Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder

NCT07314190 | Enrolling By Invitation DMC

• 2 other identifiers: IIBSP-ENT-2024-175101156566
• Study Type: observational
• Target: 1,799
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).

Conditions

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

Keywords

Companion diagnostic biomarker; Synapse biomarker; magnetic resonance imaging; plasma; blood; serum

Outcome Measures

Primary Outcomes (3)

• Concentration of biomarkers in blood

  Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques.

  through study completion, an average of 1 year

• Diagnosis

  Primary diagnosis following evaluation by clinician and neuropsychologist

  Baseline

• Boston Naming Test

  Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.

  Up to 3-months

Secondary Outcomes (1)

• Structural brain changes

  Up to 3-months

Study Arms (8)

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

Frontotemporal dementia

Clinical diagnosis of frontotemporal dementia

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.

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

Study Sites (1)

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

Barcelona, 08041, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma and serum)

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 2, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)