Parkinson DiseaseNCT04700722
Synuclein-One Study
An observational study of Parkinson Disease and Multiple System Atrophy, run by CND Life Sciences at 23 sites in United States.
Trial summary
The Synuclein-One Study will be evaluating α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies
- What is being tested?
- Skin Biopsy
- How many people
- 428 participants
- Where
- 23 sitesUnited States
- Study dates
- 4 Jan 2021to 8 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 99 years
- All sexes
- Adult, Older adult
Study population: Eligible men and women, age 40-99 years, will undergo a screening evaluation that includes a thorough medical history, physical and neurologic exam, orthostatic vitals, questionnaires and skin biopsy completed in one visit.
Who may be able to join
- Male and female between 40-99 years of age
- Prior clinical diagnosis of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure
- Health Subjects, no history of clinical or symptoms suggestive with synucleinopathy
Who cannot join
- Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, vascular claudication)
- Clinically active coronary artery or cerebrovascular disease
- Current smoker or alcoholism
- History of allergic reaction to local anesthesia for skin biopsies
- Use of blood thinners (aspirin or Plavix alone is allowed)
- Significantly impaired wound healing or history of scarring or keloid formation
- Healthy individuals or individuals with synucleinopathy is disease may be explained by other causes: recent history of encephalitis, Cortical dementia of Alzheimer's type, Whipple's disease, toxin exposure, repeated head injury and stepwise disease progression suggestive of vascular etiology
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Aventura Neurology
Aventura, Florida, 33180
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Lahey Health
Boston, Massachusetts, 02215
The Neuro Center
Carlsbad, California, 92011
MD First Research
Chandler, Arizona, 85286
UTSouthwestern
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, 80113
NorthShore University Health System
Evanston, Illinois, 60201
UF College of Medicine
Gainesville, Florida, 32608
Texas Movement Disorders Specialists
Georgetown, Texas, 78628
Evergreen Health
Kirkland, Washington, 98034
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Medical Center
New York, New York, 10016
SouthShore Neurologic
Patchogue, New York, 11772
CND Life Sciences
Phoenix, Arizona, 85018
Parkinson's Disease Treatment Center SWFL
Port Charlotte, Florida, 33980
Providence Brain & Spine Institute
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
Providence St. John's Health
Santa Monica, California, 90404
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
Swedish Neuroscience Research
Seattle, Washington, 98122
About this study
Official title: Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
The Synuclein-One Study will be evaluating α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.
Read the detailed description
Phosphorylated α-synuclein pathology in the diagnosis of synucleinopathies through qualitative and quantitative measurements of cutaneous phosphorylated α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. An effective tissue biomarker will provide an accurate diagnosis of α-synuclein in clinical practice, will differentiate between synucleinopathies, enable assessment of target engagement in the development of disease modifying and neuroprotective therapies and accelerate the development of neuroprotective and disease modifying therapies.
- Conditions
- Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies, Pure Autonomic Failure
- Being tested
- Skin Biopsy
- Keywords
- Neurodegenerative Diseases
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Lewy Body Disease, Pure Autonomic Failure, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin BiopsyDiagnostic test
Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age. Receives: Diagnostic Test: Skin Biopsy | |
| Multiple System Atrophy | Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age. Receives: Diagnostic Test: Skin Biopsy | |
| Dementia with Lewy bodies | Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age. Receives: Diagnostic Test: Skin Biopsy | |
| Pure Autonomic Failure | Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age. Receives: Diagnostic Test: Skin Biopsy | |
| Healthy Controls | No history of clinical or symptoms suggestive of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure between 40-99 years of age. Receives: Diagnostic Test: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1
To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
Measured: 2 years
Primary Outcome 2
To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
Measured: 2 years
Primary Outcome 3
To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start4 Jan 2021
- Primary completion14 Dec 2022
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Cross-sectional
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- CND Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Levine, MD, Principal investigator, CND Life Sciences: www.cndlifesciences.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700722
- Sponsor's protocol ID
- CND-100
- Status last verified
- Dec 2023
- First submitted
- 6 Jan 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with researchers that are involved in the study.
Publications
Gibbons CH, Levine T, Adler CH, Bellaire B, Wang N, Agarwal P, Aldridge GM, Barboi A, Claassen D, Evidente VGH, Galasko D, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis MG, Reynolds A, Sahagian GA, Saint-Hilaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Millar Vernetti P, Yerstein O, Freeman R. Cutaneous Phosphorylated Alpha-Synuclein in Lewy Body Dementia. Ann Clin Transl Neurol. 2026 May;13(5):1041-1051. doi: 10.1002/acn3.70291. Epub 2025 Dec 25.
PubMed 41449577Gibbons CH, Freeman R, Bellaire B, Adler CH, Moore D, Levine T. Synuclein-One study: skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Biomark Med. 2022 May;16(7):499-509. doi: 10.2217/bmm-2021-0646. Epub 2022 Mar 11.
PubMed 35272481
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
- ClinicalTrials.gov ID
- NCT04700722
- Acronym / sponsor ID
- CND-100
- Conditions
- Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies, Pure Autonomic Failure
- Keywords
- Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- CND Life SciencesUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 8 Jan 2021 (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.
The Synuclein-One Study will be evaluating α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.
Detailed description
Phosphorylated α-synuclein pathology in the diagnosis of synucleinopathies through qualitative and quantitative measurements of cutaneous phosphorylated α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. An effective tissue biomarker will provide an accurate diagnosis of α-synuclein in clinical practice, will differentiate between synucleinopathies, enable assessment of target engagement in the development of disease modifying and neuroprotective therapies and accelerate the development of neuroprotective and disease modifying therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Diagnostic Test: Skin BiopsyLooking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age. |
| Multiple System Atrophy | – | Diagnostic Test: Skin BiopsyLooking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age. |
| Dementia with Lewy bodies | – | Diagnostic Test: Skin BiopsyLooking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age. |
| Pure Autonomic Failure | – | Diagnostic Test: Skin BiopsyLooking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age. |
| Healthy Controls | – | Diagnostic Test: Skin BiopsyNo history of clinical or symptoms suggestive of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure between 40-99 years of age. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible men and women, age 40-99 years, will undergo a screening evaluation that includes a thorough medical history, physical and neurologic exam, orthostatic vitals, questionnaires and skin biopsy completed in one visit.
Key inclusion criteria (3 listed)
- Male and female between 40-99 years of age
- Prior clinical diagnosis of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure
- Health Subjects, no history of clinical or symptoms suggestive with synucleinopathy
Key exclusion criteria (7 listed)
- Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, vascular claudication)
- Clinically active coronary artery or cerebrovascular disease
- Current smoker or alcoholism
- History of allergic reaction to local anesthesia for skin biopsies
- Use of blood thinners (aspirin or Plavix alone is allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin BiopsyTest accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies. | Diagnostic test | Dementia with Lewy bodies, Healthy Controls, Multiple System Atrophy, Parkinson's disease, Pure Autonomic Failure |
Primary outcome
Primary Outcome 1
Time frame: 2 years
To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 2
Time frame: 2 years
To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 3
Time frame: 2 years
To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 41449577Gibbons CH, Levine T, Adler CH, Bellaire B, Wang N, Agarwal P, Aldridge GM, Barboi A, Claassen D, Evidente VGH, Galasko D, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis MG, Reynolds A, Sahagian GA, Saint-Hilaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Millar Vernetti P, Yerstein O, Freeman R. Cutaneous Phosphorylated Alpha-Synuclein in Lewy Body Dementia. Ann Clin Transl Neurol. 2026 May;13(5):1041-1051. doi: 10.1002/acn3.70291. Epub 2025 Dec 25.
- Derived from this study: PubMed 35272481Gibbons CH, Freeman R, Bellaire B, Adler CH, Moore D, Levine T. Synuclein-One study: skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Biomark Med. 2022 May;16(7):499-509. doi: 10.2217/bmm-2021-0646. Epub 2022 Mar 11.
- Individual participant dataSharing planned: No. IPD will be shared with researchers that are involved in the study.
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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. This study is not recruiting at the moment.
Todd Levine, MD principal investigator
CND Life Sciences: www.cndlifesciences.com
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple System Atrophy, run by CND Life Sciences at 23 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1 (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700722, which also lists 2 linked publications.
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 3 Jan 2024.