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Lombard Cohort of Brain Health Services

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Villa Beretta Rehabilitation Center
RECRUITING
Costa Masnaga
IRCCS Auxologico
NOT_YET_RECRUITING
Milan
IRCCS Don Gnocchi
NOT_YET_RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Contact Information
Primary
Federico Emanuele Pozzi, MD
federicoemanuele.pozzi@gmail.com
+393494113421
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2033-02-01
Participants
Target number of participants: 1000
Treatments
Brain Health Service users
Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment
Related Therapeutic Areas
Sponsors
Leads: University of Milano Bicocca

This content was sourced from clinicaltrials.gov