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
104 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
Essential tremor (ET) affects over 6 million Americans and about 5% of adults over age 60. People with ET have a significantly higher chance of developing Parkinson's disease (PD) compared to others their age, with about 1% developing PD each year. Some ET patients show Lewy body pathology after death, indicating that a portion may be in early stages of PD. Current screening tests for early PD are either not sensitive enough, costly, or invasive. This study looks at the Syn-One Test, which uses a small skin biopsy to detect phosphorylated alpha-synuclein (P-SYN), a marker linked to PD. Participants diagnosed with ET or ET-Plus will be observed to find out if they have P-SYN in their skin and to predict who may develop PD over time. The study includes adults aged 50 to 85 years and follows them from the start for up to 24 months. Participants will be divided into groups based on their diagnosis of ET or ET-Plus. During the study, researchers will measure the amount of P-SYN in skin samples at the start, at 12 months, and again at 24 months. They will also track if and when participants develop PD symptoms. Participants must complete all study procedures and give informed consent. Safety factors like wound healing and anesthesia allergies are considered to protect participants.
CONDITIONS
Brief 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 to 85 years old
- Diagnosis of Essential Tremor as defined by the 2018 MDS Task force: isolated bilateral upper limb action tremor for at least 3 years, with or without tremor in other locations, and no other neurological signs
- Diagnosis of Essential Tremor Plus as defined by the 2018 MDS Task force: ET characteristics plus additional mild neurological signs of uncertain significance
- 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 of 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 that do not meet ET diagnostic criteria
- Sudden onset and step-wise deterioration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline to Month 12
Participants undergo assessments including skin biopsy to measure phosphorylated alpha-synuclein and evaluate neurological signs.
Visits at Baseline and Month 12
Duration - Month 12 to Month 24
Participants are observed over time to monitor progression from Essential Tremor to Parkinson's Disease.
Visit at Month 24
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
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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