Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

NCT05204017 | Recruiting

• 1 other identifier: Pro00110972
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Frontotemporal Degeneration; Progressive Muscular Atrophy

Keywords

Biomarker; Biorepository; ALS; Disease Progression; MRI; Biofluids

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Once every 4 months for a year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• N/A
• \[HEALTHY CONTROLS\]
• 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
• 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).

Sponsors & Collaborators

• University of Alberta: lead
• McGill University: collaborator
• Laval University: collaborator
• University of Toronto: collaborator
• Simon Fraser University: collaborator

Study Sites (4)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

University of Toronto / Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

McGill University / Montreal Neurological Institute and Hospital

Montreal, Quebec, H4A2H6, Canada

RECRUITING

CHU de Quebec -Universite de Laval

Québec, Quebec, G1J 1Z, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41343582 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, DNA, RNA, Cerebrospinal Fluid, Induced Pluripotent Stem Cells, Saliva

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Muscular Atrophy, Spinal; Disease Progression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjay Kalra, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Magnussen, PhD

CONTACT

514-398-6188; info@captureals.ca

Sara Moradipoor

CONTACT

780-248-1805; moradipo@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 24, 2022
• Study Start: September 12, 2021
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CA (4)