Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
NCT07428447 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2026-02-23
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
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH -
CND Life Sciences
lead OTHER
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-18
- Primary Completion
- 2027-02-28
- Completion
- 2029-02-28
Countries
- United States
Study Locations
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