Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Non-profit organization for scientific research in Parkinson's disease and related disorders
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Blood samples analysis (DNA)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Blood samples analysis (DNA)
Time Frame: At enrolment
Whole exome sequencing - genetic testing
Age
Time Frame: At enrolment
Age at onset in years
First motor symptom
Time Frame: At enrolment
First motor symptom time of onset
Disease duration
Time Frame: At enrolment
Disease duration in years
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)
Imaging outcome measures - nuclear medicine investigations
Time Frame: At enrolment
(meta-iodobenzylguanidine) MIBG-Scintigraphy heart
First non-motor symptom
Time Frame: At enrolment
First non-motor symptom time of onset
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)
Imaging outcome measures - Positron emission tomography (PET)
Time Frame: At enrolment
fluorodeoxyglucose (FDG) -PET brain
Imaging outcome measures - Dopamine Transporters imaging (DaTScan)
Time Frame: At enrolment
MRI brain
Side of onset
Time Frame: At enrolment
Side of onset of first motor symptom
Demographics
Time Frame: At enrolment
Age, gender, education, origin, race
Family history
Time Frame: At enrolment
Family history of Parkinson's, dementia, tremor, other movement disorders, other neurological disorders
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)
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)
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)
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)
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)
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)
Imaging outcome measures - Magnetic resonance imaging (MRI)
Time Frame: At enrolment
MRI brain
Blood samples analysis (biomarkers, exosomes)
Time Frame: At enrolment and after 2 years
Peripheral blood mononuclear cell (PBMCs), peripheral blood mononuclear cells, exosomes
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)