Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Key facts
- Where
- Farmington Hills, Houston, Irvine, Kansas City, Los Angeles, Louisville, Memphis, Nashville, Orlando és Scottsdale, Egyesült ÁllamokSee the 11 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
Forrás: NCT07428447: ki vehet részt
Where in Egyesült Államok
- QUEST Research InstituteFarmington Hills, Egyesült ÁllamokTaking people
- Baylor College of MedicineHouston, Egyesült ÁllamokTaking people
- University of California Irvine HealthIrvine, Egyesült ÁllamokToborzás még nem indult
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokTaking people
- Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokToborzás még nem indult
- Norton HealthcareLouisville, Egyesült ÁllamokTaking people
- Veracity Neurosciences LLCMemphis, Egyesült ÁllamokTaking people
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokToborzás még nem indult
- Neurology OneOrlando, Egyesült ÁllamokTaking people
- CND Clinical Research CenterScottsdale, Egyesült ÁllamokTaking people
- Movement Disorders Center of ArizonaScottsdale, Egyesült ÁllamokTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CND Life Sciences
- Trial code
- NCT07428447
- Record updated
- 2026. november 10.
- Original 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.Read full original descriptionShow less
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
Inclusion: 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: Participant is currently receiving treatment with carbidopa-levodopa for PD; Prior to enrollment, receipt of an intracranial procedure intended to treat tremor or parkinsonism, including thalamic deep brain stimulation (DBS) implantation or focused ultrasound (FUS) thalamotomy. Other prior intracranial surgery is exclusionary only when, in the investigator's or Sponsor's Chief Medical Officer's judgment, it could materially affect motor assessments, diagnostic classification, participant safety, or interpretation of study outcomes; Clinical evidence of severe peripheral vascular disease; Clinically active coronary artery or cerebrovascular disease; Allergic reaction to local anesthesia; History of or increased risk for impaired wound healing, scarring, or keloid formation; History of other neurodegenerative disorder or evidence of neurological co-pathology; Participant is currently on anticoagulant or dual anti-platelet therapy; Under age 50, Over age 85; Alcoholism; Diagnosis of ET or ET-Plus that is clinically determined to likely be secondary to brain injury or vascular compromise; Abnormal DaTscan; 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.