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RECRUITINGOBSERVATIONAL

Lombard Cohort of Brain Health Services

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - Diagnosis of mild cognitive impairment or dementia at baseline visit - Enrollment in another interventional study with an expected effect on cognition - Pregnancy or breastfeeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of mild cognitive impairment or dementia at baseline visit * Enrollment in another interventional study with an expected effect on cognition * Pregnancy or breastfeeding

Locations (5)

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