Alzheimer DiseaseSynapsing-BKNCT07314190
Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder
An observational study of Alzheimer Disease and Dementia With Lewy Bodies (DLB), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD)
- How many people
- 1,799 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2026to 31 Dec 2029
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from specialized clinics at Barcelona (Spain), Perugia (Italy), Ulm (Germany), Halle (Germany) and Kuopio (Finland). Target % female in schizophrenia (30%), major depressive disorder (50%), bipolar disorder and controls (55%), Alzheimer's disease and controls (60%), frontotemporal dementia (65%), controls (65%). These percentages match those typically found in these disorders. Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site.
Who may be able to join
- Age>18 and donation of blood,
- full clinical and psychological assessment
- Available neuroimaging is optional as not all patients are suitable.
- Age and sex-matched unaffected volunteers without a MD or ND diagnosis are used as controls.
- Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site.
Who cannot join
- Lack of neuropsychological data,
- anticoagulant treatment such as acenocoumarol, heparin, warfarin, dabigatran, rivaroxaban, apixaban, drug abuse in the last year,
- medical history of cancer affecting the central nervous system that has not been in complete remission for 5 years or longer,
- the patient has received potentially neurotoxic chemotherapy and/or patient has received cranial radiotherapy.
- Clinical diagnosis of Alzheimer's disease where pathophysiological markers (measured in CSF or plasma) are inconsistent with Alzheimer's disease pathophysiology.
- Cognitively healthy volunteers where pathophysiological markers (measured in CSF or plasma) are consistent with Alzheimer's disease or other neurodegenerative pathophysiology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Barcelona, 08041
About this study
Official title: Synapsing Retrospective Biomarker Study
This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).
Read the detailed description
This study will collect clinical and biomarker data from patients and controls to identify a) a blood-based diagnostic biomarker for mental disorders, and b) a blood-based biomarker that could be used as a surrogate end-point for the principal neuropsychiatric symptoms.
Specific research questions are:
Can blood-based biomarkers provide a faster more objective diagnosis for major depressive disorder, bipolar disorders or schizophrenia? Can the same biomarkers also aid in the differential diagnosis from neurodegenerative diseases? Do blood-based synaptic biomarkers correlate with structural and functional brain changes, cognitive performance and psychiatric symptoms in patients with major depressive disorder, bipolar disorders, schizophrenia, Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia or Parkinson's disease? Can the blood-based synaptic biomarkers predict therapeutic response in patients with major depressive disorder, bipolar disorders or schizophrenia?
- Conditions
- Alzheimer Disease, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD), Bipolar 1 Disorder, Schizophenia Disorder
- Keywords
- Companion diagnostic biomarker, Synapse biomarker, magnetic resonance imaging, plasma, blood, serum
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia, Depressive Disorder, Major, Parkinson 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 |
|---|---|---|
| Major depressive disorder | Clinical diagnosis of major depressive disorder | |
| Bipolar disorder | Clinical diagnosis of type I + II Bipolar disorder | |
| Schizophrenia | Clinical diagnosis of schizophrenia | |
| Parkinson's disease | Clinical diagnosis of Parkinson's disease | |
| Alzheimer's disease | Clinical diagnosis of Alzheimer's disease | |
| Dementia with Lewy bodies | Clinical diagnosis of dementia with Lewy bodies | |
| Unaffected controls | No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease | |
| Frontotemporal dementia | Clinical diagnosis of frontotemporal dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of biomarkers in blood
Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques.
Measured: through study completion, an average of 1 year
Diagnosis
Primary diagnosis following evaluation by clinician and neuropsychologist
Measured: Baseline
Boston Naming Test
Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.
Measured: Up to 3-months
Secondary outcomes (1)
Structural brain changes
Acquisition of 3T-MRI with a high-resolution 3D T1-weighted anatomical image, a multi-shell diffusion-weighted MRI, and a resting-state functional sequence.
Measured: Up to 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start19 Feb 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,799 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, University Of Perugia, University of Eastern Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314190
- Sponsor's protocol ID
- IIBSP-ENT-2024-175
- Other IDs
- 101156566
- Acronym
- Synapsing-BK
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synapsing Retrospective Biomarker Study
- ClinicalTrials.gov ID
- NCT07314190
- Acronym / sponsor ID
- Synapsing-BK / IIBSP-ENT-2024-175
- Conditions
- Alzheimer Disease, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD), Bipolar 1 Disorder, Schizophenia Disorder
- Keywords
- Companion diagnostic biomarker, Synapse biomarker, magnetic resonance imaging, plasma, blood, serum
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,799 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- University of Ulm, University Of Perugia, University of Eastern Finland
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Jan 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.
This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).
Detailed description
This study will collect clinical and biomarker data from patients and controls to identify a) a blood-based diagnostic biomarker for mental disorders, and b) a blood-based biomarker that could be used as a surrogate end-point for the principal neuropsychiatric symptoms.
Specific research questions are:
Can blood-based biomarkers provide a faster more objective diagnosis for major depressive disorder, bipolar disorders or schizophrenia? Can the same biomarkers also aid in the differential diagnosis from neurodegenerative diseases? Do blood-based synaptic biomarkers correlate with structural and functional brain changes, cognitive performance and psychiatric symptoms in patients with major depressive disorder, bipolar disorders, schizophrenia, Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia or Parkinson's disease? Can the blood-based synaptic biomarkers predict therapeutic response in patients with major depressive disorder, bipolar disorders or schizophrenia?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | – | –Clinical diagnosis of major depressive disorder |
| Bipolar disorder | – | –Clinical diagnosis of type I + II Bipolar disorder |
| Schizophrenia | – | –Clinical diagnosis of schizophrenia |
| Parkinson's disease | – | –Clinical diagnosis of Parkinson's disease |
| Alzheimer's disease | – | –Clinical diagnosis of Alzheimer's disease |
| Dementia with Lewy bodies | – | –Clinical diagnosis of dementia with Lewy bodies |
| Unaffected controls | – | –No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease |
| Frontotemporal dementia | – | –Clinical diagnosis of frontotemporal dementia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from specialized clinics at Barcelona (Spain), Perugia (Italy), Ulm (Germany), Halle (Germany) and Kuopio (Finland). Target % female in schizophrenia (30%), major depressive disorder (50%), bipolar disorder and controls (55%), Alzheimer's disease and controls (60%), frontotemporal dementia (65%), controls (65%). These percentages match those typically found in these disorders. Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site.
Key inclusion criteria (5 listed)
- Age>18 and donation of blood,
- full clinical and psychological assessment
- Available neuroimaging is optional as not all patients are suitable.
- Age and sex-matched unaffected volunteers without a MD or ND diagnosis are used as controls.
- Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site.
Key exclusion criteria (6 listed)
- Lack of neuropsychological data,
- anticoagulant treatment such as acenocoumarol, heparin, warfarin, dabigatran, rivaroxaban, apixaban, drug abuse in the last year,
- medical history of cancer affecting the central nervous system that has not been in complete remission for 5 years or longer,
- the patient has received potentially neurotoxic chemotherapy and/or patient has received cranial radiotherapy.
- Clinical diagnosis of Alzheimer's disease where pathophysiological markers (measured in CSF or plasma) are inconsistent with Alzheimer's disease pathophysiology.
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
Concentration of biomarkers in blood
Time frame: through study completion, an average of 1 year
Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques.
Diagnosis
Time frame: Baseline
Primary diagnosis following evaluation by clinician and neuropsychologist
Boston Naming Test
Time frame: Up to 3-months
Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.
1 secondary outcome
Structural brain changes
Time frame: Up to 3-months
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 23 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia With Lewy Bodies (DLB), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of biomarkers in blood (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 23 Feb 2026.