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

N/AEnrolling By InvitationNCT07314190

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1,799 enrolled

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).

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?

Study Type

OBSERVATIONAL

Enrollment

1,799

Conditions

Alzheimer Disease Dementia With Lewy Bodies (DLB)Frontotemporal Dementia (FTD)Major Depressive Disorder (MDD)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Concentration of biomarkers in blood

Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques.

Time frame: through study completion, an average of 1 year

Diagnosis

Primary diagnosis following evaluation by clinician and neuropsychologist

Time frame: Baseline

Boston Naming Test

Total score on the Boston Naming Test

Time frame: Up to 3-months

Secondary Outcomes

Structural brain changes

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.