Novel MRI Biomarkers for Monitoring Disease Progression in ALS

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Primary Lateral Sclerosis (PLS), Healthy Volunteer

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Sanjay Kalra, MDFRCPC, University of Alberta

Clinicaltrials.gov ID (11 digit #):

NCT03362658

Neals Affiliated?

No

Coordinating Center Contact Information

University of Alberta
Dennell M Mah, BA / .(JavaScript must be enabled to view this email address) / 780-248-1805
.(JavaScript must be enabled to view this email address) Canada

Full Study Summary:

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.

Study Sponsor:

University of Alberta

Participant Duration:

8 months

Estimated Enrollment:

700

Estimated Study Start Date:

10/01/2016

Estimated Study Completion Date:

12/31/2020

Posting Last Modified Date:

01/05/2018

Date Study Added to alsconsortium.org:

01/05/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Patients with a 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.
    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 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, brain tumour).
    Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body.

  • Site Contact Information

    University of Calgary / Heritage Medical Research Clinic
    Victoria Hodgkinson / .(JavaScript must be enabled to view this email address) / 403-210-7303
    Calgary, Alberta T2N 4Z6
    Canada

    University of Alberta
    Dennell Mah, BA / .(JavaScript must be enabled to view this email address) / 780-248-1805
    Edmonton, Alberta T6G 2B7
    Canada

    University of British Columbia / GF Strong Rehab Centre
    Marife Fabros, RN / .(JavaScript must be enabled to view this email address) / 604-737-6319
    Vancouver, British Columbia V5Z 2G9
    Canada

    Western University / London Health Sciences Centre
    Christine Piechowicz / .(JavaScript must be enabled to view this email address) / 519-685-8500 ext 34858
    London, Ontario N6A 5A5
    Canada

    University of Toronto / Sunnybrook Health Sciences Centre
    Shirley Pham / .(JavaScript must be enabled to view this email address) / 416-480-5618
    Toronto, Ontario M4N 3M5
    Canada

    McGill University / Montreal Neurological Institute and Hospital
    Natalie Saunders / .(JavaScript must be enabled to view this email address) / 514-398-6526
    Montreal, Quebec H3A 2B4
    Canada

    Laval University
    Alexandra Simard, BSc / .(JavaScript must be enabled to view this email address) / 418-649-0252 ext 63559
    Quebec City, Quebec G1V 0A6
    Canada