Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS (CAPTURE ALS)

April 7, 2026 updated by: University of Alberta
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • University of Toronto / Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A2H6
        • Recruiting
        • McGill University / Montreal Neurological Institute and Hospital
      • Québec, Quebec, Canada, G1J 1Z
        • Recruiting
        • CHU de Quebec -Universite de Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

[PATIENTS]

Inclusion Criteria:

  1. 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)
  2. Be of the age of majority in their province of residence/treatment
  3. Have the cognitive capacity to provide informed consent
  4. Have proficiency in English or French in order to understand study instructions and respond to questionnaires

Exclusion Criteria:

N/A

[HEALTHY CONTROLS]

Inclusion Criteria:

  1. Be between the ages of 40-80 unless age matched to a patient (+/-3 years) who is already enrolled
  2. Be the age of majority in their province of residence/treatment
  3. Have the cognitive capacity to provide informed consent
  4. Have proficiency in English of French to understand study instructions and respond to questionnaires

Exclusion Criteria:

  1. A history of a neurological disease, including Central Nervous System disease (e.g., stroke, head injury, epilepsy) or Peripheral Nervous System disease (neuropathy, myopathy)
  2. 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.
  3. Subjects ineligible for an MRI due to a pacemaker or other contraindication according to local MRI policies of the study centre.
  4. Significant claustrophobia that would prohibit an MRI (subjects will be required to lie in an MRI scanner for approximately one hour).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once every 4 months for a year
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.
Once every 4 months for a year
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.
Once every 4 months for a year
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.
Once every 4 months for a year
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.
Once every 4 months for a year
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.
Once every 4 months for a year
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.
Once every 4 months for a year
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.
Once every 4 months for a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

McGill University
University of Toronto
Laval University
Simon Fraser University

Investigators

  • Principal Investigator: Sanjay Kalra, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2021

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00110972

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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