Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Health Service users | Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline | Identification of multivariate patterns (e.g., principal component analysis and clustering methods) differentiating individuals positive versus negative for Alzheimer's disease plasma biomarker (p-tau217) at baseline, based on demographic, clinical, neuropsychological, radiological, and biological variables. | Baseline (first visit at Brain Health Service) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological impact of biomarker disclosure at1 week | Change in psychological measures (Hospital Anxiety and Depression Scale - HADS; Impact of Event Scale - Revised - IES-R) before and one week after communication of biomarker results. | Baseline (pre-disclosure) and 1 week after biomarker disclosure |
| Predictors of AD plasma biomarker positivity at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of conversion to MCI or dementia | Evaluation of clinical, biological (plasma and CSF biomarkers), radiological, and neuropsychological predictors of progression to mild cognitive impairment (MCI) or dementia using survival analysis (Kaplan-Meier and Cox models). | Baseline through 5 years follow-up |
| Predictive performance of plasma biomarkers for AD diagnosis |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects accessing BHS in Lombardy with SCD, FCD or "well worried" individuals without objective cognitive impairment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Emanuele Pozzi, MD | Contact | +393494113421 | federicoemanuele.pozzi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Ferrarese, MD, PhD | University of Milano Bicocca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Villa Beretta Rehabilitation Center | Recruiting | Costa Masnaga | Lombardy | Italy |
De-identified individual participant data underlying the results reported in publications (including demographic, clinical, neuropsychological, biomarker, and imaging-derived variables) will be made available.
Beginning 12 months after primary publication and ending 5 years thereafter.
Data will be available to researchers who provide a methodologically sound proposal, subject to approval by the study steering committee and signing of a data use agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Plasma, blood, cerebrospinal fluid
Identification of demographic, clinical, neuropsychological, and radiological predictors of baseline AD plasma biomarker positivity, assessed using logistic and regression models. |
| Baseline |
| Predictors of longitudinal changes in AD biomarkers | Identification of clinical, neuropsychological, and radiological predictors of longitudinal changes in plasma AD biomarkers over time using linear mixed-effects models. | Baseline through 5 years follow-up |
Assessment of diagnostic accuracy of plasma biomarkers (neurodegeneration, Alzheimer's pathology, neuroinflammation markers) in predicting CSF biomarker positivity for AD using logistic regression models and ROC curve analysis. |
| Baseline |
| IRCCS Auxologico | Not yet recruiting | Milan | Lombardy | Italy |
| IRCCS Don Gnocchi | Not yet recruiting | Milan | Lombardy | Italy |
| Fondazione IRCCS San Gerardo dei Tintori | Recruiting | Monza | Lombardy | 20900 | Italy |
|
| IRCCS Policlinico San Donato | Recruiting | San Donato Milanese | Lombardy | 20097 | Italy |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |