Biomarkers in Parkinsonian Syndromes (PROATYP)

Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Parkinsonism; Multiple System Atrophy; Progressive Supranuclear Palsy; Atypical Parkinsonism

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Greece
  • Athens
    • Athens, Athens, Greece, 15123
      • HYGEIA Hospital, Parkinson's disease and Movement Disorders Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• patients with unclassified Parkinsonism and disease duration < 2 years
• patients with suggestive, possible or probable progressive suprnanuclear palsy (PSP) according to established clinical criteria
• patients with possible, probable or clinically confirmed multiple system atrophy (MSA) according to established clinical criteria
• patients with Parkinson's disease (PD) according to established clinical criteria

Description

IΙnclusion Criteria:

• Written informed consent, including consent to monitoring
• Patients with Parkinsonism and disease duration < 2 years
• Patients with Parkinsonism and disease duration > 2 years
• Healthy individuals without any neurological disease

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Non-profit organization for scientific research in Parkinson's disease and related disorders
• Collaborators: Biomedical Research Foundation, Academy of Athens
• Investigators: Principal Investigator: Maria Stamelou, Prof Dr, Hygeia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): May 13, 2031
• Study Completion (Estimated): May 13, 2031

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Progressive Supranuclear Palsy; Biomarkers; Parkinson's disease; Multiple System Atrophy; Parkinsonism; Atypical Parkinsonism
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Cranial Nerve Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Parkinsonian Disorders
• Other Study ID Numbers: 642

Drug and device information, study documents

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