Platform to analyze and understand ALS

Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

This study is trying to gather and analyze a lot of information about ALS and related disorders by having participants, including healthy individuals, come in for check-ups and tests over a year to help improve future research.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alberta (other)
• Locations: 4 sites (Edmonton, Alberta and 3 other locations)
• Trial ID: NCT05204017 on ClinicalTrials.gov

What this trial studies

CAPTURE ALS is a long-term observational platform designed to collect and analyze extensive data on Amyotrophic Lateral Sclerosis (ALS) and related disorders. Participants will undergo up to five in-person visits over a year, where they will receive clinical evaluations, neurocognitive and speech testing, and MRI scans. Healthy controls will also participate for comparison purposes. The collected biospecimens and data will be stored in a biorepository and made available to researchers globally to advance ALS research.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with ALS or related neurodegenerative disorders, as well as healthy controls aged 40-80.

Not a fit: Patients with conditions unrelated to ALS or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this platform could significantly enhance our understanding of ALS and lead to improved treatment strategies.

How similar studies have performed: Other studies utilizing biorepositories and multimodal data collection have shown promise in advancing research in neurodegenerative diseases.

Eligibility criteria

\[PATIENTS\]

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).

Where this trial is running

Edmonton, Alberta and 3 other locations

• University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
• University of Toronto / Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
• McGill University / Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada (RECRUITING)
• CHU de Quebec -Universite de Laval — Québec, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Sanjay Kalra, MD — University of Alberta
• Study coordinator: Claire Magnussen, PhD

Conditions: Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy, Frontotemporal Degeneration, Biomarker, Biorepository, ALS, Disease Progression