Novel MRI Biomarkers for Monitoring Disease Progression in ALS
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/16/2018 |
| Start Date: | October 2016 |
| End Date: | December 2020 |
| Contact: | Dennell M Mah, BA |
| Email: | dennell.mah@ualberta.ca |
| Phone: | 780-248-1805 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
University of Miami A private research university with more than 15,000 students from around the...
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