Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

Amyotrophic Lateral Sclerosis Clinical Trial

— CAPTURE ALS  

Official title:

Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204017
• Other study ID #: Pro00110972
• Status: Recruiting
• Start date: September 12, 2021
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: University of Alberta
• Contact: Claire Magnussen, PhD
• Phone: 514-398-6188
• Email: info[@]captureals.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

[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).

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Frontotemporal Degeneration
• Motor Neuron Disease
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Primary Lateral Sclerosis
• Progressive Muscular Atrophy
• Sclerosis

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	McGill University / Montreal Neurological Institute and Hospital	Montreal	Quebec
Canada	CHU de Quebec -Universite de Laval	Québec	Quebec
Canada	University of Toronto / Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
University of Alberta	Laval University, McGill University, Simon Fraser University, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALS Functional Rating Scale-Revised (ALSFRS-R)	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.	Once every 4 months for a year
Primary	Forced Vital Capacity (FVC)	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.	Once every 4 months for a year
Primary	Speech Testing	Changes in speech function over time will be measured using a web-browser based audio and video data collection tool.	Once every 4 months for a year
Primary	Neurological dysfunction as detected during standard neurological examination	Changes in neurological function over time will be measured through a standard neurological examination.	Once every 4 months for a year
Primary	Magnetic Resonance Imaging (MRI)	Various advanced MRI techniques will be used to assess nervous system structure and function.	Once every 4 months for a year
Primary	Edinburgh Cognitive and Behavioural Screen (ECAS)	Changes in cognitive function over time will be measured by the ECAS.	Once every 4 months for a year
Primary	ALS Assessment Questionnaire (ALSAQ-5)	Changes in quality of life over time will be measured using the ALSAQ-5, a participant reported outcome measure.	Once every 4 months for a year
Primary	World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF)	Changes in quality of life over time will be measured using the WHO-QOL-BREF, a participant reported outcome measure.	Once every 4 months for a year