Идёт набор NCT07142954

Epidemiology and Biomarker Study in Alzheimer's Disease

Фаза III С лечением Alzheimer Disease

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: P-tau217 Test.
Кому может быть актуально: Состояния в реестре: Alzheimer Disease. Базовые параметры: 55 лет — 75 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, Япония
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

A Longitudinal, Prospective Epidemiology Study in Alzheimer's Disease: Assessing Neurocognitive and Biomarker Changes and Health Outcomes in Individuals at Risk for Symptoms of Alzheimer's Disease (ANCHOR-AD)

Обзор

Study AACU determines rates of cognitive worsening in participants within elevated and not elevated plasma P-tau217 cohorts. Participation in AACU will last approximately 7 years.

Подробное описание

Study AACU is a non-drug interventional study. The intervention is annual plasma P-tau217 testing. Enrollment is anticipated to be approximately 3400 participants.

Вмешательства

Другое P-tau217 Test
A plasma test measuring phosphorylated tau at Position 217 (P-tau217).

Первичные конечные точки

Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components [Срок оценки: Baseline up to 7 years]

Вторичные конечные точки (12)

Time to Cognitive Worsening Between Groups (Participants Within Elevated and Not-Elevated Plasma P-Tau217) as Measured by Cognitive Composite or Any of the Individual Composite Components [Срок оценки: Baseline up to 7 years]
Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI) [Срок оценки: Baseline up to 7 years]
Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO) [Срок оценки: Baseline up to 7 years]
Time to Cognitive Worsening Between Groups as Measured by CFI [Срок оценки: Baseline up to 7 years]
Time to Cognitive Worsening Between Groups as Measured by XpressO [Срок оценки: Baseline up to 7 years]
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score [Срок оценки: Baseline, Year 7]
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT [Срок оценки: Baseline, Year 7]
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm [Срок оценки: Baseline, Year 7]
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score [Срок оценки: Baseline, Year 7]
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT [Срок оценки: Baseline, Year 7]
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm [Срок оценки: Baseline, Year 7]
Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline [Срок оценки: Baseline]

Критерии участия

Критерии включения

The participant must self-report unimpaired cognition.
The participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening.

Критерии исключения

Have seen a doctor about memory concerns.
Have a history or diagnosis of cognitive impairment, or significant other neurodegenerative disease that can affect cognition.
Are currently enrolled or have previously participated in any Alzheimer's Disease (AD)-related study involving an investigational drug intervention.
Are currently using or have previously used prescription medications for treatment of mild cognitive impairment (MCI) or dementia such as amyloid targeting therapy (that is, lecanemab, donanemab, aducanumab), cholinesterase inhibitors (for example, benzgalantamine, donepezil, galantamine, rivastigmine), and memantine.

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

Здоровые добровольцы: Да