RecruitingNCT07457138

Lombard Cohort of Brain Health Services


Sponsor

University of Milano Bicocca

Enrollment

1,000 participants

Start Date

Feb 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows adults in the Lombardy region of Italy who are concerned about their memory or thinking skills but have not yet been diagnosed with dementia or significant cognitive decline. Researchers want to understand who is at risk of developing cognitive problems and how early interventions through Brain Health Services might help. **You may be eligible if...** - You are 18 years or older - You have been seen at a Brain Health Service in Lombardy and have either subjective cognitive decline (you notice memory changes but tests are normal), functional cognitive disorder (memory concerns linked to anxiety or stress), or you are a "well worried" individual without any objective cognitive impairment - You can provide written informed consent **You may NOT be eligible if...** - You already have mild cognitive impairment or dementia at your first visit - You are enrolled in another study that affects cognition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT07457138


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