Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07752355

Conditions

Young Onset Parkinson Disease

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Young Onset Parkinson Disease

Parkinson Disease

Study ID

NCT07752355

Start date

Feb 28, 2024

Status verified date

Aug, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

YOPD cohort:

1. Male or female 18 years or older (inclusive) of any race and ethnicity
2. 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
3. Willingness to undergo a skin punch biopsy

LOPD cohort:

1. Male or female 18 years or older (inclusive) of any race and ethnicity
2. Diagnosis of PD confirmed by a movement disorder specialist and with an age of onset after the age of 50 years

Healthy Control cohort:

1. Male or female 18 years or older (inclusive) of any race and ethnicity
2. Never been diagnosed with PD as reported by medical history and as assessed by study PI

Exclusion Criteria:

1. 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).
2. Clinical history of autoimmune or chronic inflammatory disorder or exposure to chronic immunosuppressant or immunomodulatory medications.
3. Pregnancy
4. Dermatological conditions that would prevent performing skin punch biopsies

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Young-Onset Parkinson's Disease (YOPD) Patients

Clinical assessment:

  • History of PD
  • Medical history
  • Assessment of motor and non-motor symptoms of PD through standard rating scales

Biological samples:

  • Peripheral blood sample for the study of genetic and multi-omics data
  • Skin punch biopsy (3mm) for the assessment of the Alpha-Synuclein seeding amplification (SAA) Assay

For a sub-cohort of subjects:

\- Lumbar puncture for the collection of spinal fluid for the study of biological profiles

Late-Onset Parkinson's Disease (LOPD) Patients

Clinical assessment:

  • History of PD
  • Medical history
  • Assessment of motor and non-motor symptoms of PD through standard rating scales

Biological samples:

  • Peripheral blood sample for the study of genetic and multi-omics data
  • Skin punch biopsy (3mm) for the assessment of the Alpha-Synuclein seeding amplification (SAA) Assay

For a sub-cohort of subjects:

Lumbar puncture for the collection of spinal fluid for the study of biological profiles

Healthy Controls

Clinical assessment:

  • Medical history
  • Assessment of motor and non-motor symptoms of PD through standard rating scales

Biological samples:

  • Peripheral blood sample for the study of genetic and multi-omics data
  • Skin punch biopsy (3mm) for the assessment of the Alpha-Synuclein seeding amplification (SAA) Assay

For a sub-cohort of subjects:

Lumbar puncture for the collection of spinal fluid for the study of biological profiles

Primary outcome measure

  • Alpha-Synuclein seeding amplification (SAA) Assay Results [ Time Frame: Baseline ]
  • Genetic test results [ Time Frame: Baseline ]
  • Differences in clinical profiles [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Young Onset Parkinson Disease
  • Parkinson Disease
  • Early Onset Parkinson Disease
  • EOPD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-12.