MedTrace Logo

Lombard Cohort of Brain Health Services

NCT07457138 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-03-17

No results posted yet for this 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.

Conditions

  • Subjective Cognitive Decline (SCD)
  • Functional Cognitive Disorder
  • Alzheimer's Disease
  • Brain Health

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Carlo Ferrarese, MD, PhD · University of Milano Bicocca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-01
Completion
2033-02-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457138 on ClinicalTrials.gov