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Идёт набор NCT03402919

Comprehensive Assessment of Neurodegeneration and Dementia

— Наблюдательное Dementia Mild Cognitive Impairment (MCI) Subjective Cognitive Impairment Parkinson's Disease (PD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Impairment, Parkinson's Disease (PD). Базовые параметры: 50 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Comprehensive Assessment of Neurodegeneration and Dementia Study

Обзор

This is a longitudinal observational study recruiting individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group without cognitive deficits. Participants are/will be recruited at sites across Canada and will undergo assessments, neuroimaging, and biological sample collection.

Подробное описание

This is a longitudinal observational study that started in Phase I with the recruitment of 1173 participants between the ages of 50 and 90 years with Subjective Cognitive Impairment, Mild Cognitive Impairment, Mild Cognitive Impairment with subcortical vascular lesions, Alzheimer's Disease, Mixed dementia, Lewy Body Dementia, Parkinson's Disease Dementia, Parkinson's Disease with Mild Cognitive Impairment and Frontotemporal Dementia as well as healthy elderly subjects without cognitive complaints or deficits. These participants were enrolled in 30 different centres across Canada.

All subjects involved in the study underwent rigorous evaluations at baseline, including clinical assessment, neuropsychological assessment, genomics and neuroimaging. Biological samples from blood, saliva, urine, fecal matter, buccal cells and cerebrospinal fluid were collected, stored, and analyzed.

Longitudinal follow-up determining if there has been any change in their diagnosis was carried out annually and longitudinal re-evaluation was carried out at two times: Time 2 and Time 3.

In Time 3, 400 participants across the non-dementia cohorts (Cognitively Unimpaired, Subjective Cognitive Impairment, Mild Cognitive Impairment, Mild Cognitive Impairment with a Vascular Component, Parkinson's Disease with no Cognitive Impairment, Parkinson's Disease with Mild Cognitive Impairment) with up to 12 years of education will be recruited.

Первичные конечные точки

  • Montreal Cognitive Assessment (MoCA) score [Срок оценки: 8 years]

Критерии участия

Критерии включения

  • Has subjective or objective cognitive impairment
  • Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from a caregiver/family member)
  • Sufficient proficiency in English or French to undertake self report and neuropsychological testing
  • Geographic accessibility to the study site
  • Must have a study partner who can participate as required in the protocol (provide corroborative information)
  • Up to 12 years of education
  • Fits into one of the following groups: Cognitively Unimpaired, Subjective Cognitive Impairment, Mild Cognitive Impairment, Vascular Mild Cognitive Impairment, Parkinson's Disease, Parkinson's Disease with Mild Cognitive Impairment

Критерии исключения

  • The presence of other significant known chronic brain disease such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, malignant tumors, Parkinson's disease (other than for the Parkinson's cohort), and other rarer brain illnesses
  • Ongoing alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures
  • Symptomatic stroke within the previous year
  • Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 19 центров
  • University of Calgary — Calgary
  • University of Alberta Hospital — Edmonton
  • Djavad Mowafaghian Centre for Brain Health — Vancouver
  • Island Health — Victoria
  • Veteran's Memorial Building — Halifax
  • Hamilton General Hospital — Hamilton
  • St. Joseph's Health Care London — London
  • Gait and Brain Lab — London
  • … и ещё 11 центров

Публикации

  • Montero-Odasso M, Sarquis-Adamson Y, Kamkar N, Pieruccini-Faria F, Bray N, Cullen S, Mahon J, Titus J, Camicioli R, Borrie MJ, Bherer L, Speechley M. Dual-task gait speed assessments with an electronic walkway and a stopwatch in older adults. A reliability study. Exp Gerontol. 2020 Dec;142:111102. doi: 10.1016/j.exger.2020.111102. Epub 2020 Oct 2. PMID 33017671

Идентификаторы

NCT: NCT03402919 · CCNA 2015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗