Lombard Cohort of Brain Health Services (LoBHeS)

March 13, 2026 updated by: University of Milano Bicocca

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardy
      • Costa Masnaga, Lombardy, Italy
        • Recruiting
        • Villa Beretta Rehabilitation Center
        • Principal Investigator:
          • Franco Molteni, MD
        • Contact:
      • Milan, Lombardy, Italy
        • Not yet recruiting
        • IRCCS Auxologico
      • Milan, Lombardy, Italy
        • Not yet recruiting
        • IRCCS Don Gnocchi
      • Monza, Lombardy, Italy, 20900
      • San Donato Milanese, Lombardy, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
        • Principal Investigator:
          • Federico Emanuele Pozzi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects accessing BHS in Lombardy with SCD, FCD or "well worried" individuals without objective cognitive impairment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Brain Health Service users
Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline
Time Frame: 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.
Baseline (first visit at Brain Health Service)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological impact of biomarker disclosure at1 week
Time Frame: 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.
Baseline (pre-disclosure) and 1 week after biomarker disclosure
Predictors of longitudinal changes in AD biomarkers
Time Frame: 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.
Baseline through 5 years follow-up
Predictors of AD plasma biomarker positivity at baseline
Time Frame: Baseline
Identification of demographic, clinical, neuropsychological, and radiological predictors of baseline AD plasma biomarker positivity, assessed using logistic and regression models.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of conversion to MCI or dementia
Time Frame: Baseline through 5 years follow-up
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Investigators

  • Study Chair: Carlo Ferrarese, MD, PhD, University of Milano Bicocca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2033

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LoBHeS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in publications (including demographic, clinical, neuropsychological, biomarker, and imaging-derived variables) will be made available.

IPD Sharing Time Frame

Beginning 12 months after primary publication and ending 5 years thereafter.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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