CND Life Sciences to Present Updates from Three Clinical Trials Involving Their Skin Biopsy Diagnostic Tool for Dementia and Other Related Disorders at the American Academy of Neurology 2025 Annual Meeting

Two studies track changes in cutaneous phosphorylated alpha-synuclein (P-SYN) in patients with dementia with Lewy bodies (DLB); the other determines the optimal number of skin biopsies necessary for accurate detection of P-SYN

SCOTTSDALE, Ariz., March 27, 2025 /PRNewswire/ -- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced that three abstracts related to changes in cutaneous phosphorylated alpha-synuclein (P-SYN) in patients with dementia with Lewy bodies (DLB) and other related disorders will be presented at the American Academy of Neurology 2025 Annual Meeting (AAN) from April 5-9 at the San Diego Convention Center.

Christopher Gibbons, MD, FAAN, chief scientific officer and co-founder of CND Life Sciences and professor of Neurology at Harvard Medical School, served as the lead author on two studies, both designed to track changes over time in cutaneous P-SYN in patients with DLB using skin biopsies. At the AAN, Dr. Gibbons will present unblinded baseline data quantifying the deposition of P-SYN and blood P-Tau 217 in patients with suspected DLB and Alzheimer's disease at the mild cognitive impairment stage. He will also report on another study demonstrating that quantitative measures of cutaneous deposition suggest an annual increase in P-SYN deposition of 52% in patients with DLB.

"This research further highlights that skin biopsies offer a simple outpatient test to help clinicians detect and quantify changes in P-SYN in patients with DLB," said Dr. Gibbons. "Additionally, they can serve as a tool for pharmaceutical trials to ensure the right patients are enrolled and to provide the ability to measure change over time, aiding in the development of investigational therapies that seek to alter P-SYN deposition or aggregation."

Additional research found that limiting skin biopsy protocols to fewer than three biopsies results in a clinically significant percentage of false negative tests that increase as diagnostic certainty decreases. Furthermore, the diagnostic discrimination of synuclein subtyping provided by deposition pattern and distribution is lost with fewer than three biopsies.

"The Syn-One Test is a reliable, evidence-based test designed to help clinicians accurately diagnose suspected synucleinopathies," said Todd Levine, MD, chief medical officer at CND Life Sciences and lead author of the study on the diagnostic performance of the Syn-One Test. "Making an accurate diagnosis is critical for optimal patient care, and the Syn-One Test provides a minimally-invasive opportunity to obtain greater clarity in complicated diagnostic cases."

Details on relevant presentations are as follows:

About CND Life Sciences
CND Life Sciences supports the care of patients facing the potential diagnosis of neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND developed the Syn-One Test to help clinicians diagnose Parkinson's disease, dementia with Lewy bodies, and related disorders known as synucleinopathies. Syn-One uses proprietary immunofluorescence techniques to detect, visualize, and quantify phosphorylated alpha-synuclein in cutaneous nerves. Results of a recent prospective, multicenter NIH-sponsored study of the Syn-One Test were published in the Journal of the American Medical Association (JAMA) demonstrating >95% sensitivity in patients with a clinically determined synucleinopathy.¹ The test analyzes three small skin biopsy samples collected in a clinician's office through an in-office patient procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic markers. Approximately 2,500 neurologists and other clinicians in 49 states have used the Syn-One Test to support their diagnostic evaluation of patients. The Company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting studies assessing the test's ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn.

¹ Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated α-synuclein in patients with synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792.

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SOURCE CND Life Sciences