Young Onset Parkinson DiseaseYOPDNCT07752355
Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms
An observational study of Young Onset Parkinson Disease and Parkinson Disease, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Young Onset Parkinson Disease, Parkinson Disease
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or Female subjects with Parkinson disease and non-affected subjects 18 years of age or older.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Astudillo contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Young Onset Parkinson Disease, Parkinson Disease
- Keywords
- Young Onset Parkinson Disease, Parkinson Disease, Early Onset Parkinson Disease, EOPD
- Medical subject headings
- Parkinsonian Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-Synuclein seeding amplification (SAA) Assay Results
Proportion of YOPD participants with positive of alpha-synuclein SAA in central (cerebrospinal fluid) peripheral biospecimens (skin biopsy)
Measured: Baseline
Genetic test results
Proportion of YOPD participants with positive genetic testing for gene mutations in known PD-associated genes
Measured: Baseline
Differences in clinical profiles
Differences of the clinical profiles related to motor and non-motor symptoms of PD in YOPD as measured by standard clinical rating scales
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start28 Feb 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young Onset Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Giulietta Riboldi, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752355
- Sponsor's protocol ID
- 23-00652
- Acronym
- YOPD
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an Observational study that is voluntarily registered, and is not subject to mandatory results reporting under FDAAA 801/the Final Rule. This observational study is registered specifically to increase visibility and boost recruitment.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms
- ClinicalTrials.gov ID
- NCT07752355
- Acronym / sponsor ID
- YOPD / 23-00652
- Conditions
- Young Onset Parkinson Disease, Parkinson Disease
- Keywords
- Young Onset Parkinson Disease, Parkinson Disease, Early Onset Parkinson Disease, EOPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or Female subjects with Parkinson disease and non-affected subjects 18 years of age or older.
Key inclusion criteria (10 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alpha-Synuclein seeding amplification (SAA) Assay Results
Time frame: Baseline
Proportion of YOPD participants with positive of alpha-synuclein SAA in central (cerebrospinal fluid) peripheral biospecimens (skin biopsy)
Genetic test results
Time frame: Baseline
Proportion of YOPD participants with positive genetic testing for gene mutations in known PD-associated genes
Differences in clinical profiles
Time frame: Baseline
Differences of the clinical profiles related to motor and non-motor symptoms of PD in YOPD as measured by standard clinical rating scales
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. This is an Observational study that is voluntarily registered, and is not subject to mandatory results reporting under FDAAA 801/the Final Rule. This observational study is registered specifically to increase visibility and boost recruitment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Astudillo contact
Giulietta Riboldi, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Young Onset Parkinson Disease and Parkinson Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Belio (646-501-4367, Mark.Belio@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-Synuclein seeding amplification (SAA) Assay Results (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.