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
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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ENROLLING_BY_INVITATION
1799 participants
OBSERVATIONAL
2026-01-01
2029-12-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
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
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
University of Ulm
OTHER
University Of Perugia
OTHER
University of Eastern Finland
OTHER
Responsible Party
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Olivia E Belbin, PhD
Dr
Locations
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Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Barcelona, Barcelona, Spain
Countries
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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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