Lombard Cohort of Brain Health Services

NCT07457138 | Recruiting

• 1 other identifier: LoBHeS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Brain Health Services; Subjective Cognitive Decline; Alzheimer's Disease; Functional Cognitive Disorder; pTau-217; GFAP; NfL

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Psychological impact of biomarker disclosure at1 week

  Baseline (pre-disclosure) and 1 week after biomarker disclosure

• Predictors of AD plasma biomarker positivity at baseline

  Baseline

• Predictors of longitudinal changes in AD biomarkers

  Baseline through 5 years follow-up

Other Outcomes (2)

• Predictors of conversion to MCI or dementia

  Baseline through 5 years follow-up

• Predictive performance of plasma biomarkers for AD diagnosis

  Baseline

Study Arms (1)

Brain Health Service users

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of mild cognitive impairment or dementia at baseline visit
• Enrollment in another interventional study with an expected effect on cognition
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (5)

Villa Beretta Rehabilitation Center

Costa Masnaga, Lombardy, Italy

RECRUITING

IRCCS Auxologico

Milan, Lombardy, Italy

NOT YET RECRUITING

IRCCS Don Gnocchi

Milan, Lombardy, Italy

NOT YET RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, blood, cerebrospinal fluid

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carlo Ferrarese, MD, PhD

  University of Milano Bicocca

  STUDY CHAIR

Central Study Contacts

Federico Emanuele Pozzi, MD

CONTACT

+393494113421; federicoemanuele.pozzi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2033
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months after primary publication and ending 5 years thereafter.
• 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.

Locations

IT (5)