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

NCT07314190 — Enrolling by invitation, 1799 participants, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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Synapsing Retrospective Biomarker Study

RegistryNCT07314190, acronym Synapsing-BK
StatusEnrolling by invitation
Study typeObservational
Enrollment1799 (Estimated)
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other); collaborators: University of Ulm, University Of Perugia, University of Eastern Finland
ConditionsAlzheimer Disease, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD), Bipolar 1 Disorder, Schizophenia Disorder, Parkinson Disease
Datesstart 2026-02-19, primary completion 2029-06-30 (estimated), completion 2029-12-31 (estimated), first posted 2026-01-02, last updated 2026-02-23
Locations1 site in Spain

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-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).

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+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?

+Arms and interventions

ArmTypeInterventionsDescription
Major depressive disorderClinical diagnosis of major depressive disorder
Bipolar disorderClinical diagnosis of type I + II Bipolar disorder
SchizophreniaClinical diagnosis of schizophrenia
Parkinson's diseaseClinical diagnosis of Parkinson's disease
Alzheimer's diseaseClinical diagnosis of Alzheimer's disease
Dementia with Lewy bodiesClinical diagnosis of dementia with Lewy bodies
Unaffected controlsNo clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease
Frontotemporal dementiaClinical diagnosis of frontotemporal dementia

+Outcome measures

Primary outcomes

  • Concentration of biomarkers in blood [through study completion, an average of 1 year]: Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques.
  • Diagnosis [Baseline]: Primary diagnosis following evaluation by clinician and neuropsychologist
  • Boston Naming Test [Up to 3-months]: Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.

Secondary outcomes

  • Structural brain changes [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant PauBarcelonaSpain