Biomarkers in Parkinsonian Syndromes (PROATYP)

June 16, 2026 updated by: Non-profit organization for scientific research in Parkinson's disease and related disorders

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: At enrolment
Age, gender, education, origin, race
At enrolment
Family history
Time Frame: At enrolment
Family history of Parkinson's, dementia, tremor, other movement disorders, other neurological disorders
At enrolment
Age
Time Frame: At enrolment
Age at onset in years
At enrolment
Disease duration
Time Frame: At enrolment
Disease duration in years
At enrolment
First motor symptom
Time Frame: At enrolment
First motor symptom time of onset
At enrolment
First non-motor symptom
Time Frame: At enrolment
First non-motor symptom time of onset
At enrolment
Side of onset
Time Frame: At enrolment
Side of onset of first motor symptom
At enrolment
Imaging outcome measures - nuclear medicine investigations
Time Frame: At enrolment
(meta-iodobenzylguanidine) MIBG-Scintigraphy heart
At enrolment
Imaging outcome measures - Positron emission tomography (PET)
Time Frame: At enrolment
fluorodeoxyglucose (FDG) -PET brain
At enrolment
Imaging outcome measures - Magnetic resonance imaging (MRI)
Time Frame: At enrolment
MRI brain
At enrolment
Blood samples analysis (DNA)
Time Frame: At enrolment
Whole exome sequencing - genetic testing
At enrolment
Blood samples analysis (biomarkers, exosomes)
Time Frame: At enrolment and after 2 years
Peripheral blood mononuclear cell (PBMCs), peripheral blood mononuclear cells, exosomes
At enrolment and after 2 years
Staging
Time Frame: At enrolment and every six months over 5 years
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
Time Frame: At enrolment and every six months over 5 years
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
Time Frame: At enrolment and every six months over 5 years
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)
Time Frame: At enrolment
MRI brain
At enrolment
Clinical scales - Unified Parkinson's disease rating scale (UPDRS)
Time Frame: 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)
At enrolment and every six months over 5 years
Clinical scales for Progressive supranuclear palsy (PSP)
Time Frame: At enrolment and every six months over 5 years
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)
Time Frame: At enrolment and every six months over 5 years
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
Time Frame: At enrolment and every six months over 5 years
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
Time Frame: At enrolment and every six months over 5 years
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
Time Frame: 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)
At enrolment and every six months over 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Non-profit organization for scientific research in Parkinson's disease and related disorders

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biomedical Research Foundation, Academy of Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Stamelou, Prof Dr, Hygeia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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