Lombardy Brain Health Services cohort
Lombard Cohort of Brain Health Services
University of Milano Bicocca · NCT07457138
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca (other) |
| Locations | 5 sites (Costa Masnaga, Lombardy and 4 other locations) |
| Trial ID | NCT07457138 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Costa Masnaga, Lombardy and 4 other locations
- 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, Italy (RECRUITING)
- IRCCS Policlinico San Donato — San Donato Milanese, Lombardy, Italy (RECRUITING)
Study contacts
- Study coordinator: Federico Emanuele Pozzi, MD
- Email: federicoemanuele.pozzi@gmail.com
- Phone: +393494113421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Subjective Cognitive Decline, Functional Cognitive Disorder, Alzheimer's Disease, Brain Health, Brain Health Services, pTau-217, GFAP, NfL