Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Synapsing Retrospective Biomarker Study
Overview
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?
Primary outcome measures
- Concentration of biomarkers in blood [Time frame: through study completion, an average of 1 year]
- Diagnosis [Time frame: Baseline]
- Boston Naming Test [Time frame: Up to 3-months]
Secondary outcome measures (1)
- Structural brain changes [Time frame: Up to 3-months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau — Barcelona
Identifiers
NCT: NCT07314190 · IIBSP-ENT-2024-175 · 101156566