ClinicalTrials.gg
RecruitingNCT07752355YOPDUpdated Aug 12, 2026

Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms

An observational study in Young Onset Parkinson Disease and Parkinson Disease, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Primary conditionParkinson DiseaseRegistry: Parkinsonian DisordersReclassifiedWhy we changed it
Registry
Parkinsonian Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Parkinson Disease
Why
  1. The study's listed conditions name Parkinson Disease, a narrower term within Parkinsonian Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by NYU Langone Health · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Parkinson Disease by NYU Langone Health — 3 open to participants now, 3 under way, none of them phase 3. Parkinson Disease · NYU Langone Health.

Started
2024
the only one that year
Observational
6 of 16
3 open now
Registered
15th of 16
by date

Among the 16 studies in Parkinson Disease by NYU Langone Health, this one is the only one that started in 2024, is one of 6 observational ones, and was the 15th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

3 of the 16 studies in Parkinson Disease by NYU Langone Health are open now, in 4 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Parkinson Disease by NYU Langone Health, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Young Onset Parkinson Disease
  • Parkinson Disease

Browse trials for

Keywords

  • Young Onset Parkinson Disease
  • Parkinson Disease
  • Early Onset Parkinson Disease
  • EOPD
04

In context

Parkinson Disease Reclassified

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

This study's planned enrollment of 250 is above the median of 96 across 1,086 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.

Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.

Compared within Parkinson Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Parkinsonian Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Male or Female subjects with Parkinson disease and non-affected subjects 18 years of age or older.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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 or chronic inflammatory disorder or exposure to chronic or immunomodulatory medications.
  3. Pregnancy
  4. Dermatological conditions that would prevent performing skin punch
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

07

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline

  2. Genetic test results

    Proportion of YOPD participants with positive genetic testing for gene mutations in known PD-associated genes

    Time frame: Baseline

  3. 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

    Time frame: Baseline

08

Study locations

1 of 1 sites recruiting
09

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Oct 2028, 56 months after the start.

Of 379 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 56 months is above that.

Counting every sponsor, half of 439 studies reached it within 47 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 7, 2026
StartActual
Feb 28, 2024
Primary completionEst.
Oct 31, 2028
CompletionEst.
Oct 31, 2028
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07752355
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Feb 28, 2024
Primary completion
Oct 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

Mark Belio
Contact
Mark.Belio@nyulangone.org
646-501-4367
Kelly Astudillo
Contact
Kelly.Astudillo@nyulangone.org
Giulietta Riboldi, MD, PhD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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