--- title: Studying early onset biological markers nct_id: NCT07752355 status: RECRUITING sponsor: NYU Langone Health study_type: OBSERVATIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07752355" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07752355" last_fetched: "2026-08-08T14:01:06.618Z" source: "Parkinson's Pathways (curated)" --- # Studying early onset biological markers **Goal (in five words):** Studying early onset biological markers **Official Title:** Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms **Trial ID:** [NCT07752355](https://clinicaltrials.gov/study/NCT07752355) ## Key Facts - **Status:** RECRUITING - **Study Type:** OBSERVATIONAL - **Sponsor:** NYU Langone Health - **Target Enrollment:** 250 participants - **Start Date:** 2024-02-28 - **Completion Date:** 2028-10-31 - **Conditions:** Young Onset Parkinson Disease, Parkinson Disease - **Registry Record Last Updated:** 2026-08-07 (this month) ## Summary For Families The team wants to find what biological processes make Parkinson's start younger in some people, so they can better understand causes and find measurable biological signs to guide future treatments and trials. Participants will do one in-person visit with standard questions and a clinical exam, give a blood sample and a small skin sample (a skin punch biopsy) so researchers can study genetic and other biological markers, and in some people they will also collect spinal fluid using a lumbar puncture. Adults 18 and older can join; the younger-onset group needs Parkinson's that began at age 50 or younger, the later-onset group needs Parkinson's that began after age 50, and healthy volunteers must never have had Parkinson's. People with other types of parkinsonism, autoimmune or long-term inflammatory conditions or use of long-term immune-suppressing medicines, pregnancy, or skin problems that prevent a biopsy are not eligible. **Estimated commitment:** Moderate commitment estimated from the protocol (based on: invasive procedure). This reflects time and procedures only — confirm details with the study coordinator. ## What This Actually Involves **Placebo** _(From the protocol)_: This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care. **Visits** _(From the protocol)_: Each participant has one in-person visit at the study center. > "The study duration for each participant is of one in-person visit at the study center." **Procedures** _(From the protocol)_: - Biopsy (Invasive) > "* Skin punch biopsy (3mm) for the assessment of the Alpha-Synuclein seeding amplification (SAA) Assay" - Lumbar puncture (spinal tap) (Invasive) > "\- Lumbar puncture for the collection of spinal fluid for the study of biological profiles" - Blood draw (Minimally invasive) > "* Peripheral blood sample for the study of genetic and multi-omics data" - Skin biopsy (Minimally invasive) > "* Skin punch biopsy (3mm) for the assessment of the Alpha-Synuclein seeding amplification (SAA) Assay" - Questionnaires & surveys (Non-invasive) > "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." **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## Eligibility at a Glance Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call. - **Disease stage:** Stage 1 on the Hoehn and Yahr scale - **Age when symptoms began:** Parkinson's must have started after age 50 (criteria text: "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") - **Healthy volunteers:** Also accepts people without Parkinson's (healthy volunteers) (criteria text: "CT.gov structured field: healthyVolunteers") ## Do I Likely Qualify? — Self-Check Dimensions The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed. - This trial requires Hoehn and Yahr stage 1. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL ### Full Criteria ``` 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 ``` ## Locations (1) - NYU Langone Health, New York, New York, United States _(40.7143, -74.0060)_ ## Central Contacts - Mark Belio, MD, PhD, (CONTACT), 646-501-4367, Mark.Belio@nyulangone.org - Kelly Astudillo, (CONTACT), Kelly.Astudillo@nyulangone.org ## Making Contact: How to Call This Study Site ### Who to ask for Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study. ### What to say It is fine to read this out loud, word for word: > Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07752355. It is the one about "Studying early onset biological markers". Could I speak with the study coordinator about taking part? If you are calling for a family member, use their name and mention that you help with their care. ### What they will ask you - The year of diagnosis - Current medications and their doses - Other health conditions - Any procedures already done, such as deep brain stimulation (DBS) - How far you are able to travel for study visits - Whether a care partner can come to visits with you ### What to have ready - A written list of current medications and doses - Your neurologist's name and phone number - The diagnosis date. The year is enough. - A recent visit summary from the neurologist, if you have one ### What to ask them - How many visits are there, and how long does each visit take? The listing already answers this: Each participant has one in-person visit at the study center. Ask the coordinator to confirm it still applies. - Is travel, parking, or my time reimbursed? - Is there a placebo group, and what is my chance of being in it? The listing already answers this: This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care. Ask the coordinator to confirm it still applies. - Would I need to stop or pause any of my current medications? - What happens when the study ends? Could I stay on the treatment if it helps? ### What to expect - Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal. - Many callers do not end up joining. Screening out is common and is not a judgment about you or your health. - Asking questions commits you to nothing. You can stop the process at any point. --- *Canonical: https://parkinsonspathways.com/trial/NCT07752355* *HTML version: https://parkinsonspathways.com/trial/NCT07752355* *Source data: https://clinicaltrials.gov/study/NCT07752355*