NCT04700722

Synuclein-One Study

Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 428 (actual)
• Sponsor: CND Life Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 99 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-04
• Primary completion: 2022-12-14
• Completion: 2023-11-08
• First posted: 2021-01-08
• Last updated: 2024-01-03

Locations

23 sites across 1 country: United States