Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS (CAPTURE ALS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05204017|
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : February 13, 2023
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|Condition or disease|
|Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Progressive Muscular Atrophy Frontotemporal Degeneration|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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|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|
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
Healthy controls that are age and sex matched to patients
- 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
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05204017
|Contact: Claire Magnussen, PhDemail@example.com|
|Contact: Sara Moradipoorfirstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|University of Toronto / Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|McGill University / Montreal Neurological Institute and Hospital||Recruiting|
|Montreal, Quebec, Canada, H4A2H6|
|CHU de Quebec -Universite de Laval||Recruiting|
|Québec, Quebec, Canada, G1J 1Z|
|Principal Investigator:||Sanjay Kalra, MD||University of Alberta|
|Responsible Party:||University of Alberta|
|Other Study ID Numbers:||
|First Posted:||January 24, 2022 Key Record Dates|
|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|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Atrophy, Spinal
Pathological Conditions, Anatomical
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases