Amyotrophic Lateral Sclerosis, Frontotemporal Degeneration, Primary Lateral Sclerosis, Progressive Muscular Atrophy
Conditions
Keywords
Biomarker, Biorepository, ALS, Disease Progression, MRI, Biofluids
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.
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.
Interventions
None listed
Sponsors
University of Alberta
McGill University
Laval University
University of Toronto
Simon Fraser University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALS Functional Rating Scale-Revised (ALSFRS-R) | 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. |
| Forced Vital Capacity (FVC) | 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. |
| Speech Testing | 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. |
| Neurological dysfunction as detected during standard neurological examination | Once every 4 months for a year | Changes in neurological function over time will be measured through a standard neurological examination. |
| Magnetic Resonance Imaging (MRI) | Once every 4 months for a year | Various advanced MRI techniques will be used to assess nervous system structure and function. |
| Edinburgh Cognitive and Behavioural Screen (ECAS) | Once every 4 months for a year | Changes in cognitive function over time will be measured by the ECAS. |
| ALS Assessment Questionnaire (ALSAQ-5) | 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. |
| World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF) | 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. |
Countries
Canada
Contacts
CONTACTClaire Magnussen, PhD
CONTACTSara Moradipoor
PRINCIPAL_INVESTIGATORSanjay Kalra, MD
University of Alberta
Outcome results
None listed