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ID06501469

Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes

Led by Non-profit organization for scientific research in Parkinson's disease and related disorders · Updated on 2024-07-17

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

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

Lead Sponsor

B

Biomedical Research Foundation, Academy of Athens

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a prospective observational study to identify biomarkers in parkinsonian syndromes. The study focuses on patients in the early stages of these diseases, aiming to follow them until their clinical diagnosis is confirmed or for at least five years. This research collects imaging, wet biomarkers, and clinical data systematically to better understand these conditions. Participants include those with parkinsonian syndromes and healthy individuals without neurological diseases. The study collects various imaging outcomes such as nuclear medicine investigations, PET scans, DaTScan, and MRI at enrolment. Blood samples for DNA and biomarkers are taken at enrolment and after two years. Clinical scales for Parkinson's disease, progressive supranuclear palsy, multiple system atrophy, apathy, autonomic dysfunction, cognition, and frontal dysfunction are assessed every six months for up to five years. During the study, participants undergo regular evaluations including clinical scales, disease staging, and imaging tests. Blood samples are analyzed at specific intervals. The primary outcomes include demographics, family history, disease duration, symptom onset, and progression measured through clinical scales and imaging. This observational study lasts at least five years, with ongoing monitoring and data collection to track disease evolution and biomarker changes.

CONDITIONS

Brief Title

Biomarkers in Parkinsonian Syndromes

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent, including consent to monitoring
  • Patients with Parkinsonism and disease duration less than 2 years
  • Patients with Parkinsonism and disease duration more than 2 years
  • Healthy individuals without any neurological disease
Not Eligible

You will not qualify if you...

  • Drug-induced parkinsonism (e.g., neuroleptics, lithium, valproic acid, metoclopramide)
  • Metabolic conditions related parkinsonism (e.g., Wilson's disease, hypoparathyroidism)
  • Structural lesions on brain MRI explaining symptoms, such as normal pressure hydrocephalus, moderate to severe chronic vascular encephalopathy, cerebral infarction, neoplasm
  • Other serious diseases indicating life expectancy less than 5 years
  • Active participation in other interventional clinical studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At enrolment

Participants undergo baseline assessments including clinical scales and imaging studies to identify biomarkers in Parkinsonian syndromes.

1 visit (in-person)

Long-term Monitoring

Duration - 5 years

Participants are monitored with clinical scales every six months over 5 years, with additional biomarker blood sample collections at enrolment and after 2 years.

Visits every 6 months for clinical assessments; blood samples collected at enrolment and after 2 years

Trial Site Locations

Total: 1 location

1

HYGEIA Hospital, Parkinson's disease and Movement Disorders Department

Athens, Greece, 15123

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Research Team

M

Maria Stamelou, Prof Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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