Biomarkers in Parkinsonian Syndromes

NCT06501469 | Recruiting DMC

• 1 other identifier: 642
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Progressive Supranuclear Palsy; Multiple System Atrophy; Atypical Parkinsonism; Parkinsonism

Keywords

Parkinson's disease; Progressive Supranuclear Palsy; Multiple System Atrophy; Atypical Parkinsonism; Parkinsonism; Biomarkers

Outcome Measures

Primary Outcomes (22)

• 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

• 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 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

• 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 - 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 - Dopamine Transporters imaging (DaTScan)

  MRI 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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) and disease duration \<2 years according to established clinical criteria * patients with possible, probable or clinically confirmed multiple system atrophy (MSA) and disease duration \<2 years according to established clinical criteria * patients with parkinsonism (PD, MSA or PSP) and disease duration \> 2 years according to established clinical criteria * patients with Parkinson's disease (PD) and disease duration \< 2 years according to established clinical criteria * patients with Parkinson's disease (PD) and disease duration \> 2 years according to established clinical criteria * healthy individuals without any neurological disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Non-profit organization for scientific research in Parkinson's disease and related disorders: lead
• Biomedical Research Foundation, Academy of Athens: collaborator

Study Sites (1)

HYGEIA Hospital, Parkinson's disease and Movement Disorders Department

Athens, 15123, Greece

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive; Multiple System Atrophy; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Maria Stamelou, Prof Dr

  HYGEIA Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Stamelou, Prof Dr

CONTACT

+302106867303; mstamelou@hygeia.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 15, 2024
• Study Start: March 23, 2022
• Primary Completion (Estimated): March 25, 2029
• Study Completion (Estimated): March 25, 2030
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

GR (1)