Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrolment
Participants undergo baseline assessments including clinical scales and imaging studies to identify biomarkers in Parkinsonian syndromes.
1 visit (in-person)
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
Actively Recruiting
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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