Lombard Cohort of Brain Health Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline
研究概览
简要总结
The goal of this multicenter prospective observational cohort study is to better understand the clinical, neuropsychological, and biological characteristics of individuals attending Brain Health Services (BHS) in the Lombardy region. The study focuses on adults with subjective cognitive decline (SCD), functional cognitive disorder (FCD), or "well worried" individuals without objective cognitive impairment.
The main questions it aims to answer are:
- What clinical, cognitive, and biological differences exist between individuals who are positive versus negative for Alzheimer's disease (AD) plasma biomarkers (p-tau217) at baseline?
- What factors predict positivity to AD biomarkers at baseline?
- How does communication of biomarker results (risk disclosure) affect psychological well-being shortly after receiving results?
- What factors predict longitudinal changes in AD biomarkers over 5 years?
- Do baseline biomarkers predict the development of mild cognitive impairment (MCI) or dementia during follow-up?
Participants will:
- Undergo standard clinical evaluation at their local BHS
- Provide blood samples for plasma biomarker analysis (e.g., p-tau217, GFAP, NfL, ApoE)
- Undergo neuropsychological testing and cognitive screening
- Complete questionnaires assessing psychological impact and risk perception (before and after biomarker disclosure)
- Undergo additional center-specific procedures when clinically indicated (e.g., MRI, lumbar puncture, polysomnography)
- Be followed annually for 5 years
The study plans to enroll approximately 1000 participants across multiple BHS in Lombardy and will follow them for a total duration of 7 years. The results will help clarify the role of biomarkers in early cognitive complaints and support the development of preventive strategies within BHS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Diagnosis of SCD, FCD, or "well worried" individuals without objective cognitive impairment
- •Evaluation at one of the Lombardy BHS
- •Ability to provide written informed consent
排除标准
- •Diagnosis of mild cognitive impairment or dementia at baseline visit
- •Enrollment in another interventional study with an expected effect on cognition
- •Pregnancy or breastfeeding
研究组 & 干预措施
Brain Health Service users
Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment
结局指标
主要结局
Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline
时间窗: Baseline (first visit at Brain Health Service)
Identification of multivariate patterns (e.g., principal component analysis and clustering methods) differentiating individuals positive versus negative for Alzheimer's disease plasma biomarker (p-tau217) at baseline, based on demographic, clinical, neuropsychological, radiological, and biological variables.
次要结局
- Psychological impact of biomarker disclosure at1 week(Baseline (pre-disclosure) and 1 week after biomarker disclosure)
- Predictors of longitudinal changes in AD biomarkers(Baseline through 5 years follow-up)
- Predictors of AD plasma biomarker positivity at baseline(Baseline)