Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• ALS Functional Rating Scale-Revised (ALSFRS-R) [Срок оценки: Once every 4 months for a year]
• Forced Vital Capacity (FVC) [Срок оценки: Once every 4 months for a year]
• Speech Testing [Срок оценки: Once every 4 months for a year]
• Neurological dysfunction as detected during standard neurological examination [Срок оценки: Once every 4 months for a year]
• Magnetic Resonance Imaging (MRI) [Срок оценки: Once every 4 months for a year]
• Edinburgh Cognitive and Behavioural Screen (ECAS) [Срок оценки: Once every 4 months for a year]
• ALS Assessment Questionnaire (ALSAQ-5) [Срок оценки: Once every 4 months for a year]
• World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF) [Срок оценки: Once every 4 months for a year]

Критерии участия

\[PATIENTS\]

Критерии включения

• 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

Критерии исключения

N/A

\[HEALTHY CONTROLS\]

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Канада · 4 центра

• University of Alberta — Edmonton
• University of Toronto / Sunnybrook Health Sciences Centre — Toronto
• McGill University / Montreal Neurological Institute and Hospital — Montreal
• CHU de Quebec -Universite de Laval — Québec

Публикации

• Saunders N, Magnussen C, Kang H, Blais M, Bhinder H, Pfeffer G, Genuis SK, Bouvier L, Anand T, Abou-Haidar R, Abrahao A, Boivin MN, Bowser R, Bubela T, Chiappini J, Das S, Dhanoa A, Dupre N, Evans A, Ferry N, Frater Y, Genge A, Graham SJ, Greiner R, Medina YI, Johnston WS, Jones KE, Karamchandani J, Kriz J, Luth W, Matte G, Rogaeva E, Robertson J, Seres P, Tam F, Taylor D, Tremblay-Desbiens C, Vel PMID 41343582

Идентификаторы

NCT: NCT05204017 · Pro00110972

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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