Biomarker-based Alzheimer's Disease Cohort Study (BASIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,835
- 试验地点
- 1
- 主要终点
- The event of conversion from mild cognitive impairment to dementia within three years.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(1) Individuals who are unable to complete the assessment due to severe psychological or physiological disorders.
结局指标
主要结局
The event of conversion from mild cognitive impairment to dementia within three years.
时间窗: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
The event of conversion from mild cognitive impairment to dementia within three years. Cognitive status will be assessed using Clinical Dementia Rating scale-Global Score (CDR-GS): mild cognitive impairment: CDR-GS = 0.5; dementia: CDR-GS \> 0.5.
次要结局
- Hachinski Ischemia Score(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Memory - Immediate Recall(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Digit Span Test(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Trail Making Test (TMT)(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Boston Naming Test(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Memory - Delayed Recall(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Memory - Cued Recall(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Subjective Cooperation Score(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Neuropsychiatric Inventory (NPI)(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Geriatric Depression Scale (GDS)(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Daily and Overall Functional Assessment(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Activities of Daily Living (ADL)(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Clinical events(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Blood biomarkers(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Magnetic resonance imaging (MRI) examination(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Electroencephalogram (EEG)(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Polysomnography(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Positron Emission Tomography (PET) scan(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Cerebrospinal fluid (CSF) examination(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)
- Near-infrared brain functional imaging(Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.)