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

  • STATUS
    Recruiting
  • End date
    Aug 27, 2023
  • participants needed
    150
  • sponsor
    University of Alberta
Updated on 27 April 2022
Accepts healthy volunteers

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.

Details
Condition Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy, Frontotemporal Degeneration
Clinical Study IdentifierNCT05204017
SponsorUniversity of Alberta
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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)
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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