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

Enrolling by invitation

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

In brief

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).

Key facts

Study ID

NCT07239843

Run by

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

People needed

1310

Starts

2026-02-01

Expected to finish

2029-12-30

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• IRSP — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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