Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07239843

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

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).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

About this study

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

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnosis

    Time frame: 2-months after enrollment

    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. Perceived Wellbeing and Mental Health

    Time frame: 2-months after enrollment

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

  3. Social support

    Time frame: 2-months after enrolment

    Total score on the Social support section of the sociodemographic survey

  4. Socioeconomic background

    Time frame: 2-months after enrollment

    Total score on the Socioeconomic background section of the sociodemographic survey

  5. Health behaviour

    Time frame: 2-months after enrollment

    Total score on the Health behaviour section of the sociodemographic survey

  6. Hamilton Depression Rating Scale

    Time frame: 2-months after enrollment

    Total score on the Hamilton Depression Rating Scale

  7. Boston Naming Test

    Time frame: 2-months after enrollment

    Total score on the Boston Naming Test

Secondary outcomes

  1. Structural brain changes

    Time frame: 2 months after enrollment

    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. Synaptic biomarker

    Time frame: Blood extracted 2-months after enrollment

    Plasma concentration of (e.g., NPTX2) measured in plasma

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Martin-Luther-Universität Halle-Wittenberg
  • University Of Perugia
  • University of Eastern Finland
  • University of Ulm

Registry information

Official study title

Synapsing's Multinational Sociodemographic Study

Acronym: Synapsing-SD

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Nov 20, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.