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

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

Status: Invitation-only

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

Study type: Observational

Funder types: Other

Identifiers

NCT07314190

IIBSP-ENT-2024-175

101156566 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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?

Enrollment: 1,799 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,799 participants in 8 patient groups

Major depressive disorder

Description:

Clinical diagnosis of major depressive disorder

Bipolar disorder

Description:

Clinical diagnosis of type I + II Bipolar disorder

Schizophrenia

Description:

Clinical diagnosis of schizophrenia

Parkinson's disease

Description:

Clinical diagnosis of Parkinson's disease

Alzheimer's disease

Description:

Clinical diagnosis of Alzheimer's disease

Dementia with Lewy bodies

Description:

Clinical diagnosis of dementia with Lewy bodies

Unaffected controls

Description:

No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease

Frontotemporal dementia

Description:

Clinical diagnosis of frontotemporal dementia