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

NCT07239843 | Enrolling By Invitation

• 1 other identifier: IIBSP-EPM-2024-176
• Study Type: observational
• Target: 1,310
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

magnetic resonance imaging; sociodemographic; biomarker; plasma; serum; blood

Outcome Measures

Primary Outcomes (7)

• Diagnosis

  Primary diagnosis following evaluation by clinician and neuropsychologist or information relating to a previous or current MD/ND diagnosis or mental health issue (Anxiety disorders, behavioural and emotional disorder in children, bipolar affective disorders, depression, dissociation and dissociative disorders, eating disorders, obsessive compulsive disorder, paranoia, post-traumatic stress disorder or psychosis).

  2-months after enrollment

• Perceived Wellbeing and Mental Health

  Total Score on the Perceived Wellbeing and Mental Health section of the survey

  2-months after enrollment

• Social support

  Total score on the Social support section of the sociodemographic survey

  2-months after enrolment

• Socioeconomic background

  Total score on the Socioeconomic background section of the sociodemographic survey

  2-months after enrollment

• Health behaviour

  Total score on the Health behaviour section of the sociodemographic survey

  2-months after enrollment

• Hamilton Depression Rating Scale

  Total score on the Hamilton Depression Rating Scale

  2-months after enrollment

• Boston Naming Test

  Total score on the Boston Naming Test

  2-months after enrollment

Secondary Outcomes (2)

• Structural brain changes

  2 months after enrollment

• Synaptic biomarker

  Blood extracted 2-months after enrollment

Study Arms (7)

major depressive disorder

Clinical diagnosis of major depressive disorder

Bipolar disorder

Clinical diagnosis of type I + II Bipolar disorder

Schizophrenia

Clinical diagnosis of schizophrenia

Parkinson's disease

Clinical diagnosis of Parkinson's disease

Alzheimer's disease

Clinical diagnosis of Alzheimer's disease

Dementia with Lewy bodies

Clinical diagnosis of dementia with Lewy bodies

Unaffected controls

No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from specialized clinics at Barcelona (Spain), Perugia (Italy), Ulm (Germany), Halle (Germany) and Kuopio (Finland). Target % female in schizophrenia (30%), major depressive disorder (50%), bipolar disorder and controls (55%), Alzheimer's disease and controls (60%), frontotemporal dementia (65%), controls (65%). These percentages match those typically found in these disorders. Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site. This study also includes participants from a wider European population of people with a lived experience of mental health issues from six focus countries of Europe, UK, Spain, Germany, Finland, Italy and Ireland.

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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• University of Ulm: collaborator
• University Of Perugia: collaborator
• University of Eastern Finland: collaborator
• Martin-Luther-Universität Halle-Wittenberg: collaborator

Study Sites (1)

IRSP

Barcelona, Barcelona, 08004, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, serum)

MeSH Terms

Conditions

Depressive Disorder, Major; Alzheimer Disease; Parkinson Disease; Frontotemporal Dementia; Lewy Body Disease

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)