Alzheimer Disease, Bipolar 1 Disorder, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD), Parkinson Disease, Schizophenia Disorder
Conditions
Keywords
Companion diagnostic biomarker, Synapse biomarker, magnetic resonance imaging, plasma, blood, serum
Brief summary
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?
Interventions
None listed
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
University of Ulm
University Of Perugia
University of Eastern Finland
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of biomarkers in blood | through study completion, an average of 1 year | Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques. |
| Diagnosis | Baseline | Primary diagnosis following evaluation by clinician and neuropsychologist |
| Boston Naming Test | Up to 3-months | Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural brain changes | Up to 3-months | 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. |
Countries
Spain
Outcome results
None listed