Lombard Cohort of Brain Health Services
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Subjective Cognitive Decline (SCD), Functional Cognitive Disorder, Alzheimer's Disease, Brain Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline [Time frame: Baseline (first visit at Brain Health Service)]
Secondary outcome measures (3)
- Psychological impact of biomarker disclosure at1 week [Time frame: Baseline (pre-disclosure) and 1 week after biomarker disclosure]
- Predictors of AD plasma biomarker positivity at baseline [Time frame: Baseline]
- Predictors of longitudinal changes in AD biomarkers [Time frame: Baseline through 5 years follow-up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Diagnosis of mild cognitive impairment or dementia at baseline visit
- Enrollment in another interventional study with an expected effect on cognition
- Pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 5 centers
- Villa Beretta Rehabilitation Center — Costa Masnaga
- IRCCS Auxologico — Milan
- IRCCS Don Gnocchi — Milan
- Fondazione IRCCS San Gerardo dei Tintori — Monza
- IRCCS Policlinico San Donato — San Donato Milanese
Identifiers
NCT: NCT07457138 · LoBHeS