Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Young Onset Parkinson Disease, Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Young Onset Parkinson's disease (YOPD) refers to a group of patients in which the disease starts earlier in life (before the age of 50 years) and has a profound impact on most of patient's life. Current knowledge regarding the mechanisms leading to development of Parkinson's disease in younger individuals is lacking, but their understanding is crucial for the successful design of therapeutic strategies and stratifying patients for clinical trials. With this research the investigators aim to clarify the contribution of relevant biological processes in patients with Young onset Parkinson's disease to help understanding disease mechanisms and biomarkers.
Detailed description
With the present project the investigators propose to study clinical and biological data (from peripheral blood and skin punch biopsy) in subjects with Young and Late Onset Parkinson's disease as well as non-affected subjects (controls) to identify characteristic biological traits for each for this groups.
For each participant, the investigators will collect information about demographic data, clinical data related to the symptoms of Parkinson's disease through standard questionnaire, a clinical exam, and standard interview. A blood sample (from a peripheral vein) and skin punch biopsy will be collected to study genetic and biological markers of the disease. The study duration for each participant is of one in-person visit at the study center.
In a subgroup of subjects, biological data from the lumbar puncture will be collected and analyzed as well.
Primary outcome measures
- Alpha-Synuclein seeding amplification (SAA) Assay Results [Time frame: Baseline]
- Genetic test results [Time frame: Baseline]
- Differences in clinical profiles [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
YOPD cohort:
- Male or female 18 years or older (inclusive) of any race and ethnicity
- Diagnosis of Parkinson's disease (PD) confirmed by a movement disorder specialist and with an age of onset of less than or equal to the age of 50 years old
- Willingness to undergo a skin punch biopsy
LOPD cohort:
- Male or female 18 years or older (inclusive) of any race and ethnicity
- Diagnosis of PD confirmed by a movement disorder specialist and with an age of onset after the age of 50 years
Healthy Control cohort:
- Male or female 18 years or older (inclusive) of any race and ethnicity
- Never been diagnosed with PD as reported by medical history and as assessed by study PI
Exclusion criteria
- Diagnosis of atypical parkinsonism (i.e. progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy) or secondary parkinsonism (i.e. normal pressure hydrocephalus, drug-induced parkinsonism).
- Clinical history of autoimmune or chronic inflammatory disorder or exposure to chronic immunosuppressant or immunomodulatory medications.
- Pregnancy
- Dermatological conditions that would prevent performing skin punch biopsies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07752355 · 23-00652