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RecruitingNCT07428447Syn-TUpdated Sep 18, 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 4 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by CND Life Sciences · Observational

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

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.

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 informed consent

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-platelet 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.
04

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

05

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

06

Study locations

4 of 4 sites recruiting
  • CND Clinical Research Center
    Scottsdale, Arizona 85258, United States
    Recruiting
  • Neurology One
    Orlando, Florida 32825, United States
    Recruiting
  • Norton Healthcare
    Louisville, Kentucky 40202, United States
    Recruiting
  • Veracity Neurosciences LLC
    Memphis, Tennessee 38157, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07428447
Lead sponsor
CND Life Sciences
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Feb 18, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2029 (estimated)
Last update
Sep 18, 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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