Actively Recruiting

Age: 18Years +
All Genders
NCT07457138

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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