Lombard Cohort of Brain Health Services

Обзор

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.

Первичные конечные точки

• Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline [Срок оценки: Baseline (first visit at Brain Health Service)]

Вторичные конечные точки (3)

• Psychological impact of biomarker disclosure at1 week [Срок оценки: Baseline (pre-disclosure) and 1 week after biomarker disclosure]
• Predictors of AD plasma biomarker positivity at baseline [Срок оценки: Baseline]
• Predictors of longitudinal changes in AD biomarkers [Срок оценки: Baseline through 5 years follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Diagnosis of mild cognitive impairment or dementia at baseline visit
• Enrollment in another interventional study with an expected effect on cognition
• Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 5 центров

• Villa Beretta Rehabilitation Center — Costa Masnaga
• IRCCS Auxologico — Milan
• IRCCS Don Gnocchi — Milan
• Fondazione IRCCS San Gerardo dei Tintori — Monza
• IRCCS Policlinico San Donato — San Donato Milanese

Идентификаторы

NCT: NCT07457138 · LoBHeS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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