Lombard Cohort of Brain Health Services

Sponsor
University of Milano Bicocca
Study ID
NCT07457138
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Mar 9, 2026
Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2033

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Brain Health Service users
    Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment

Primary Outcome Measure

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

Central Contacts

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