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

NCT ID: NCT07239843

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1310 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2029-12-30

Brief Summary

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).

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

major depressive disorder

Clinical diagnosis of major depressive disorder

No interventions assigned to this group

Bipolar disorder

Clinical diagnosis of type I + II Bipolar disorder

No interventions assigned to this group

Schizophrenia

Clinical diagnosis of schizophrenia

No interventions assigned to this group

Parkinson's disease

Clinical diagnosis of Parkinson's disease

No interventions assigned to this group

Alzheimer's disease

Clinical diagnosis of Alzheimer's disease

No interventions assigned to this group

Dementia with Lewy bodies

Clinical diagnosis of dementia with Lewy bodies

No interventions assigned to this group

Unaffected controls

No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ulm

OTHER

Sponsor Role: collaborator

University Of Perugia

OTHER

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRSP

Barcelona, , Spain

Countries

Spain

Other Identifiers

IIBSP-EPM-2024-176

Identifier Type: -

Identifier Source: org_study_id