Biomarkers in Parkinsonian Syndromes

Recruiting

• Conditions: Parkinson Disease; Multiple System Atrophy; Parkinsonism; Progressive Supranuclear Palsy; Atypical Parkinsonism

• Registration Number: NCT06501469
• Lead Sponsor: Non-profit organization for scientific research in Parkinson's disease and related disorders

Brief Summary

This is a prospective observational study to identify biomarkers in parkinson syndromes. Patients with parkinsonian syndromes at the early stages of disease will be recruited and will be followed up until their established clinical diagnosis or for at least 5 years. In this population, imaging and wet biomarkers as well as clinical data will b systematically collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2029-03-25
• Study Completion: 2030-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

• Drug-induced parkinsonism (eg, neuroleptics, lithium, valproic acid, metoclopramide).
• Metabolic conditions related parkinsonism (eg, Wilson's disease, hypoparathyroidism).
• Structural lesions on brain magnetic resonance imaging (MRI) that explain the symptoms, such as normal pressure hydrocephalus, moderate to severe chronic vascular encephalopathy, cerebral infarction, neoplasm
• Other serious diseases that indicate a life expectancy of <5 years.
• Active participation in other interventional clinical studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First motor symptom	At enrolment	First motor symptom time of onset
Disease duration	At enrolment	Disease duration in years
Staging	At enrolment and every six months over 5 years	Hoehn and Yahr stage (H\&Y) stage (1-5, higher score indicate higher impairment)
Imaging outcome measures - nuclear medicine investigations	At enrolment	(meta-iodobenzylguanidine) MIBG-Scintigraphy heart
First non-motor symptom	At enrolment	First non-motor symptom time of onset
Clinical scale for frontal dysfunction	At enrolment and every six months over 5 years	Frontal assessment battery (FAB) (0-18, lower scores indicate higher impairment)
Imaging outcome measures - Positron emission tomography (PET)	At enrolment	fluorodeoxyglucose (FDG) -PET brain
Imaging outcome measures - Dopamine Transporters imaging (DaTScan)	At enrolment	MRI brain
Blood samples analysis (DNA)	At enrolment	Whole exome sequencing - genetic testing
Side of onset	At enrolment	Side of onset of first motor symptom
Demographics	At enrolment	Age, gender, education, origin, race
Family history	At enrolment	Family history of Parkinson's, dementia, tremor, other movement disorders, other neurological disorders
Age	At enrolment	Age at onset in years
Clinical scales for apathy	At enrolment and every six months over 5 years	Starkstein Apathy Scale (SAS) (0-56; higher scores indicate higher impairment)
Clinical scales - Unified Parkinson's disease rating scale (UPDRS)	At enrolment and every six months over 5 years	Unified Parkinson's disease rating scale I-IV (UPDRS I-IV, 0-260; higher scores indicate higher impairment)
Clinical scales for Progressive supranuclear palsy (PSP)	At enrolment and every six months over 5 years	Progressive supranuclear palsy rating scale (PSP-RS) (0-100; higher scores indicate higher impairment)
Clinical scales for Multiple system atrophy (MSA)	At enrolment and every six months over 5 years	Unified Multiple system atrophy rating scale (UMSAPRS)(0-104; higher scores indicate higher impairment)
Clinical scales for PSP short	At enrolment and every six months over 5 years	Progressive Supranuclear Palsy Clinical Deflicts Scale (PSP-CDS)(0-21; higher scores indicate higher impairment)
Clinical scale for autonomic dysfunction	At enrolment and every six months over 5 years	The Scale for Outcomes in Parkinson's disease for Autonomic symptoms - (0-100; higher scores indicate higher impairment)
Imaging outcome measures - Magnetic resonance imaging (MRI)	At enrolment	MRI brain
Blood samples analysis (biomarkers, exosomes)	At enrolment and after 2 years	Peripheral blood mononuclear cell (PBMCs), peripheral blood mononuclear cells, exosomes
Clinical scale for cognition	At enrolment and every six months over 5 years	Montreal Cognitive Assessment (MOCA) (0-30, lower scores indicate higher impairment)

Trial Locations

Locations (1)

HYGEIA Hospital, Parkinson's disease and Movement Disorders Department; 🇬🇷 Athens, Greece