Amyotrophic Lateral SclerosisCAPTURE ALSNCT05204017
Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS
An observational study of Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis, run by University of Alberta at 4 sites in Canada.
Trial summary
CAPTURE ALS is a long-term data and biorepository platform that will facilitate future ALS research. CAPTURE ALS will provide the standardized systems and tools necessary to collect, store, and analyze vast amounts of multimodal information about ALS. 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, Primary Lateral Sclerosis, Progressive Muscular Atrophy
- How many people
- 150 participants
- Where
- 4 sitesCanada
- Study dates
- 12 Sep 2021to Dec 2031
- 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: People living with ALS and related motor neuron diseases including ALS-Frontotemporal Dementia (ALS-FTD), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA) and asymptomatic individuals with a known ALS mutation AND Healthy controls that are age and sex matched to patients
Who may be able to join
- Has ALS, classified as definite, probable, laboratory-supported probable, or possible ALS according to the revised El Escorial criteria or a related neurodegenerative disorder including ALS-FTD, PLS, PMA or asymptomatic individuals with a known ALS mutation (as previously confirmed during regular clinical care)
- Be of the age of majority in their province of residence/treatment
- Have the cognitive capacity to provide informed consent
- Have proficiency in English or French in order to understand study instructions and respond to questionnaires
- Be between the ages of 40-80 unless age matched to a patient (+/-3 years) who is already enrolled
- Be the age of majority in their province of residence/treatment
- Have the cognitive capacity to provide informed consent
- Have proficiency in English of French to understand study instructions and respond to questionnaires
Who cannot join
- N/A
- [HEALTHY CONTROLS]
- A history of a neurological disease, including Central Nervous System disease (e.g., stroke, head injury, epilepsy) or Peripheral Nervous System disease (neuropathy, myopathy)
- A history of psychiatric disease (e.g. depression, bipolar disease) that is clinically diagnosed and/or with the current use of psychiatric medications (e.g. antidepressants) for an indication of a psychiatric disease.
- Subjects ineligible for an MRI due to a pacemaker or other contraindication according to local MRI policies of the study centre.
- Significant claustrophobia that would prohibit an MRI (subjects will be required to lie in an MRI scanner for approximately one hour).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2B7
- Recruiting
McGill University / Montreal Neurological Institute and Hospital
Montreal, Quebec, H4A2H6
- Recruiting
CHU de Quebec -Universite de Laval
Québec, Quebec, G1J 1Z
- Recruiting
University of Toronto / Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
CAPTURE ALS is a long-term data and biorepository platform that will facilitate future ALS research. CAPTURE ALS will provide the standardized systems and tools necessary to collect, store, and analyze vast amounts of multimodal information about ALS. These multimodal datasets and biosamples will be made available for use by researchers or industry across Canada and around the world in accordance with the CAPTURE ALS Data Sharing Policy to advance research on ALS.
Read the detailed description
In this observational study, participants with ALS and related disorders will be followed longitudinally over the course of a year to examine disease progression. Participants with ALS or a related disorder will have up to 5 in-person visits at screening, 0, 4, 8 and 12 months. Healthy controls are included as comparisons and will have 3 in-person visits at screening, 0 and 8 months. At each visit after screening, patients and healthy controls will undergo an MRI, neurocognitive and speech testing, clinical evaluations specific to ALS (ALSFRS-R, FVC, neurological exam, which are not completed by controls), answer questionnaires about their health and have biospecimens, including blood, saliva and optionally cerebrospinal fluid, collected.
- Conditions
- Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy, Frontotemporal Degeneration
- Keywords
- Biomarker, Biorepository, ALS, Disease Progression, MRI, Biofluids
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Muscular Atrophy, Spinal, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS Functional Rating Scale-Revised (ALSFRS-R)
The ALSFRS-R will be used as a global measure of disease status. It measures activities of daily living and consists of 12 questions, each scored from 0-4, with higher scores representing better function. Changes in ALSFRS-R score over time will be measured.
Measured: Once every 4 months for a year
Forced Vital Capacity (FVC)
FVC will be used as an index of respiratory function over time. FVC is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration.
Measured: Once every 4 months for a year
Speech Testing
Changes in speech function over time will be measured using a web-browser based audio and video data collection tool.
Measured: Once every 4 months for a year
Neurological dysfunction as detected during standard neurological examination
Changes in neurological function over time will be measured through a standard neurological examination.
Measured: Once every 4 months for a year
Magnetic Resonance Imaging (MRI)
Various advanced MRI techniques will be used to assess nervous system structure and function.
Measured: Once every 4 months for a year
Edinburgh Cognitive and Behavioural Screen (ECAS)
Changes in cognitive function over time will be measured by the ECAS.
Measured: Once every 4 months for a year
ALS Assessment Questionnaire (ALSAQ-5)
Changes in quality of life over time will be measured using the ALSAQ-5, a participant reported outcome measure.
Measured: Once every 4 months for a year
World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF)
Changes in quality of life over time will be measured using the WHO-QOL-BREF, a participant reported outcome measure.
Measured: Once every 4 months for a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start12 Sep 2021
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Laval University, University of Toronto, Simon Fraser University
- Responsible party
- Sponsor
- Investigators
- Sanjay Kalra, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204017
- Sponsor's protocol ID
- Pro00110972
- Acronym
- CAPTURE ALS
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saunders N, Magnussen C, Kang H, Blais M, Bhinder H, Pfeffer G, Genuis SK, Bouvier L, Anand T, Abou-Haidar R, Abrahao A, Boivin MN, Bowser R, Bubela T, Chiappini J, Das S, Dhanoa A, Dupre N, Evans A, Ferry N, Frater Y, Genge A, Graham SJ, Greiner R, Medina YI, Johnston WS, Jones KE, Karamchandani J, Kriz J, Luth W, Matte G, Rogaeva E, Robertson J, Seres P, Tam F, Taylor D, Tremblay-Desbiens C, Velde CV, Yunusova Y, Zinman L, Kalra S. Comprehensive analysis platform to understand, remedy, and eliminate amyotrophic lateral sclerosis (CAPTURE ALS): Study protocol for a Canadian multicenter, multimodal, longitudinal observational study. PLoS One. 2025 Dec 4;20(12):e0332430. doi: 10.1371/journal.pone.0332430. eCollection 2025.
PubMed 41343582
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS
- ClinicalTrials.gov ID
- NCT05204017
- Acronym / sponsor ID
- CAPTURE ALS / Pro00110972
- Conditions
- Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy, Frontotemporal Degeneration
- Keywords
- Biomarker, Biorepository, ALS, Disease Progression, MRI, Biofluids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- McGill University, Laval University, University of Toronto, Simon Fraser University
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 24 Jan 2022 (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.
CAPTURE ALS is a long-term data and biorepository platform that will facilitate future ALS research. CAPTURE ALS will provide the standardized systems and tools necessary to collect, store, and analyze vast amounts of multimodal information about ALS. These multimodal datasets and biosamples will be made available for use by researchers or industry across Canada and around the world in accordance with the CAPTURE ALS Data Sharing Policy to advance research on ALS.
Detailed description
In this observational study, participants with ALS and related disorders will be followed longitudinally over the course of a year to examine disease progression. Participants with ALS or a related disorder will have up to 5 in-person visits at screening, 0, 4, 8 and 12 months. Healthy controls are included as comparisons and will have 3 in-person visits at screening, 0 and 8 months. At each visit after screening, patients and healthy controls will undergo an MRI, neurocognitive and speech testing, clinical evaluations specific to ALS (ALSFRS-R, FVC, neurological exam, which are not completed by controls), answer questionnaires about their health and have biospecimens, including blood, saliva and optionally cerebrospinal fluid, collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People living with ALS and related motor neuron diseases including ALS-Frontotemporal Dementia (ALS-FTD), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA) and asymptomatic individuals with a known ALS mutation AND Healthy controls that are age and sex matched to patients
Key inclusion criteria (8 listed)
- Has ALS, classified as definite, probable, laboratory-supported probable, or possible ALS according to the revised El Escorial criteria or a related neurodegenerative disorder including ALS-FTD, PLS, PMA or asymptomatic individuals with a known ALS mutation (as previously confirmed during regular clinical care)
- Be of the age of majority in their province of residence/treatment
- Have the cognitive capacity to provide informed consent
- Have proficiency in English or French in order to understand study instructions and respond to questionnaires
- Be between the ages of 40-80 unless age matched to a patient (+/-3 years) who is already enrolled
Key exclusion criteria (6 listed)
- N/A
- [HEALTHY CONTROLS]
- A history of a neurological disease, including Central Nervous System disease (e.g., stroke, head injury, epilepsy) or Peripheral Nervous System disease (neuropathy, myopathy)
- A history of psychiatric disease (e.g. depression, bipolar disease) that is clinically diagnosed and/or with the current use of psychiatric medications (e.g. antidepressants) for an indication of a psychiatric disease.
- Subjects ineligible for an MRI due to a pacemaker or other contraindication according to local MRI policies of the study centre.
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
ALS Functional Rating Scale-Revised (ALSFRS-R)
Time frame: Once every 4 months for a year
The ALSFRS-R will be used as a global measure of disease status. It measures activities of daily living and consists of 12 questions, each scored from 0-4, with higher scores representing better function. Changes in ALSFRS-R score over time will be measured.
Forced Vital Capacity (FVC)
Time frame: Once every 4 months for a year
FVC will be used as an index of respiratory function over time. FVC is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration.
Speech Testing
Time frame: Once every 4 months for a year
Changes in speech function over time will be measured using a web-browser based audio and video data collection tool.
Neurological dysfunction as detected during standard neurological examination
Time frame: Once every 4 months for a year
Changes in neurological function over time will be measured through a standard neurological examination.
Magnetic Resonance Imaging (MRI)
Time frame: Once every 4 months for a year
Various advanced MRI techniques will be used to assess nervous system structure and function.
Edinburgh Cognitive and Behavioural Screen (ECAS)
Time frame: Once every 4 months for a year
Changes in cognitive function over time will be measured by the ECAS.
ALS Assessment Questionnaire (ALSAQ-5)
Time frame: Once every 4 months for a year
Changes in quality of life over time will be measured using the ALSAQ-5, a participant reported outcome measure.
World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF)
Time frame: Once every 4 months for a year
Changes in quality of life over time will be measured using the WHO-QOL-BREF, a participant reported outcome measure.
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 13 Apr 2026.
- Derived from this study: PubMed 41343582Saunders N, Magnussen C, Kang H, Blais M, Bhinder H, Pfeffer G, Genuis SK, Bouvier L, Anand T, Abou-Haidar R, Abrahao A, Boivin MN, Bowser R, Bubela T, Chiappini J, Das S, Dhanoa A, Dupre N, Evans A, Ferry N, Frater Y, Genge A, Graham SJ, Greiner R, Medina YI, Johnston WS, Jones KE, Karamchandani J, Kriz J, Luth W, Matte G, Rogaeva E, Robertson J, Seres P, Tam F, Taylor D, Tremblay-Desbiens C, Velde CV, Yunusova Y, Zinman L, Kalra S. Comprehensive analysis platform to understand, remedy, and eliminate amyotrophic lateral sclerosis (CAPTURE ALS): Study protocol for a Canadian multicenter, multimodal, longitudinal observational study. PLoS One. 2025 Dec 4;20(12):e0332430. doi: 10.1371/journal.pone.0332430. eCollection 2025.
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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.
Sanjay Kalra, MD principal investigator
University of Alberta
4 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 Primary Lateral Sclerosis, run by University of Alberta at 4 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Contact Claire Magnussen, PhD (514-398-6188, info@captureals.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Functional Rating Scale-Revised (ALSFRS-R) (time frame: Once every 4 months for a year). The study lists 8 primary outcomes in all. 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 NCT05204017, which also lists 1 linked publication.
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 13 Apr 2026.