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

Synapsing's Multinational Sociodemographic Study

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Alzheimer Disease; Major Depressive Disorder (MDD); Bipolar 1 Disorder; Dementia With Lewy Bodies (DLB); Frontotemporal Dementia (FTD); Schizophenia Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 1310

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08004
      • IRSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural brain changes	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.	2 months after enrollment
Synaptic biomarker	Plasma concentration of (e.g., NPTX2) measured in plasma	Blood extracted 2-months after enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; blood; biomarker; serum; plasma; sociodemographic
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Mood Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Depressive Disorder; Frontotemporal Lobar Degeneration; Nutritional and Metabolic Diseases; Alzheimer Disease; Depressive Disorder, Major; Parkinson Disease; Frontotemporal Dementia; Lewy Body Disease
• Other Study ID Numbers: IIBSP-EPM-2024-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No