Synuclein-One Study

Sponsor

CND Life Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04700722

Collaborator

(none)

500

Enrollment

Locations

22.9

Anticipated Duration (Months)

21.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Multiple System Atrophy Dementia With Lewy Bodies Pure Autonomic Failure	Diagnostic Test: Skin Biopsy

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

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy

Actual Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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.	Diagnostic Test: 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.
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 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.	Diagnostic Test: 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.
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 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.

Outcome Measures

Primary Outcome Measures

Primary Outcome 1 [2 years]
To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 2 [2 years]
To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 3 [2 years]
To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 99 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD First Research	Chandler	Arizona	United States	85286
2	CND Life Sciences	Phoenix	Arizona	United States	85018
3	Movement Disorders Center of Arizona	Scottsdale	Arizona	United States	85258
4	The Neuro Center	Carlsbad	California	United States	92011
5	Providence St. John's Health	Santa Monica	California	United States	90404
6	Rocky Mountain Movement Disorders Center, PC	Englewood	Colorado	United States	80113
7	Aventura Neurology	Aventura	Florida	United States	33180
8	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	United States	33486
9	UF College of Medicine	Gainesville	Florida	United States	32608
10	Parkinson's Disease Treatment Center SWFL	Port Charlotte	Florida	United States	33980
11	NorthShore University Health System	Evanston	Illinois	United States	60201
12	Boston Medical Center	Boston	Massachusetts	United States	02118
13	Beth Israel Lahey Health	Boston	Massachusetts	United States	02215
14	Mayo Clinic	Rochester	Minnesota	United States	55905
15	NYU Medical Center	New York	New York	United States	10016
16	SouthShore Neurologic	Patchogue	New York	United States	11772
17	Duke University Medical Center	Durham	North Carolina	United States	27710
18	Providence Brain & Spine Institute	Portland	Oregon	United States	97225
19	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
20	UTSouthwestern	Dallas	Texas	United States	75390
21	Texas Movement Disorders Specialists	Georgetown	Texas	United States	78628
22	Evergreen Health	Kirkland	Washington	United States	98034
23	Swedish Neuroscience Research	Seattle	Washington	United States	98122