Lombardy Brain Health Services cohort
Official title: Lombard Cohort of Brain Health Services
Run by University of Milano Bicocca · NCT07457138 · Data updated 2026-11-12
This project will see if a blood biomarker (pTau-217), together with clinical and cognitive tests, can help distinguish adults in Lombardy who have subjective cognitive decline, functional cognitive disorder, or are worried about their thinking.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 5 sites (Costa Masnaga, Lombardy and 4 other locations) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | February 1, 2028 |
| Study ends | February 1, 2033 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07457138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) seen at a Lombardy Brain Health Service with subjective cognitive decline, functional cognitive disorder, or who are well worried but have no objective cognitive impairment, and who can give written informed consent.
✕Probably not a fit
People already diagnosed with mild cognitive impairment or dementia, those enrolled in interventional trials affecting cognition, and pregnant or breastfeeding individuals are unlikely to benefit from this observational project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter prospective observational cohort of adults attending Brain Health Services in the Lombardy region. At baseline participants receive clinical and neuropsychological evaluations and blood sampling for AD biomarkers such as pTau-217, and biomarker results may be disclosed with monitoring of short-term psychological effects. The study compares people who are biomarker-positive versus biomarker-negative and looks for baseline predictors of positivity. Participants are followed longitudinally for up to five years to track biomarker trajectories and the possible development of mild cognitive impairment or dementia.
Why it matters
Potential benefit: If successful, the findings could help identify people at higher likelihood of Alzheimer's pathology earlier using blood tests and improve counseling and monitoring in clinic.
How similar studies have gone: Prior research has shown promising results for plasma pTau-217 and other blood biomarkers in detecting Alzheimer's pathology, but using them within Brain Health Services and studying the effects of risk disclosure is relatively new.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Villa Beretta Rehabilitation Center
Costa Masnaga, Lombardy, Italy Recruiting -
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy Recruiting -
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, Italy Recruiting -
IRCCS Auxologico
Milan, Lombardy, Italy Not yet recruiting -
IRCCS Don Gnocchi
Milan, Lombardy, Italy Not yet recruiting
Study contacts
- Study coordinator: Federico Emanuele Pozzi, MD
- Email: federicoemanuele.pozzi@gmail.com
- Phone: +393494113421
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Acoustic Stimulation During Sleep for Alzheimer’s Disease
Researchers test whether playing gentle sounds during sleep can help people with Alzheimer’s disease see if their thinking improves compared with a sham sound.
-
FAME: A Italian test to recognize famous faces and name them
This project tests an Italian battery to see how well people with stroke or neurodegenerative diseases recognize famous faces and recall their names, familiarity, and related facts.
-
Daily-life Virtual Reality Training to Support Thinking and Daily Tasks in adults 50 and older
A touchscreen-based daily-life VR program is being tested to see if it helps people 50+ improve daily activities and thinking skills, especially for those at risk of dementia.
-
Aging Brain Health Initiative in Fujian
This observational study will follow about 3,000 older adults in Fujian to see how Alzheimer's-related changes develop and to test new digital tests, biomarkers, and imaging tools for early diagnosis.
-
NMS-01 safety test in people with mild to moderate Alzheimer's disease
This pilot test checks whether the focused ultrasound device NMS-01 is safe and can briefly open the blood-brain barrier in adults with mild-to-moderate Alzheimer's disease.
-
Choose Myself (Before) Losing Myself
We’re testing an educational interactive booklet to help people with dementia or memory problems think about future medical decisions and start conversations with family or caregivers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.