Recruiting

Observational Study

Sponsor:

University of Alberta

Code:

NCT05204017

Conditions

Amyotrophic Lateral Sclerosis

Primary Lateral Sclerosis

Progressive Muscular Atrophy

Frontotemporal Degeneration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Progressive Muscular Atrophy

Frontotemporal Degeneration

Study ID

NCT05204017

Start date

Sep 12, 2021

Status verified date

Apr, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

\[PATIENTS\]

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • ALS Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: Once every 4 months for a year ]
  • Forced Vital Capacity (FVC) [ Time Frame: Once every 4 months for a year ]
  • Speech Testing [ Time Frame: Once every 4 months for a year ]
  • Neurological dysfunction as detected during standard neurological examination [ Time Frame: Once every 4 months for a year ]
  • Magnetic Resonance Imaging (MRI) [ Time Frame: Once every 4 months for a year ]
  • Edinburgh Cognitive and Behavioural Screen (ECAS) [ Time Frame: Once every 4 months for a year ]
  • ALS Assessment Questionnaire (ALSAQ-5) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

University of Toronto / Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

McGill University / Montreal Neurological Institute and Hospital

Recruiting

Montreal, Quebec, Canada, H4A2H6

CHU de Quebec -Universite de Laval

Recruiting

Québec, Quebec, Canada, G1J 1Z

More Information

Sponsor

University of Alberta

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Biomarker
  • Biorepository
  • ALS
  • Disease Progression
  • MRI
  • Biofluids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-04-13.