Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS (CAPTURE ALS)

• ClinicalTrials.gov Identifier: NCT05204017
• Recruitment Status: Recruiting
• First Posted: January 24, 2022
• Last Update Posted: February 13, 2023
• Sponsor: University of Alberta
• Collaborators: McGill University; Laval University; University of Toronto; Simon Fraser University
• Information provided by (Responsible Party): University of Alberta

Study Description

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.

Condition or disease
Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Progressive Muscular Atrophy; Frontotemporal Degeneration

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 150 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS
• Actual Study Start Date: September 12, 2021
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: August 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. ALS Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: 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.
2. Forced Vital Capacity (FVC) [ Time Frame: 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.
3. Speech Testing [ Time Frame: 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.
4. Neurological dysfunction as detected during standard neurological examination [ Time Frame: Once every 4 months for a year ]
   Changes in neurological function over time will be measured through a standard neurological examination.
5. Magnetic Resonance Imaging (MRI) [ Time Frame: Once every 4 months for a year ]
   Various advanced MRI techniques will be used to assess nervous system structure and function.
6. Edinburgh Cognitive and Behavioural Screen (ECAS) [ Time Frame: Once every 4 months for a year ]
   Changes in cognitive function over time will be measured by the ECAS.
7. ALS Assessment Questionnaire (ALSAQ-5) [ Time Frame: 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.
8. World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF) [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

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).

Contacts and Locations

Contacts

Contact: Claire Magnussen, PhD; 514-398-6188; info@captureals.ca

Contact: Sara Moradipoor; 780-248-1805; moradipo@ualberta.ca

Locations

Canada, Alberta

University of Alberta; Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Canada, Ontario

University of Toronto / Sunnybrook Health Sciences Centre; Recruiting

Toronto, Ontario, Canada, M4N 3M5

Canada, Quebec

McGill University / Montreal Neurological Institute and Hospital; Recruiting

Montreal, Quebec, Canada, H4A2H6

CHU de Quebec -Universite de Laval; Recruiting

Québec, Quebec, Canada, G1J 1Z

Sponsors and Collaborators

University of Alberta

McGill University

Laval University

University of Toronto

Simon Fraser University

Investigators

• Principal Investigator: Sanjay Kalra, MD; University of Alberta

More Information

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT05204017
• Other Study ID Numbers: Pro00110972
• First Posted: January 24, 2022
• Last Update Posted: February 13, 2023
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:

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

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Muscular Atrophy; Muscular Atrophy, Spinal; Sclerosis; Pathologic Processes; Atrophy; Pathological Conditions, Anatomical; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations