Synuclein-One Study

NCT04700722 | Completed

• 1 other identifier: CND-100
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Parkinson Disease; Multiple System Atrophy; Dementia With Lewy Bodies; Pure Autonomic Failure

Keywords

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (3)

• Primary Outcome 1

  To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.

  2 years

• Primary Outcome 2

  To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.

  2 years

• Primary Outcome 3

  To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.

  2 years

Study Arms (5)

Parkinson's disease

Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age.

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.

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.

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.

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.

Diagnostic Test: Skin Biopsy

Interventions

Skin Biopsy DIAGNOSTIC_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.

Dementia with Lewy bodies; Healthy Controls; Multiple System Atrophy; Parkinson's disease; Pure Autonomic Failure

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CND Life Sciences: lead

Study Sites (23)

MD First Research

Chandler, Arizona, 85286, United States

Location

CND Life Sciences

Phoenix, Arizona, 85018, United States

Location

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

The Neuro Center

Carlsbad, California, 92011, United States

Location

Providence St. John's Health

Santa Monica, California, 90404, United States

Location

Rocky Mountain Movement Disorders Center, PC

Englewood, Colorado, 80113, United States

Location

Aventura Neurology

Aventura, Florida, 33180, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

UF College of Medicine

Gainesville, Florida, 32608, United States

Location

Parkinson's Disease Treatment Center SWFL

Port Charlotte, Florida, 33980, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Lahey Health

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

SouthShore Neurologic

Patchogue, New York, 11772, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Providence Brain & Spine Institute

Portland, Oregon, 97225, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UTSouthwestern

Dallas, Texas, 75390, United States

Location

Texas Movement Disorders Specialists

Georgetown, Texas, 78628, United States

Location

Evergreen Health

Kirkland, Washington, 98034, United States

Location

Swedish Neuroscience Research

Seattle, Washington, 98122, United States

Location

Related Publications (2)

• 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. 2025 Dec 25. doi: 10.1002/acn3.70291. Online ahead of print.

  PMID: 41449577 DERIVED

• Gibbons 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.

  PMID: 35272481 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin Biopsy

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Lewy Body Disease; Pure Autonomic Failure; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Primary Dysautonomias; Autonomic Nervous System Diseases; Dementia; Neurocognitive Disorders; Mental Disorders

Study Officials

• Todd Levine, MD

  CND Life Sciences: www.cndlifesciences.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: January 4, 2021
• Primary Completion: December 14, 2022
• Study Completion: November 8, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)