Status:
RECRUITING
Novel MRI Biomarkers for Monitoring Disease Progression in ALS
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University of Calgary
Western University, Canada
Conditions:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Eligibility:
All Genders
18+ years
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, chem...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT03362658
Start Date
October 1 2016
End Date
December 31 2025
Last Update
February 28 2025
Active Locations (9)
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1
University of Miami
Miami, Florida, United States
2
University of Utah
Salt Lake City, Utah, United States, 84108
3
University of Calgary / Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6
4
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7