Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07428447

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CND Clinical Research Center, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. Quantity of P-SYN in skin

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

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

  2. Rate of Phenoconversion

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jeannie Director of Clinical Research

CONTACT

[email protected]

480-434-6446 ext. 371

Sponsors and collaborators

Lead sponsor

CND Life Sciences

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: Syn-T

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Feb 23, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.