this approach offers a non-invasive and detailed way to track the disease's impact on the brain and spinal cord. Unlike traditional methods that might rely on clinical assessments or invasive procedures, MRI biomarkers can provide real-time insights into the disease's progression without discomfort to the patient. This technique has the potential to revolutionize how we understand and manage ALS by offering a clearer picture of how the disease affects the nervous system over time.

What evidence suggests that these MRI techniques are effective for understanding and diagnosing ALS?

Research shows that advanced MRI scans can enhance the understanding and tracking of ALS. These imaging techniques can identify specific brain changes linked to ALS, leading to earlier diagnosis and improved disease monitoring. For example, muscle MRI serves as a useful tool for monitoring ALS, potentially making clinical trials quicker and smaller. These MRI markers offer a clear way to measure how ALS affects the brain's structure and function over time. By providing a better view of these changes, MRI markers can improve the testing and development of new ALS treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Sanjay Kalra, MD

Principal Investigator

FRCPC

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with a suspected or confirmed diagnosis as described in Study Populations

For those with a diagnosis of ALS, patients will be considered with an El Escorial classification of suspected, possible, probable, probable lab-supported, and definite ALS.

Healthy controls over the age of 40.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial MRI scan and neurological and cognitive evaluations

1 visit

1 visit (in-person)

Monitoring

Participants undergo 3 MRI scans over 8 months to monitor disease progression

8 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI Biomarkers

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Laval University

Collaborator

Trials

439

Recruited

178,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Citations

1. jnnp.bmj.com jnnp.bmj.com/content/96/9/908

Muscle MRI quantifies disease progression in amyotrophic ... Muscle MRI has the potential to be utilised as a biomarker for ALS disease progression and could contribute to reducing the size and duration of clinical trials ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6209630/

Imaging Biomarkers for the Diagnosis and Prognosis of ... In this review, the characteristics of an optimal imaging biomarker and common pitfalls in biomarkers evaluation will be discussed.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04691011

New Magnetic Resonance Imaging Biomarkers in ... These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression ...

4. frontiersin.org frontiersin.org/journals/molecular-biosciences/articles/10.3389/fmolb.2025.1608853/full

Emerging biomarkers in amyotrophic lateral sclerosis In this review, we have summarized recent developments in ALS biomarker studies, focusing on neurofilaments in each biofluid, transcriptomic signatures, and ...

5. molecularneurodegeneration.biomedcentral.com molecularneurodegeneration.biomedcentral.com/articles/10.1186/s13024-023-00685-6

Fluid biomarkers for amyotrophic lateral sclerosis: a review These data suggest that fluid neurofilament concentrations may facilitate a more rapid and accurate ALS diagnosis. Nevertheless, incorporating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6288231/

Developing a Neuroimaging Biomarker for Amyotrophic ... This review will use the example of the Neuroimaging Society in ALS (NiSALS) to discuss the set-up of a multi-center data sharing ecosystem.

7. academicradiology.org academicradiology.org/article/S1076-6332(17)30328-8/fulltext

MR Imaging Biomarkers in Amyotrophic Lateral Sclerosis Their interesting results showed significantly higher signal intensity in patients compared to controls, increased accuracy of patient subgroup classification ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S187874792301509X

Neuroimaging Endpoints in Amyotrophic Lateral Sclerosis MRI is unique in being able to assess simultaneously brain structure and function, and provide a deeper understanding of in vivo evolution of cerebral pathology ...