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OpenTrials
Active, Not Recruiting

NCT Number: NCT06501469

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parkinson Disease Atypical Parkinsonism Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinsonian Disorders Parkinsonism Pathological Conditions, Signs and Symptoms Primary Dysautonomias Progressive Supranuclear Palsy Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

HYGEIA Hospital, Parkinson's disease and Movement Disorders Department

Athens, 15123, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographics

    Time frame: At enrolment

    Age, gender, education, origin, race

  2. Family history

    Time frame: At enrolment

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

  3. Age

    Time frame: At enrolment

    Age at onset in years

  4. Disease duration

    Time frame: At enrolment

    Disease duration in years

  5. First motor symptom

    Time frame: At enrolment

    First motor symptom time of onset

  6. First non-motor symptom

    Time frame: At enrolment

    First non-motor symptom time of onset

  7. Side of onset

    Time frame: At enrolment

    Side of onset of first motor symptom

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. Imaging outcome measures - nuclear medicine investigations

    Time frame: At enrolment

    (meta-iodobenzylguanidine) MIBG-Scintigraphy heart

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

    Time frame: At enrolment

    fluorodeoxyglucose (FDG) -PET brain

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

    Time frame: At enrolment

    MRI brain

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

    Time frame: At enrolment

    MRI brain

  21. Blood samples analysis (DNA)

    Time frame: At enrolment

    Whole exome sequencing - genetic testing

  22. Blood samples analysis (biomarkers, exosomes)

    Time frame: At enrolment and after 2 years

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

Sponsors and collaborators

Lead sponsor

Non-profit organization for scientific research in Parkinson's disease and related disorders

Other

Collaborators

  • Biomedical Research Foundation, Academy of Athens

Registry information

Official study title

Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes

Acronym: PROATYP

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Jul 15, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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