NCT07428447 · CND Life Sciences
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
(Syn-T)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether 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
- 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
Where
- Scottsdale, Arizona
- Memphis, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations