- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405182
MRI Biomarkers in ALS
Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Increasing age is an important risk factor for developing ALS; thus, the societal impact of this devastating disease will become more profound as the population ages. A significant hurdle to finding effective treatment has been an inability to accurately measure brain degeneration in humans. Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect, and may assist in aiding diagnosis and the efficient testing of new drugs.
Different MRI features of brain degeneration will be measured in a large sample of patients with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC). CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical and neuroimaging protocols.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will use advanced Magnetic Resonance Imaging (MRI) techniques to measure brain changes in ALS and related neurological conditions. Results from cognitive and neurological tests will be compared to the MRI. It is believed that these techniques will reveal changes in the brain that will help us understand normal brain function and the symptoms of neurological diseases as seen in ALS, as well to provide an objective measurement of degeneration (which is called a biomarker). This could improve not only the process by which new drugs for the treatment of neurological diseases are evaluated, but also how health care professionals address the needs of patients with these diseases.
Furthermore, a biomarker may give insight into the biological factors related to the diverse and variable clinical features amongst different patients.
Subjects will be recruited from ALS clinics that are a part of the Canadian ALS Neuroimaging Consortium (CALSNIC). Patients will have a diagnosis of ALS, PLS, PMA, or FTD. Healthy controls will be age and gender matched to patients. Subjects will visit their respective sites to undergo a clinical evaluation and an MRI. Follow up visits will occur at approximately 3-6 month intervals. Most subjects will have 2 follow up visits; more visits may occur for subjects who are physically able to continue in the protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary / Heritage Medical Research Clinic
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 2G9
- University of British Columbia / GF Strong Rehab Centre
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Ontario
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London, Ontario, Canada, N6A 5A5
- Western University / London Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- University of Toronto / Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3A 2B4
- McGill University / Montreal Neurological Institute and Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients will be adults with a diagnosis of motor neuron disease (MND), including those with ALS, PLS, and PMA, and as well frontotemporal dementia (FTD) without motor neuron signs.
- Healthy controls over the age of 40 will also be recruited and will be age- and gender-matched to patients.
Exclusion Criteria:
- Subjects with other psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder, and those with significant head injury.
- Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.
These exclusion criteria will also apply to controls.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
ALS patients (as well as patients with other motor neuron diseases such PLS and PMA) will be recruited from ALS clinics under the direction of ALS neurologists who are participating in this study.
ALS patients should meet research criteria for possible, probable, probable laboratory-supported, or definite ALS.
Patients with a history of CNS disease (e.g.
stroke, head injury) or significant psychiatric disease will be ineligible.
Patients must be able to undergo a brain MRI for approximately an hour.
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Other Names:
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Controls
Healthy controls who are age and gender matched to patients will be recruited.
Controls with a history of CNS disease (e.g.
stroke, head injury) or significant psychiatric disease will be ineligible.
Controls must be able to undergo a brain MRI for approximately an hour.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in neuronal and white matter integrity measures.
Time Frame: 24 months
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The primary analysis will evaluate changes in the brain using various advanced MRI techniques at baseline and specified follow up periods.
Patients and controls scans will be compared.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of neuronal and white matter integrity measures with clinical indices.
Time Frame: 30 months
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Secondary analyses will involve MRI comparison to clinical measures both at the time of the baseline scan and over time.
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30 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sanjay Kalra, MD, FRCPC, University of Alberta
Publications and helpful links
General Publications
- Ta D, Ishaque A, Srivastava O, Hanstock C, Seres P, Eurich DT, Luk C, Briemberg H, Frayne R, Genge AL, Graham SJ, Korngut L, Zinman L, Kalra S. Progressive Neurochemical Abnormalities in Cognitive and Motor Subgroups of Amyotrophic Lateral Sclerosis: A Prospective Multicenter Study. Neurology. 2021 Aug 24;97(8):e803-e813. doi: 10.1212/WNL.0000000000012367. Epub 2021 Jun 14.
- Kalra S, Muller HP, Ishaque A, Zinman L, Korngut L, Genge A, Beaulieu C, Frayne R, Graham SJ, Kassubek J. A prospective harmonized multicenter DTI study of cerebral white matter degeneration in ALS. Neurology. 2020 Aug 25;95(8):e943-e952. doi: 10.1212/WNL.0000000000010235. Epub 2020 Jul 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RES0013831
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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