Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05204017

Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Disease Attributes Disease Progression Frontotemporal Degeneration Metabolic Diseases Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Lateral Sclerosis Progressive Muscular Atrophy Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

[PATIENTS]

Inclusion criteria

  • 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

Exclusion criteria

N/A

[HEALTHY CONTROLS]

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Magnussen, PhD

CONTACT

[email protected]

514-398-6188

Sara Moradipoor

CONTACT

[email protected]

780-248-1805

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Laval University
  • McGill University
  • Simon Fraser University
  • University of Toronto

Registry information

Acronym: CAPTURE ALS

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Jan 24, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.