Novel MRI Biomarkers for Monitoring Disease Progression in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Novel MRI Biomarkers for Monitoring Disease Progression in ALS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03362658
• Other study ID #: RES0027887
• Status: Recruiting
• Start date: October 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Alberta
• Contact: Sara Moradipoor, MSc
• Phone: 780-248-1805
• Email: moradipo[@]ualberta.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Disease Progression
• Motor Neuron Disease

Locations

Country	Name	City	State
Canada	University of Calgary / Heritage Medical Research Clinic	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Western University / London Health Sciences Centre	London	Ontario
Canada	McGill University / Montreal Neurological Institute and Hospital	Montreal	Quebec
Canada	Laval University	Quebec City	Quebec
Canada	University of Toronto / Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University of British Columbia / GF Strong Rehab Centre	Vancouver	British Columbia
United States	University of Miami	Miami	Florida
United States	University of Utah	Salt Lake City	Utah

Sponsors (9)

Lead Sponsor	Collaborator
University of Alberta	Laval University, McGill University, University of British Columbia, University of Calgary, University of Miami, University of Toronto, University of Utah, Western University, Canada

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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