Recruiting

Syn-One Test

Sponsor:

CND Life Sciences

Code:

NCT07428447

Conditions

Essential Tremor, Movement Disorders

Essential Tremor

Essential Tremor-plus

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Essential Tremor, Movement Disorders

Essential Tremor

Essential Tremor-plus

Study ID

NCT07428447

Start date

Feb 18, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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
  • 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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Essential Tremor

Those diagnosed with Essential Tremor

Essential Tremor Plus

Those diagnosed with Essential Tremor Plus

Primary outcome measure

  • 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 ]
  • Rate of Phenoconversion [ Time Frame: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24 ]

Central Contacts and Locations

Central contacts

Jeannie Director of Clinical Research

480-434-6446ClinicalResearch@cndlifesciences.com

Locations

CND Clinical Research Center

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Jeannie Director of Clinical Research

480-434-6446ClinicalResearch@cndlifesciences.com

Principal Investigator:

Padma Mahant, MD

Neurology One

Recruiting

Orlando, Florida, United States, 32825

Contacts

Jinna Santiago, RN, CRC

407-706-3060jsantiago@n1research.org

Victor Lameda, CRC

407-706-3060vlameda@n1research.org

Principal Investigator:

Ramon L Rodriguez, MD, FAAN

Norton Healthcare

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Andrea J Gambrell, RN, BSN, CCM

502-446-8544andrea.gambrell@nortonhealthcare.org

Hannah Scully, RN

502-588-0719hannah.scully@nortonhealthcare.org

Principal Investigator:

Jason Crowell, MD

Veracity Neurosciences LLC

Recruiting

Memphis, Tennessee, United States, 38157

Contacts

Hannah Touliatos

901-443-9170hannah@veracityneuroscience.com

Principal Investigator:

Mark LeDoux, MD, PhD

More Information

Sponsor

CND Life Sciences

Last update posted

Sep 18, 2026

Last verified

Aug, 2026

Keywords

  • skin biopsy
  • Syn-One

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by CND Life Sciences on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.