Amyotrophic Lateral SclerosisNCT03362658
Novel MRI Biomarkers for Monitoring Disease Progression in ALS
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by University of Alberta at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- How many people
- 119 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients with a diagnosis of motor neuron disease (MND). This includes the diagnoses of amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA). 2. Patients with frontotemporal dementia (FTD) with or without motor neuron signs.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada5 sites
University of Calgary / Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6
University of Alberta
Edmonton, Alberta, T6G 2B7
McGill University / Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Laval University
Québec, Quebec, G1V 0A6
University of Toronto / Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
United States2 sites
University of Miami
Miami, Florida
University of Utah
Salt Lake City, Utah, 84108
About this study
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.
Read the 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 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.
- Keywords
- Magnetic Resonance Imaging, MRI, Biomarker
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | ALS patients (as well as patients with other related disorders such PLS, PMA, and ALS-FTD) will be recruited from ALS clinics under the direction of neurologists who are participating in this study. ALS patients should meet research criteria for suspected, possible, probable, probable laboratory supported, or definite ALS. | |
| Controls | Healthy controls who are age and gender matched to patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study startOct 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Western University, Canada, McGill University, University of Toronto, University of British Columbia, Laval University, University of Miami, University of Utah
- Responsible party
- Sponsor
- Investigators
- Sanjay Kalra, MD, Principal investigator, FRCPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362658
- Sponsor's protocol ID
- RES0027887
- Status last verified
- May 2026
- First submitted
- 18 Oct 2017
- Last updated
- 8 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel MRI Biomarkers for Monitoring Disease Progression in ALS
- ClinicalTrials.gov ID
- NCT03362658
- Acronym / sponsor ID
- RES0027887
- Keywords
- Magnetic Resonance Imaging, MRI, Biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary, Western University, Canada, McGill University, University of Toronto, University of British Columbia, Laval University, University of Miami, University of Utah
- Study start
- Oct 2016
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –ALS patients (as well as patients with other related disorders such PLS, PMA, and ALS-FTD) will be recruited from ALS clinics under the direction of neurologists who are participating in this study. ALS patients should meet research criteria for suspected, possible, probable, probable laboratory supported, or definite ALS. |
| Controls | – | –Healthy controls who are age and gender matched to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with a diagnosis of motor neuron disease (MND). This includes the diagnoses of amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA). 2. Patients with frontotemporal dementia (FTD) with or without motor neuron signs.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cortical thickness in millimetres.
Time frame: 8 months
This primary analysis will evaluate neuronal integrity at baseline and specified follow up periods. Patients and controls scans will be compared.
Change in DTI indices (unitless).
Time frame: 8 months
This primary analysis will evaluate white matter integrity at baseline and specified follow up periods. Patients and controls scans will be compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Kalra, MD principal investigator
FRCPC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by University of Alberta at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortical thickness in millimetres. (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.