Alzheimer's Disease, Brain Health, Functional Cognitive Disorder, Subjective Cognitive Decline (SCD)
Conditions
Keywords
Brain Health Services, Subjective Cognitive Decline, Alzheimer's Disease, Functional Cognitive Disorder, pTau-217, GFAP, NfL
Brief 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.
Interventions
None listed
Sponsors
University of Milano Bicocca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline | Baseline (first visit at Brain Health Service) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological impact of biomarker disclosure at1 week | Baseline (pre-disclosure) and 1 week after biomarker disclosure | 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. |
| Predictors of AD plasma biomarker positivity at baseline | Baseline | Identification of demographic, clinical, neuropsychological, and radiological predictors of baseline AD plasma biomarker positivity, assessed using logistic and regression models. |
| Predictors of longitudinal changes in AD biomarkers | Baseline through 5 years follow-up | Identification of clinical, neuropsychological, and radiological predictors of longitudinal changes in plasma AD biomarkers over time using linear mixed-effects models. |
Countries
Italy
Contacts
CONTACTFederico Emanuele Pozzi, MD
STUDY_CHAIRCarlo Ferrarese, MD, PhD
University of Milano Bicocca
Outcome results
None listed