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

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

Synapsing Retrospective Biomarker Study

NCT07314190•Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

View on ClinicalTrials.gov

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).

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?

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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)

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

Barcelona, Spain

Key Dates

Start Date

February 19, 2026

Primary Completion Date

June 30, 2029

Completion Date

December 31, 2029

Last Updated

February 23, 2026

Enrollment

1,799

ESTIMATED participants

Conditions

Alzheimer DiseaseDementia With Lewy Bodies (DLB)Frontotemporal Dementia (FTD)Major Depressive Disorder (MDD)Bipolar 1 DisorderSchizophenia DisorderParkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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