Alzheimer Disease, Bipolar 1 Disorder, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD), Parkinson Disease, Schizophenia Disorder
Conditions
Keywords
magnetic resonance imaging, sociodemographic, biomarker, plasma, serum, blood
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.
Interventions
None listed
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
University of Ulm
University Of Perugia
University of Eastern Finland
Martin-Luther-Universität Halle-Wittenberg
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis | 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). |
| Perceived Wellbeing and Mental Health | 2-months after enrollment | Total Score on the Perceived Wellbeing and Mental Health section of the survey |
| Social support | 2-months after enrolment | Total score on the Social support section of the sociodemographic survey |
| Socioeconomic background | 2-months after enrollment | Total score on the Socioeconomic background section of the sociodemographic survey |
| Health behaviour | 2-months after enrollment | Total score on the Health behaviour section of the sociodemographic survey |
| Hamilton Depression Rating Scale | 2-months after enrollment | Total score on the Hamilton Depression Rating Scale |
| Boston Naming Test | 2-months after enrollment | Total score on the Boston Naming Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural brain changes | 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. |
| Synaptic biomarker | Blood extracted 2-months after enrollment | Plasma concentration of (e.g., NPTX2) measured in plasma |
Countries
Spain
Outcome results
None listed