Идёт набор NCT07109999

Biomarker-based Alzheimer's Disease Cohort Study (BASIC)

— Наблюдательное 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: None-placebo.
Кому может быть актуально: Состояния в реестре: Alzheimer Disease. Базовые параметры: от 40 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study adopts a prospective cohort design, constructing a single-center cohort by recruiting patients with Alzheimer's disease (AD) who are positive for AD biomarkers. First, the investigators aim to establish a cohort of AD patients with positive biomarkers, thereby reserving suitable patient resources for future AD-related clinical trials. Second, based on the established cohort, the investigators will explore the associations between AD-related biomarkers and clinical manifestations among the elderly population in China, and identify potential risk factors influencing the progression of AD. Third, according to the identified risk factors for AD progression, the investigators will construct a risk early warning model for the progression rate of AD based on biomarkers, in order to achieve early identification and precise prevention and control of the progression risk of AD.

Вмешательства

Другое None-placebo
This study is an observational study, and no interventions will be implemented.

Первичные конечные точки

The event of conversion from mild cognitive impairment to dementia within three years. [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]

Вторичные конечные точки (12)

Hachinski Ischemia Score [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Memory - Immediate Recall [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Digit Span Test [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Trail Making Test (TMT) [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Boston Naming Test [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Memory - Delayed Recall [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Memory - Cued Recall [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Subjective Cooperation Score [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Neuropsychiatric Inventory (NPI) [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Geriatric Depression Scale (GDS) [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Daily and Overall Functional Assessment [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Activities of Daily Living (ADL) [Срок оценки: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]

Критерии участия

Критерии включения

(1) Patients aged 40 years or older;
(2) Visiting Xuanwu Hospital, Capital Medical University;
(3) Meeting the core clinical diagnostic criteria for Alzheimer's disease (AD) - related mild cognitive impairment or probable AD according to the NIA-AA (2011);
(4) Amyloid positivity confirmed by amyloid PET or cerebrospinal fluid biomarker tests;
(5) Providing informed consent.