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.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis , Motor Neuron Disease

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

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

Sanjay Kalra, MD, FRCPC

Clinicaltrials.gov ID:

NCT03362658

Neals Affiliated?

No

Coordinating Center Contact Information

University of Alberta

Sara Moradipoor, MSc / email hidden; JavaScript is required / 780-248-1805

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 / 01 / 2023

Posting Last Modified Date:

01 / 26 / 2023

Date Study Added to neals.org:

12 / 05 / 2017

Minimum Age:

18 Years

Maximum Age:

N/A

Can participants use Riluzole?

Yes

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.

- 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.

University of Miami | Recruiting

Anna Thompson / 305-243-7613 / email hidden; JavaScript is required

Miami, Florida
United States

University of Utah | Recruiting

Robert Welsh / email hidden; JavaScript is required

Salt Lake City, Utah 84108
United States

University of Calgary / Heritage Medical Research Clinic | Recruiting

Victoria Hodgkinson / 403-210-7303 / email hidden; JavaScript is required

Janet Petrillo / 403-210-7006 / email hidden; JavaScript is required

Calgary, Alberta T2N 4Z6
Canada

University of Alberta | Recruiting

Sara Moradipoor, MSc / 780-248-1805 / email hidden; JavaScript is required

Edmonton, Alberta T6G 2B7
Canada

University of British Columbia / GF Strong Rehab Centre | Withdrawn

Vancouver, British Columbia V5Z 2G9
Canada

Western University / London Health Sciences Centre | Withdrawn

London, Ontario N6A 5A5
Canada

University of Toronto / Sunnybrook Health Sciences Centre | Recruiting

Shirley Pham / 416-480-5618 / email hidden; JavaScript is required

Toronto, Ontario M4N 3M5
Canada

McGill University / Montreal Neurological Institute and Hospital | Recruiting

Natalie Saunders / 514-398-6526 / email hidden; JavaScript is required

Smita Patel / 514-398-1779 / email hidden; JavaScript is required

Montreal, Quebec H3A 2B4
Canada

Laval University | Recruiting

Alexandra Simard, BSc / 418-649-0252 Ext. 63559 / email hidden; JavaScript is required

Quebec City, Quebec G1V 0A6
Canada