Biomarkers in Parkinsonian Syndromes
NCT Number: NCT06501469
Acronym: PROATYP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease|Progressive Supranuclear Palsy|Multiple System Atrophy|Atypical Parkinsonism|Parkinsonism
Sponsor: Non-profit organization for scientific research in Parkinson's disease and related disorders
Collaborators: Biomedical Research Foundation, Academy of Athens
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-23
Completion Date: 2030-03-25
Locations: HYGEIA Hospital, Parkinson's disease and Movement Disorders Department, Athens, 15123, Greece

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.

Primary Outcome Measures: 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