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NCT Number: NCT07457138

Lombard Cohort of Brain Health Services

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.

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Key information

Conditions

Subjective Cognitive Decline (SCD) Alzheimer Disease Alzheimer's Disease Brain Diseases Brain Health Central Nervous System Diseases Dementia Functional Cognitive Disorder Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Villa Beretta Rehabilitation Center, Costa Masnaga, Lombardy, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Emanuele Pozzi, MD

CONTACT

[email protected]

+393494113421

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Acronym: LoBHeS

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Mar 9, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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