Subjective Cognitive Decline (SCD)LoBHeSNCT07457138
Lombard Cohort of Brain Health Services
An observational study of Subjective Cognitive Decline (SCD) and Functional Cognitive Disorder, run by University of Milano Bicocca at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjective Cognitive Decline (SCD), Functional Cognitive Disorder, Alzheimer's Disease
- How many people
- 1,000 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Feb 2026to 1 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects accessing BHS in Lombardy with SCD, FCD or "well worried" individuals without objective cognitive impairment
Who may be able to join
- 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
Who cannot join
- Diagnosis of mild cognitive impairment or dementia at baseline visit
- Enrollment in another interventional study with an expected effect on cognition
- Pregnancy or breastfeeding
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Villa Beretta Rehabilitation Center
Costa Masnaga, Lombardy
Carlo Ferrarese, +393471514139, carlo.ferrarese@unimib.it
Franco Molteni, MD
- Not yet recruiting
IRCCS Auxologico
Milan, Lombardy
- Not yet recruiting
IRCCS Don Gnocchi
Milan, Lombardy
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900
Federico Emanuele Pozzi, MD, +393494113421, federicoemanuele.pozzi@gmail.com
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, 20097
Federico Emanuele Pozzi, MD, +393494113421, federicoemanuele.pozzi@gmail.com
Federico Emanuele Pozzi, MD
About this study
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:
Read more
- 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
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brain Health Service users | Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (first visit at Brain Health Service)
Secondary outcomes (3)
Psychological impact of biomarker disclosure at1 week
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.
Measured: Baseline (pre-disclosure) and 1 week after biomarker disclosure
Predictors of AD plasma biomarker positivity at baseline
Identification of demographic, clinical, neuropsychological, and radiological predictors of baseline AD plasma biomarker positivity, assessed using logistic and regression models.
Measured: Baseline
Predictors of longitudinal changes in AD biomarkers
Identification of clinical, neuropsychological, and radiological predictors of longitudinal changes in plasma AD biomarkers over time using linear mixed-effects models.
Measured: Baseline through 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Ferrarese, MD, PhD, Study chair, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457138
- Sponsor's protocol ID
- LoBHeS
- Acronym
- LoBHeS
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications (including demographic, clinical, neuropsychological, biomarker, and imaging-derived variables) will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lombard Cohort of Brain Health Services
- ClinicalTrials.gov ID
- NCT07457138
- Acronym / sponsor ID
- LoBHeS / LoBHeS
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Health Service users | – | –Adults with either Subjective Cognitive Decline, Functional Cognitive Disorder or Well Worried accessing Brain Health Services for dementia risk assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects accessing BHS in Lombardy with SCD, FCD or "well worried" individuals without objective cognitive impairment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of mild cognitive impairment or dementia at baseline visit
- Enrollment in another interventional study with an expected effect on cognition
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Psychological impact of biomarker disclosure at1 week
Time frame: Baseline (pre-disclosure) and 1 week after biomarker disclosure
Predictors of AD plasma biomarker positivity at baseline
Time frame: Baseline
Predictors of longitudinal changes in AD biomarkers
Time frame: Baseline through 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications (including demographic, clinical, neuropsychological, biomarker, and imaging-derived variables) will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo Ferrarese, MD, PhD study chair
University of Milano Bicocca
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjective Cognitive Decline (SCD) and Functional Cognitive Disorder, run by University of Milano Bicocca at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Emanuele Pozzi, MD (+393494113421, federicoemanuele.pozzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, neuropsychological, and biological patterns associated with AD plasma biomarker positivity at baseline (time frame: Baseline (first visit at Brain Health Service)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.