NCT07428447

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

February 13, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

February 13, 2026

Last Update Submit

July 6, 2026

Conditions

Essential Tremor, Movement DisordersEssential TremorEssential Tremor-plus

Keywords

skin biopsySyn-One

Outcome Measures

Primary Outcomes (2)

  • Quantity of P-SYN in skin

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

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

  • Rate of Phenoconversion

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

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

Study Arms (2)

Essential Tremor

Those diagnosed with Essential Tremor

Essential Tremor Plus

Those diagnosed with Essential Tremor Plus

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CND Clinical Research Center

Scottsdale, Arizona, 85258, United States

RECRUITING

Veracity Neurosciences LLC

Memphis, Tennessee, 38157, United States

RECRUITING

MeSH Terms

Conditions

Essential TremorMovement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Central Study Contacts

Jeannie Director of Clinical Research

CONTACT

480-434-6446ClinicalResearch@cndlifesciences.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 23, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2029

Last Updated

July 8, 2026

Record last verified: 2026-07

Locations

US(2)