Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder (Synapsing-BK)

February 19, 2026 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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).

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

1799

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
Major depressive disorder
Clinical diagnosis of major depressive disorder
Frontotemporal dementia
Clinical diagnosis of frontotemporal dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
Diagnosis
Time Frame: Baseline
Primary diagnosis following evaluation by clinician and neuropsychologist
Baseline
Boston Naming Test
Time Frame: Up to 3-months
Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.
Up to 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural brain changes
Time Frame: Up to 3-months
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.
Up to 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

University Of Perugia
University of Ulm
University of Eastern Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ENT-2024-175
  • 101156566 (Other Grant/Funding Number: EU Horizon Europe)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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