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

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

50 años - 85 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

300 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• 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 Criteria:

• Under age 50, Over age 85
• Clinical evidence of severe peripheral vascular disease
• Clinically active coronary artery or cerebrovascular disease
• Participant is currently on anticoagulant or dual anti-platelet therapy
• Alcoholism
• Allergic reaction to local anesthesia
• History of or increased risk for impaired wound healing, scarring, or keloid formation
• Diagnosis of ET or ET-Plus that is clinically determined to likely be secondary to brain injury or vascular compromise
• History of other neurodegenerative disorder or evidence of neurological co-pathology
• Abnormal DaTscan
• Participant is currently receiving treatment with carbidopa-levodopa for PD
• 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
• 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.

Población del estudio

Subjects will be enrolled from up to 18 sites across the US from academic institutions and private clinics.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (11)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

11 centros

Equipo y fechas

Patrocinador principal

CND Life Sciences

Inicio del estudio

18 feb 2026 Real

Finalización primaria

2027-02 Estimado

Finalización del estudio

2029-02 Estimado

Primera publicación

23 feb 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio