Actively Recruiting
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Led by CND Life Sciences · Updated on 2026-02-23
300
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
C
CND Life Sciences
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50-85 years old
- Diagnosis of Essential Tremor (ET) defined by 2018 MDS Task Force: isolated bilateral upper limb action tremor, at least 3 years' duration, with or without tremor in other locations, no other neurological signs
- Diagnosis of Essential Tremor-Plus (ET-Plus) with ET characteristics plus mild additional neurological signs such as impaired gait, questionable dystonia, memory impairment, or mild unknown neurological signs
- Willing to participate in all study procedures
- Able and willing to provide written informed consent
You will not qualify if you...
- Under age 50 or over age 85
- Severe peripheral vascular disease
- Clinically active coronary artery or cerebrovascular disease
- Currently on anticoagulant or dual anti-platelet therapy
- Alcoholism
- Allergic reaction to local anesthesia
- History or risk for impaired wound healing, scarring, or keloid formation
- ET or ET-Plus likely secondary to brain injury or vascular compromise
- History of other neurodegenerative disorders or neurological co-pathology
- Abnormal DaTscan
- Currently receiving carbidopa-levodopa treatment for Parkinson's disease
- Isolated focal tremors (head, voice)
- Task-specific tremor (e.g., primary writing tremor)
- Position-specific tremors not meeting ET diagnostic criteria
- Sudden onset and step-wise deterioration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CND Clinical Research Center
Scottsdale, Arizona, United States, 85258
Actively Recruiting
Research Team
J
Jeannie Director of Clinical Research
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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