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

NCT ID: NCT07314190

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1799 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Alzheimer Disease Dementia With Lewy Bodies (DLB) Frontotemporal Dementia (FTD) Major Depressive Disorder (MDD) Bipolar 1 Disorder Schizophenia Disorder Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dementia with Lewy bodies

Clinical diagnosis of dementia with Lewy bodies

No interventions assigned to this group

Unaffected controls

No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease

No interventions assigned to this group

Frontotemporal dementia

Clinical diagnosis of frontotemporal dementia

No interventions assigned to this group

Major depressive disorder

Clinical diagnosis of major depressive disorder

No interventions assigned to this group

Bipolar disorder

Clinical diagnosis of type I + II Bipolar disorder

No interventions assigned to this group

Schizophrenia

Clinical diagnosis of schizophrenia

No interventions assigned to this group

Parkinson's disease

Clinical diagnosis of Parkinson's disease

No interventions assigned to this group

Alzheimer's disease

Clinical diagnosis of Alzheimer's disease

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

University of Ulm

OTHER

Sponsor Role collaborator

University Of Perugia

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

Responsible Party

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Olivia E Belbin, PhD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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101156566

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIBSP-ENT-2024-175

Identifier Type: -

Identifier Source: org_study_id

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