Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

Overview

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.

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.

Primary outcome measures

• 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]

Eligibility criteria

\[PATIENTS\]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Canada · 4 centers

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

Publications

• 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, Vel PMID 41343582

Identifiers

NCT: NCT05204017 · Pro00110972

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗