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Enrolling by Invitation

NCT Number: NCT07314190

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

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).

Enrolling by Invitation

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Key information

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Diagnosis

    Time frame: Baseline

    Primary diagnosis following evaluation by clinician and neuropsychologist

  3. Boston Naming Test

    Time frame: Up to 3-months

    Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • University Of Perugia
  • University of Eastern Finland
  • University of Ulm

Registry information

Official study title

Synapsing Retrospective Biomarker Study

Acronym: Synapsing-BK

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 2, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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