ClinicalTrials.gg
RecruitingNCT07428447Syn-TUpdated Nov 10, 2026

Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease

An observational study in Essential Tremor, Movement Disorders, Essential Tremor and Essential Tremor-plus, sponsored by CND Life Sciences. Recruiting at 11 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by CND Life Sciences · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Updated Nov 10, 2026Site recruiting status changed7 sites addedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
50 Years to 85 Years
Sex
All
01

Study summary

Background and Rationale Essential tremor (ET) affects over 6 million Americans and approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk of developing Parkinson's disease (PD) compared to age-matched populations, with approximately 1% converting to PD annually. Post-mortem studies reveal Lewy body pathology in some ET patients, suggesting a subset may have prodromal PD. Current diagnostic tools (DaTscan, SYNTap) are either insufficiently sensitive for early disease, too expensive, or too invasive for routine screening. The Syn-One Test offers a minimally invasive approach to detect phosphorylated α-synuclein (P-SYN) pathology in skin biopsies.

Primary Objectives

  1. Identify which ET patients have P-SYN pathology indicative of prodromal PD
  2. Predict which patients are most likely to phenoconvert to PD
02

Conditions studied

  • Essential Tremor, Movement Disorders
  • Essential Tremor
  • Essential Tremor-plus

Keywords

  • skin biopsy
  • Syn-One
03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 300 is above the median of 89 across 70 observational studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

CND Life Sciences is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be enrolled from up to 18 sites across the US from academic institutions and private clinics.

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

  • Age 50-85 years old
  • Diagnosis of ET as defined by the 2018 MDS Task force paper "1) isolated tremor syndrome of bilateral upper limb action tremor 2) at least 3 years' duration 3) with or without tremor in other locations (e.g., head, voice, or lower limbs) 4) absence of other neurological signs, such as dystonia, ataxia, or parkinsonism." OR
  • Diagnosis of ET-Plus as stated by the 2018 MDS Task force paper, "Tremor with the characteristics of ET and additional neurological signs of uncertain significance such as impaired tandem gait, questionable dystonic posturing, memory impairment, or other mild neurologic signs of unknown significance that do not suffice to make an additional syndrome classification or diagnosis. ET with tremor at rest should be classified here."
  • Willing to participate in all study procedures
  • Able and willing to provide written

Exclusion criteria

Exclusion Criteria:

  • Under age 50, Over age 85
  • Clinical evidence of severe peripheral vascular disease
  • Clinically active coronary artery or cerebrovascular disease
  • Participant is currently on anticoagulant or dual anti- therapy
  • Alcoholism
  • Allergic reaction to local anesthesia
  • History of or increased risk for impaired wound healing, scarring, or keloid formation
  • Diagnosis of ET or ET-Plus that is clinically determined to likely be secondary to brain injury or vascular compromise
  • History of other neurodegenerative disorder or evidence of neurological co-pathology
  • Abnormal DaTscan
  • Participant is currently receiving treatment with carbidopa-levodopa for PD
  • Isolated focal tremors (head, voice)
  • Task-specific tremor (e.g., primary writing tremor)
  • Position-specific tremors that does not otherwise meet clinical diagnostic criteria for ET
  • Sudden onset and step-wise deterioration
  • Prior to enrollment, receipt of an intracranial procedure intended to treat tremor or parkinsonism, including thalamic deep brain stimulation (DBS) implantation or focused ultrasound (FUS) thalamotomy. Other prior intracranial surgery is exclusionary only when, in the investigator's or Sponsor's Chief Medical Officer's judgment, it could materially affect motor assessments, diagnostic classification, participant safety, or interpretation of study outcomes.
Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

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

Groups and cohorts

  • Essential Tremor

    Those diagnosed with Essential Tremor

  • Essential Tremor Plus

    Those diagnosed with Essential Tremor Plus

06

What researchers measure

Primary outcomes

  1. Quantity of P-SYN in skin

    Quantity of P-SYN in biopsies as a biomarker for disease progression

    Time frame: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24

  2. Rate of Phenoconversion

    Rate of phenoconversion from Essential Tremor to Parkinson's Disease over 24 months

    Time frame: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24

07

Study locations

8 of 11 sites recruiting
08

Timeline

4 registry updates 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 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.

Of 26 observational studies under Essential Tremor, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25. This study's planned 12 months is below that.

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

Registered
Feb 13, 2026
First posted
Feb 23, 2026
StartActual
Feb 18, 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2029
Last update
Nov 10, 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.
Sites
7 sites added. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Quest Research Institute · Farmington Hills, United StatesNot yet recruiting→Recruiting
  • University of Kansas Medical Center · Kansas City, United StatesNot yet recruiting→Recruiting
Show 7 added (7 United States)
  • Movement Disorders Center of Arizona · Scottsdale, United States
  • University of Kansas Medical Center · Kansas City, United States
  • Quest Research Institute · Farmington Hills, United States
  • Vanderbilt University Medical Center · Nashville, United States
  • University of California Irvine Health · Irvine, United States
  • Cedars-Sinai Medical Center · Los Angeles, United States
  • Baylor College of Medicine · Houston, United States
across 4 updates, Oct 13, 2026 – Nov 10, 2026
Show all 4 updates
  1. Nov 10, 2026
    University of Kansas Medical Center is now Recruiting
  2. Nov 4, 2026
    3 sites added
    Show 3 added (3 United States)
    • University of California Irvine Health · Irvine, United States
    • Cedars-Sinai Medical Center · Los Angeles, United States
    • Baylor College of Medicine · Houston, United States
    + 1 other change: verification date
  3. Oct 22, 2026
    Quest Research Institute is now Recruiting
  4. Oct 13, 2026
    4 sites added
    Show 4 added (4 United States)
    • Movement Disorders Center of Arizona · Scottsdale, United States
    • University of Kansas Medical Center · Kansas City, United States
    • Quest Research Institute · Farmington Hills, United States
    • Vanderbilt University Medical Center · Nashville, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07428447
Lead sponsor
CND Life Sciences
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Feb 18, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Jeannie Director of Clinical Research
Contact
ClinicalResearch@cndlifesciences.com
480-434-6446 ext. 371

Oversight

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

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