Clinical trial NCT06501469: Biomarkers in Parkinsonian Syndromes
Official title: Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Non-profit organization for scientific research in Parkinson's disease and related disorders
Sponsor class: OTHER
Collaborators: name: Biomedical Research Foundation, Academy of Athens
First posted: 2024-07-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: IΙnclusion Criteria:

* Written informed consent, including consent to monitoring
* Patients with Parkinsonism and disease duration \< 2 years
* Patients with Parkinsonism and disease duration \> 2 years
* Healthy individuals without any neurological disease

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

Primary outcomes:
measure: Demographics
timeFrame: At enrolment
measure: Family history
timeFrame: At enrolment
measure: Age
timeFrame: At enrolment
measure: Disease duration
timeFrame: At enrolment
measure: First motor symptom
timeFrame: At enrolment
measure: First non-motor symptom
timeFrame: At enrolment
measure: Side of onset
timeFrame: At enrolment
measure: Staging
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scales - Unified Parkinson's disease rating scale (UPDRS)
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scales for Progressive supranuclear palsy (PSP)
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scales for Multiple system atrophy (MSA)
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scales for PSP short
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scales for apathy
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scale for autonomic dysfunction
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scale for cognition
timeFrame: At enrolment and every six months over 5 years
measure: Clinical scale for frontal dysfunction
timeFrame: At enrolment and every six months over 5 years
measure: Imaging outcome measures - nuclear medicine investigations
timeFrame: At enrolment
measure: Imaging outcome measures - Positron emission tomography (PET)
timeFrame: At enrolment
measure: Imaging outcome measures - Dopamine Transporters imaging (DaTScan)
timeFrame: At enrolment
measure: Imaging outcome measures - Magnetic resonance imaging (MRI)
timeFrame: At enrolment
measure: Blood samples analysis (DNA)
timeFrame: At enrolment
measure: Blood samples analysis (biomarkers, exosomes)
timeFrame: At enrolment and after 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: HYGEIA Hospital, Parkinson's disease and Movement Disorders Department
Study officials:
affiliation: HYGEIA Hospital
name: Maria Stamelou, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: