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By invitation only NCT07239843

Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders

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

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

trial.available_in: БГ
Overview
This is a prospective observational study to identify sociodemographic factors that predict mental health outcomes in the European population and provide evidence linking common, modifiable sociodemographic risk factors for psychiatric symptoms with biological changes in patients suffering from a mental disorder (MD) or a neurodegenerative disease (ND).
Description
Sociodemographic studies in mental disorder (MD) and neurodegenerative diseases (ND). Sociodemographic factors increase the likelihood of developing an MD and contribute to poorer outcomes. There is less research on socioeconomic differences in ND, but also low socioeconomic status is also associated with dementia risk and early onset dementia. Substantial gaps remain in understanding the social and biological mechanisms underlying these disparities. Effective public health interventions to reduce the burden of these disorders are currently lacking.
Who can participate
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.
Locations 1
Spain (1)
IRSP
Barcelona , Barcelona
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.02.2026
Completion date
30.12.2029
Registry ID
NCT07239843
Source
clinicaltrials.gov
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