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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

50 years - 85 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

300 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 population

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (11)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

11 locations

Study team and timeline

Lead sponsor

CND Life Sciences

Study start

Feb 18, 2026 Actual

Primary completion

2027-02 Estimated

Study completion

2029-02 Estimated

First posted

Feb 23, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts