Amyotrophic Lateral SclerosisNCT02405182
MRI Biomarkers in ALS
An observational study of Amyotrophic Lateral Sclerosis and ALS, run by University of Alberta at 6 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Diseases
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 145 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2014to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited predominantly from ALS clinics at: the University of Alberta Hospital in Edmonton; the Foothills Medical Centre in Calgary; the Sunnybrook Health Sciences Centre in Toronto; the London Health Sciences Centre in London; and the Montreal Neurological Hospital in Montreal.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Calgary / Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6
University of Alberta
Edmonton, Alberta, T6G 2B7
Western University / London Health Sciences Centre
London, Ontario, N6A 5A5
McGill University / Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
University of Toronto / Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University of British Columbia / GF Strong Rehab Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: 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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Diseases
- Being tested
- Magnetic Resonance Imaging
- 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.
Magnetic Resonance ImagingOther
Also called MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Magnetic Resonance Imaging | |
| 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. Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuronal and white matter integrity measures.
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.
Measured: 24 months
Secondary outcomes (1)
Correlation of neuronal and white matter integrity measures with clinical indices.
Secondary analyses will involve MRI comparison to clinical measures both at the time of the baseline scan and over time.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- 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
- 145 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
- Responsible party
- Principal investigator, Sanjay Kalra, University of Alberta
- Investigators
- Sanjay Kalra, MD, FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405182
- Sponsor's protocol ID
- RES0013831
- Status last verified
- Dec 2020
- First submitted
- 27 Feb 2015
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34426551Kalra 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.
PubMed 32646955
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02405182
- Acronym / sponsor ID
- RES0013831
- Conditions
- Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Diseases
- Keywords
- Magnetic Resonance Imaging, MRI, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary, Western University, Canada, McGill University, University of Toronto
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Magnetic Resonance ImagingALS 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. |
| Controls | – | Other: Magnetic Resonance ImagingHealthy 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited predominantly from ALS clinics at: the University of Alberta Hospital in Edmonton; the Foothills Medical Centre in Calgary; the Sunnybrook Health Sciences Centre in Toronto; the London Health Sciences Centre in London; and the Montreal Neurological Hospital in Montreal.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRI | Other | Controls, Patients |
Primary outcome
Change in neuronal and white matter integrity measures.
Time frame: 24 months
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.
1 secondary outcome
Correlation of neuronal and white matter integrity measures with clinical indices.
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Derived from this study: PubMed 34426551Ta 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.
- Derived from this study: PubMed 32646955Kalra 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.
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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, FRCPC principal investigator
University of Alberta
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and ALS, run by University of Alberta at 6 sites in Canada.
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 2 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: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 neuronal and white matter integrity measures. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405182, which also lists 2 linked publications.
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 7 Dec 2020.