Essential Tremor, Movement DisordersSyn-TNCT07428447
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
An observational study of Essential Tremor, Movement Disorders and Essential Tremor, run by CND Life Sciences at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Essential Tremor, Movement Disorders, Essential Tremor, Essential Tremor-plus
- How many people
- 300 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 Feb 2026to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled from up to 18 sites across the US from academic institutions and private clinics.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jeannie Director of Clinical Research contact
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Denise Morgott, 248-957-8940, denise.morgott@questri.com
Aaron Ellenbogen, DO
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Haneyeh Primary Research Coordinator, 713-798-5120, haneyeh.amidi@bcm.edu
Rory Research Manager, 713-798-5989, Rory.Mahabir@bcm.edu
- Not yet recruiting
University of California Irvine Health
Irvine, California, 92617
Shivani Venkateswaran, shivanv1@uci.edu
Ann Ly, MD
- Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kim Lee, Clinical Research Coordinator, 913-588-0013, klee9@kumc.edu
Angela Richmond, MD
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Michele Lima Gregorio, PhD, 424-315-0021, michele.gregorio@cshs.org
Anne Tran, 310-423-1697, anne.tran@cshs.org
- Recruiting
Norton Healthcare
Louisville, Kentucky, 40202
Andrea J Gambrell, RN, BSN, CCM, 502-446-8544, andrea.gambrell@nortonhealthcare.org
Hannah Scully, RN, 502-588-0719, hannah.scully@nortonhealthcare.org
- Recruiting
Veracity Neurosciences LLC
Memphis, Tennessee, 38157
Hannah Touliatos, 901-443-9170, hannah@veracityneuroscience.com
Mark LeDoux, MD, PhD
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jackie Harris, RMA, CTRC IV, 615-936-3833, jacqueline.c.harris@vumc.org
Keimora Wright, CTRC II, 615-322-0530, keimora.wright@vumc.org
- Recruiting
Neurology One
Orlando, Florida, 32825
Jinna Santiago, RN, CRC, 407-706-3060 ext. 110, jsantiago@n1research.org
Victor Lameda, CRC, 407-706-3060 ext. 109, vlameda@n1research.org
- Recruiting
CND Clinical Research Center
Scottsdale, Arizona, 85258
Jeannie Director of Clinical Research, 480-434-6446 ext. 371, ClinicalResearch@cndlifesciences.com
Padma Mahant, MD
- Recruiting
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
Danica Evidente, 480-526-5441, danica@movementdisorders.us
Virgilio Gerald H Evidente, MD
About this study
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
- Identify which ET patients have P-SYN pathology indicative of prodromal PD
- Predict which patients are most likely to phenoconvert to PD
- Keywords
- skin biopsy, Syn-One
- Medical subject headings
- Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Essential Tremor | Those diagnosed with Essential Tremor | |
| Essential Tremor Plus | Those diagnosed with Essential Tremor Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of P-SYN in skin
Quantity of P-SYN in biopsies as a biomarker for disease progression
Measured: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24
Rate of Phenoconversion
Rate of phenoconversion from Essential Tremor to Parkinson's Disease over 24 months
Measured: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start18 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Tremor, Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CND Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428447
- Sponsor's protocol ID
- CND-106
- Other IDs
- R44NS143486-01
- Acronym
- Syn-T
- Status last verified
- Nov 2026
- First submitted
- 13 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07428447
- Acronym / sponsor ID
- Syn-T / CND-106
- Keywords
- skin biopsy, Syn-One
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CND Life SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Identify which ET patients have P-SYN pathology indicative of prodromal PD
- Predict which patients are most likely to phenoconvert to PD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential Tremor | – | –Those diagnosed with Essential Tremor |
| Essential Tremor Plus | – | –Those diagnosed with Essential Tremor Plus |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled from up to 18 sites across the US from academic institutions and private clinics.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantity of P-SYN in skin
Time frame: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24
Quantity of P-SYN in biopsies as a biomarker for disease progression
Rate of Phenoconversion
Time frame: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24
Rate of phenoconversion from Essential Tremor to Parkinson's Disease over 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeannie Director of Clinical Research contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, Movement Disorders and Essential Tremor, run by CND Life Sciences at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeannie Director of Clinical Research (480-434-6446 ext. 371, ClinicalResearch@cndlifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of P-SYN in skin (time frame: From enrollment to completion of study participation from Baseline to Month 12 and then to Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.