Actively Recruiting
Lombard Cohort of Brain Health Services
Led by University of Milano Bicocca · Updated on 2026-03-17
1000
Participants Needed
5
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Lombard Cohort of Brain Health Services
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosis of subjective cognitive decline, functional cognitive disorder, or "well worried" individuals without objective cognitive impairment
- Evaluation at one of the Lombardy Brain Health Services
- Ability to provide written informed consent
You will not qualify if you...
- Diagnosis of mild cognitive impairment or dementia at baseline visit
- Enrollment in another interventional study affecting cognition
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Villa Beretta Rehabilitation Center
Costa Masnaga, Lombardy, Italy
Actively Recruiting
2
IRCCS Auxologico
Milan, Lombardy, Italy
Not Yet Recruiting
3
IRCCS Don Gnocchi
Milan, Lombardy, Italy
Not Yet Recruiting
4
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy, 20900
Actively Recruiting
5
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, Italy, 20097
Actively Recruiting
Research Team
F
Federico Emanuele Pozzi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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