Synuclein-One study: skin biopsy detection of phosphorylated α-synuclein for diagnosis of synucleinopathies

Author:

Gibbons Christopher H1ORCID,Freeman Roy1,Bellaire Bailey2,Adler Charles H3,Moore Dan4,Levine Todd5

Affiliation:

1. Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02446, USA

2. CND Life Sciences, Phoenix, AZ 85018, USA

3. Department of Neurology, Mayo Clinic College of Medicine, Mayo Clinic Arizona, Scottsdale, AZ 85259, USA

4. Calico Computing, Livermore, CA 94550, USA

5. Department of Neurology, Honorhealth, Phoenix, AZ 85251, USA

Abstract

Finding an easily accessible and reliable tool to diagnose the diseases collectively defined as ‘synucleinopathies’ is an urgent, unmet priority. The synucleinopathies include Parkinson's disease, multiple system atrophy, pure autonomic failure and dementia with Lewy bodies. There are millions of people who have a diagnosis of a synucleinopathy, with more diagnosed every year. With accessibility, ease of implementation, consistently high sensitivity (>80%) and specificity approaching 100%, skin biopsy has great potential as the clinical test of choice for the diagnosis of synucleinopathies. The large, multi-center Synuclein-One study will determine the sensitivity, specificity, accuracy and precision of α-synuclein detection within punch skin biopsies in patients with clinically established synucleinopathies using standardized, robust methods suitable for large-scale analysis. Clinical Trial Registration: NCT04700722  ( ClinicalTrials.gov )

Funder

National Institute of Neurological Disorders and Stroke

Publisher

Future Medicine Ltd

Subject

Biochemistry (medical),Clinical Biochemistry,Drug Discovery

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