Synuclein-One Study

Completed

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

• Registration Number: NCT04700722
• Lead Sponsor: CND Life Sciences

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.

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Primary Completion: 2022-12-14
• Study Completion: 2023-11-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (23)

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

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