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Clinical Trials in Italy / NCT07457138
Recruiting Observational

Lombard Cohort of Brain Health Services

NCT07457138 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milano Bicocca
Phase
Observational
Started
2026-02-01
Last updated
2026-03-17

Condition(s) studied

Subjective Cognitive Decline (SCD)Functional Cognitive DisorderAlzheimer's DiseaseBrain Health

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (5)

FacilityCityRegionStatus
Villa Beretta Rehabilitation Center Costa Masnaga Lombardy Recruiting
IRCCS Auxologico Milan Lombardy Not Yet Recruiting
IRCCS Don Gnocchi Milan Lombardy Not Yet Recruiting
Fondazione IRCCS San Gerardo dei Tintori Monza Lombardy Recruiting
IRCCS Policlinico San Donato San Donato Milanese Lombardy Recruiting

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Other trials for the same condition

InRAD Observational Study Recruiting
Digital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors Recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease Recruiting
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD) Active, not recruiting
The Signature of Alzheimer's Disease in Subjective Cognitive Decline Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07457138 on ClinicalTrials.gov ↗ ← All trials in Italy