Novel MRI Biomarkers for Monitoring Disease Progression in ALS

NCT03362658 | Active Not Recruiting

• 1 other identifier: RES0027887
• Study Type: observational
• Target: 119
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Keywords

Magnetic Resonance Imaging; MRI; Biomarker

Outcome Measures

Primary Outcomes (2)

• Change in cortical thickness in millimetres.

  This primary analysis will evaluate neuronal integrity at baseline and specified follow up periods. Patients and controls scans will be compared.

  8 months

• Change in DTI indices (unitless).

  This primary analysis will evaluate white matter integrity at baseline and specified follow up periods. Patients and controls scans will be compared.

  8 months

Study Arms (2)

Patients

ALS patients (as well as patients with other related disorders such PLS, PMA, and ALS-FTD) will be recruited from ALS clinics under the direction of neurologists who are participating in this study. ALS patients should meet research criteria for suspected, possible, probable, probable laboratory supported, or definite ALS.

Controls

Healthy controls who are age and gender matched to patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with a diagnosis of motor neuron disease (MND). This includes the diagnoses of amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA). 2. Patients with frontotemporal dementia (FTD) with or without motor neuron signs.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator
• Western University, Canada: collaborator
• Laval University: collaborator
• McGill University: collaborator
• University of Toronto: collaborator
• University of British Columbia: collaborator
• University of Miami: collaborator
• University of Utah: collaborator

Study Sites (7)

University of Miami

Miami, Florida, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Calgary / Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Toronto / Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

McGill University / Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sanjay Kalra, MD

  FRCPC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: December 5, 2017
• Study Start: October 1, 2016
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (2); CA (5)