Novel MRI Biomarkers for Monitoring Disease Progression in ALS

Last updated: February 27, 2025
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

N/A

Clinical Study ID

NCT03362658
RES0027887
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques can provide an objective measure of degeneration (a "biomarker") by examining brain structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques that could improve our understanding of ALS and provide a means to diagnose it sooner and monitor its progression. Importantly, we expect these techniques to improve how new drugs are tested, which may lead to the more rapid discovery of a treatment for ALS.

Each participant will have 3 MRI scans over a period of 8 months, along with neurological and cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does not involve radiation.

Eligibility Criteria

Inclusion

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 Escorialclassification of suspected, possible, probable, probable lab-supported, anddefinite ALS.

  • Patients 18 years of age or older

  • Healthy controls over the age of 40.

  • Be able to lie in an MRI machine for approximately 60 minutes

Exclusion

Exclusion Criteria:

  • Subjects with psychiatric/CNS illnesses such as Major Depressive Disorder,Schizophrenia, and Bipolar disorder.

  • Subjects with significant head injury or other neurological disease (stroke, braintumour).

  • Subjects ineligible for MRI investigation due to a pacemaker or other metallicforeign body.

Study Design

Total Participants: 700
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2025

Study Description

Current clinical measures of disease burden have suboptimal sensitivity to disease progression in ALS. A biomarker would play an essential role in the evaluation of novel therapeutics, leading to the realization of effective treatments faster. Magnetic resonance imaging (MRI) holds promise as a non-invasive source of biomarkers in ALS. In this study data is collected from a national imaging platform (the Canadian ALS Neuroimaging Consortium [CALSNIC]) using standardized MRI and clinical protocols.

CALSNIC was founded with the objective to validate MRI biomarkers on a standardized multi-centre platform. CALSNIC is a multidisciplinary group of scientists at 7 centres across Canada. The first CALSNIC study entitled "MRI Biomarkers in ALS" (CALSNIC-1) is ongoing and slated to finish recruitment in 2017.

This study ("Novel MRI Biomarkers for Monitoring Disease Progression in ALS", CALSNIC-2) is a new project that will evaluate novel MRI biomarkers using advanced imaging acquisition and processing methods. The specific aims of CALSNIC-2 are 1) to establish a standardized MRI and clinical protocol across the 7 centres, and 2) to validate MRI measures with clinical measures of disease burden and progression.

It is anticipated that the project will lead to the discovery of MR-based biomarkers of cerebral degeneration that can be applied across different centres and hence, can assist with drug development. Secondly, this project will expand CALSNIC to include more centres and provide opportunities for collaborative and multidisciplinary translational research on a national scale.

Connect with a study center

  • University of Calgary / Heritage Medical Research Clinic

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • University of Alberta

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • University of British Columbia / GF Strong Rehab Centre

    Vancouver, British Columbia V5Z 2G9
    Canada

    Site Not Available

  • Western University / London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • University of Toronto / Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • McGill University / Montreal Neurological Institute and Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

  • Laval University

    Quebec City, Quebec G1V 0A6
    Canada

    Active - Recruiting

  • University of Miami

    Miami, Florida
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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