NIH funds study to predict Parkinson’s risk with skin test
CND Life Sciences gets $3M to study link between disease, essential tremor
CND Life Sciences has been awarded a $3 million grant from the U.S. National Institutes of Health (NIH) to evaluate whether its skin test can predict the risk of Parkinson’s disease in people with essential tremor.
The three-year Small Business Innovation Research grant will support a study aimed at determining whether the Syn-One test shows if people with essential tremor have the phosphorylated form of alpha-synuclein, a hallmark of Parkinson’s, and whether it’s associated with the development of the disease.
The company expects the study to enroll 300 participants at 15 participating sites across the U.S., with recruitment beginning in December.
“The risk of developing [Parkinson’s disease] can be significantly higher in people with [essential tremor] than in the general population,” Todd Levine, MD, chief medical officer and co-founder of CND, said in a company press release. “Patients and physicians want a better understanding as to the cause of the tremor, and results from this study may bring the clarity they need.”
Parkinson’s and essential tremor share common symptoms, notably tremor. While tremors in Parkinson’s usually occur when the person is not intentionally moving, essential tremor is marked by limb tremors during movement. Evidence suggests that people with essential tremor may have a higher risk of developing Parkinson’s than the general population.
Proving a link
The Syn-One test is designed to detect and visualize phosphorylated alpha-synuclein in skin nerve fibers. It is used to help diagnose synucleopathies, conditions thought to be driven by the buildup of the protein alpha-synuclein in nerve cells. These include Parkinson’s and Lewy body dementia.
The test is minimally invasive and involves the in-office collection of three punch skin biopsies, which are performed using a circular tool to remove a portion of tissue containing all skin layers. Researchers then analyze skin nerve fibers for clumps of alpha-synuclein.
“Using this technology, we aim to prove that individuals with [essential tremor] who have positive Syn-One Test results are significantly more likely to develop [Parkinson’s disease], said Christopher Gibbons, MD, CND’s co-founder and chief scientific officer. “Additionally, we would like to demonstrate that the rate of pathological alpha-synuclein accumulation correlates with progression to [Parkinson’s]. Doing so will provide physicians with valuable insight into how the disease progresses and give them, and their patients, the necessary assurance to guide their recommended treatment plan.”
Gibbons, who is also a professor at Harvard Medical School, is the study’s principal investigator.
The Synuclein-One Study (NCT04700722), sponsored by the NIH, showed the test could correctly identify 95.5% of patients with a clinical diagnosis of synucleinopathy, and 92.7% of those suspected of having Parkinson’s disease.
The test recently received U.S. Food and Drug Administration (FDA) breakthrough device designation to aid in the diagnosis of synucleinopathies in people aged 40 and older. The designation aims to accelerate the development and review of medical devices that may provide more effective treatment or diagnostic for life-threatening or irreversibly debilitating diseases.
The company was previously awarded a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to evaluate the use of Syn-One for helping diagnose Parkinson’s and track its progression.
About the Author
