Synuclein-One Study

NCT ID: NCT04700722

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 428 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2023-11-08

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Parkinson's disease

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

Skin Biopsy

Intervention Type: 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.

Multiple System Atrophy

Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age.

Skin Biopsy

Intervention Type: 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

Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age.

Skin Biopsy

Intervention Type: 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.

Pure Autonomic Failure

Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age.

Skin Biopsy

Intervention Type: 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.

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.

Skin Biopsy

Intervention Type: 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.

Interventions

Skin Biopsy

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CND Life Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Levine, MD

Role: PRINCIPAL_INVESTIGATOR

CND Life Sciences: www.cndlifesciences.com

Locations

MD First Research

Chandler, Arizona, United States

CND Life Sciences

Phoenix, Arizona, United States

Movement Disorders Center of Arizona

Scottsdale, Arizona, United States

The Neuro Center

Carlsbad, California, United States

Providence St. John's Health

Santa Monica, California, United States

Rocky Mountain Movement Disorders Center, PC

Englewood, Colorado, United States

Aventura Neurology

Aventura, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

UF College of Medicine

Gainesville, Florida, United States

Parkinson's Disease Treatment Center SWFL

Port Charlotte, Florida, United States

NorthShore University Health System

Evanston, Illinois, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Lahey Health

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

NYU Medical Center

New York, New York, United States

SouthShore Neurologic

Patchogue, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Providence Brain & Spine Institute

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UTSouthwestern

Dallas, Texas, United States

Texas Movement Disorders Specialists

Georgetown, Texas, United States

Evergreen Health

Kirkland, Washington, United States

Swedish Neuroscience Research

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35272481 (View on PubMed)

Other Identifiers

CND-100

Identifier Type: -

Identifier Source: org_study_id