Lombard Cohort of Brain Health Services
Recruiting · NCT07457138 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Milano Bicocca
View the official record on ClinicalTrials.gov →What this trial is about
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 can take part
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
Where it is running
5 locations listed.
- 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