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Идёт набор NCT07000851

Imaging Studies in Corticobasal Syndrome

— Наблюдательное Cortico Basal Degeneration Corticobasal Syndrome Corticobasal Syndrome(CBS) Corticobasal Degeneration

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
В протоколе указаны: C-11 ER176 Radiotracer, C-11 PiB, AV1451 Tau.
Кому может быть актуально
Состояния в реестре: Cortico Basal Degeneration, Corticobasal Syndrome, Corticobasal Syndrome(CBS), Corticobasal Degeneration. Базовые параметры: от 18 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
США
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

Neuroinflammation, White Matter Integrity, AD Biomarkers and Pathology in Corticobasal Syndrome

Обзор

The primary goal of this study is to investigate inflammation and white matter damage in corticobasal syndrome and determine whether these processes are related to each other. The investigator's will address our goal by using neuroimaging and blood plasma biomarkers, as well as molecular pathology.

Подробное описание

Corticobasal syndrome (CBS) is a neurodegenerative disorder characterized by cognitive and behavioral change, as well as asymmetric parkinsonism, dystonia, myoclonus, and limb apraxia. Emerging evidence suggests neuroinflammation plays a key role in the pathogenesis of neurodegenerative disease, including the 4R tauopathies and AD, and neuroinflammation has been linked mechanistically to damage of the white matter. The primary goal of this study is to investigate inflammation and white matter damage using imaging and blood samples.

The investigator's will use the PET ligand 11C-ER176 to assess patterns of neuroinflammation in the brain and Neurite Orientation Dispersion and Density Imaging (NODDI) to measure white matter microstructure, including axonal density and alignment. The investigator's will also investigate blood plasma metrics, including neurofilament light chain and plasma glial fibrillary acidic protein (GFAP) that measure neuroaxonal injury and astrogliosis, and inflammation and tau metrics. The investigator's will employ beta-amyloid (A) and tau (T) PET to subdivide the CBS patients into those with biomarker AD (A+T+, CBS-AD) and those without biomarker AD (CBS-4R). The investigator's will also compare these groups to disease controls with typical amnestic biomarker AD (Amn-AD) and healthy controls (HC) that have previously been recruited for other grants (existing data collected under approved IRBs).

Вмешательства

  • Диагностический тест C-11 ER176 Radiotracer
    PET scan looking for inflammation
  • Диагностический тест C-11 PiB
    PET scan looking for amyloid protein
  • Диагностический тест AV1451 Tau
    Pet scan looking for Tau protein

Первичные конечные точки

  • The investigators will use C-11 ER176 PET imaging to evaluate neuroinflammation and white matter integrity in CBS [Срок оценки: approximately 4-5 years into study visits]
Вторичные конечные точки (1)
  • the investigators will use blood samples to assess inflammatory and tau blood plasma metrics in CBS. [Срок оценки: approximately 4-5 years into study visits]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Meet possible or probable CBS criteria

Критерии исключения

  • Subjects will be excluded if MRI is contraindicated (due to implanted device, severe claustrophobia, etc)
  • Subjects will be excluded if they have a concurrent illnesses or structural abnormality that could account for the CBS syndrome
  • Subjects will be excluded if they have a mutation in the progranulin gene
  • Subjects will excluded if they have received anti-Aβ therapy
  • Women who are pregnant will be excluded
  • Subjects will be excluded if they are actively taking daily anti-inflammatory medications (NSAIDs, corticosteriods, etc)
  • Subjects will be excluded if they have generalized inflammatory condition and treatment with immunosuppressive, corticoid/glucocorticoid, steroidal or non-steroidal anti-inflammatory medication within 2 weeks of scanning

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

США · 1 центр
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT07000851 · 24-007544 · 1R01AG087140-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗