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

Study acronym: Syn-T
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 4 → 8 locations
  2. Eligibility criteria expanded, about 79 words
  3. Study sites: 2 to 4v4
  4. Site contacts updated at 1 of 2 sitesv3
  5. Study sites: 1 to 2v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07428447
Lead Sponsor CND Life Sciences
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Essential Tremor, Movement Disorders, Essential Tremor, Essential Tremor-plus
Related terms Essential Tremor, Movement Disorders
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov