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Parkinson DiseasePROATYPNCT06501469

Biomarkers in Parkinsonian Syndromes

An observational study of Parkinson Disease and Progressive Supranuclear Palsy, run by Non-profit organization for scientific research in Parkinson's disease and related disorders at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
How many people
200 participants
Where
1 siteGreece
Study dates
23 Mar 2022to 13 May 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

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

    Athens, Athens, 15123

Other trials in Greece

About this study

Official title: 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.

Keywords
Parkinson's disease, Progressive Supranuclear Palsy, Multiple System Atrophy, Atypical Parkinsonism, Parkinsonism, Biomarkers
Medical subject headings
Parkinson Disease, Supranuclear Palsy, Progressive, Multiple System Atrophy, Parkinsonian Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographics

    Age, gender, education, origin, race

    Measured: At enrolment

  2. Family history

    Family history of Parkinson's, dementia, tremor, other movement disorders, other neurological disorders

    Measured: At enrolment

  3. Age

    Age at onset in years

    Measured: At enrolment

  4. Disease duration

    Disease duration in years

    Measured: At enrolment

  5. First motor symptom

    First motor symptom time of onset

    Measured: At enrolment

  6. First non-motor symptom

    First non-motor symptom time of onset

    Measured: At enrolment

  7. Side of onset

    Side of onset of first motor symptom

    Measured: At enrolment

  8. Staging

    Hoehn and Yahr stage (H\&Y) stage (1-5, higher score indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  9. 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)

    Measured: At enrolment and every six months over 5 years

  10. Clinical scales for Progressive supranuclear palsy (PSP)

    Progressive supranuclear palsy rating scale (PSP-RS) (0-100; higher scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  11. Clinical scales for Multiple system atrophy (MSA)

    Unified Multiple system atrophy rating scale (UMSAPRS)(0-104; higher scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  12. Clinical scales for PSP short

    Progressive Supranuclear Palsy Clinical Deflicts Scale (PSP-CDS)(0-21; higher scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  13. Clinical scales for apathy

    Starkstein Apathy Scale (SAS) (0-56; higher scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  14. Clinical scale for autonomic dysfunction

    The Scale for Outcomes in Parkinson's disease for Autonomic symptoms - (0-100; higher scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  15. Clinical scale for cognition

    Montreal Cognitive Assessment (MOCA) (0-30, lower scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  16. Clinical scale for frontal dysfunction

    Frontal assessment battery (FAB) (0-18, lower scores indicate higher impairment)

    Measured: At enrolment and every six months over 5 years

  17. Imaging outcome measures - nuclear medicine investigations

    (meta-iodobenzylguanidine) MIBG-Scintigraphy heart

    Measured: At enrolment

  18. Imaging outcome measures - Positron emission tomography (PET)

    fluorodeoxyglucose (FDG) -PET brain

    Measured: At enrolment

  19. Imaging outcome measures - Dopamine Transporters imaging (DaTScan)

    MRI brain

    Measured: At enrolment

  20. Imaging outcome measures - Magnetic resonance imaging (MRI)

    MRI brain

    Measured: At enrolment

  21. Blood samples analysis (DNA)

    Whole exome sequencing - genetic testing

    Measured: At enrolment

  22. Blood samples analysis (biomarkers, exosomes)

    Peripheral blood mononuclear cell (PBMCs), peripheral blood mononuclear cells, exosomes

    Measured: At enrolment and after 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start23 Mar 2022
  3. Primary completion13 May 2031 (estimated)
  4. Study completion13 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501469
Sponsor's protocol ID
642
Acronym
PROATYP
Status last verified
Jun 2026
First submitted
20 Jun 2024
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Progressive Supranuclear Palsy, run by Non-profit organization for scientific research in Parkinson's disease and related disorders at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographics (time frame: At enrolment). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06501469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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