Clinical trial NCT04700722: Synuclein-One Study
Official title: Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Multiple System Atrophy
Dementia With Lewy Bodies
Pure Autonomic Failure
Keywords: Neurodegenerative Diseases
Lead sponsor: CND Life Sciences
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 428
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Primary Outcome 1
timeFrame: 2 years
measure: Primary Outcome 2
timeFrame: 2 years
measure: Primary Outcome 3
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research
state: Arizona
city: Phoenix
country: United States
facility: CND Life Sciences
state: Arizona
city: Scottsdale
country: United States
facility: Movement Disorders Center of Arizona
state: Arizona
city: Carlsbad
country: United States
facility: The Neuro Center
state: California
city: Santa Monica
country: United States
facility: Providence St. John's Health
state: California
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center, PC
state: Colorado
city: Aventura
country: United States
facility: Aventura Neurology
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: UF College of Medicine
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center SWFL
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Lahey Health
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Patchogue
country: United States
facility: SouthShore Neurologic
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence Brain & Spine Institute
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UTSouthwestern
state: Texas
city: Georgetown
country: United States
facility: Texas Movement Disorders Specialists
state: Texas
city: Kirkland
country: United States
facility: Evergreen Health
state: Washington
city: Seattle
country: United States
facility: Swedish Neuroscience Research
state: Washington
Study officials:
affiliation: CND Life Sciences: www.cndlifesciences.com
name: Todd Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.