Synuclein-One Study

Parkinson Disease Clinical Trial

Official title:

Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700722
• Other study ID #: CND-100
• Status: Completed
• Start date: January 4, 2021
• Est. completion date: November 8, 2023

Study information

• Verified date: December 2023
• Source: CND Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: November 8, 2023
• Est. primary completion date: December 14, 2022
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia With Lewy Bodies
• Lewy Body Disease
• Multiple System Atrophy
• Parkinson Disease
• Pure Autonomic Failure
• Shy-Drager Syndrome

Intervention

Diagnostic Test:
• Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated a-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated a-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated a-synuclein with skin biopsies.

Locations

Country	Name	City	State
United States	Aventura Neurology	Aventura	Florida
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Beth Israel Lahey Health	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	The Neuro Center	Carlsbad	California
United States	MD First Research	Chandler	Arizona
United States	UTSouthwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Rocky Mountain Movement Disorders Center, PC	Englewood	Colorado
United States	NorthShore University Health System	Evanston	Illinois
United States	UF College of Medicine	Gainesville	Florida
United States	Texas Movement Disorders Specialists	Georgetown	Texas
United States	Evergreen Health	Kirkland	Washington
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	NYU Medical Center	New York	New York
United States	SouthShore Neurologic	Patchogue	New York
United States	CND Life Sciences	Phoenix	Arizona
United States	Parkinson's Disease Treatment Center SWFL	Port Charlotte	Florida
United States	Providence Brain & Spine Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Providence St. John's Health	Santa Monica	California
United States	Movement Disorders Center of Arizona	Scottsdale	Arizona
United States	Swedish Neuroscience Research	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
CND Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome 1	To define test accuracy and precision of skin biopsy detection of phosphorylated a-synuclein.	2 years
Primary	Primary Outcome 2	To define sensitivity and specificity of skin biopsy detection of phosphorylated a-synuclein.	2 years
Primary	Primary Outcome 3	To differentiate between the synucleinopathies by quantitative measurement of phosphorylated a-synuclein with skin biopsies.	2 years