MJFF awards grant to study skin test that detects alpha-synuclein...

CND Life Sciences has been awarded a $4.2 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) toward a study that will evaluate the use of an alpha-synuclein skin test to aid in diagnosing Parkinson’s disease and tracking its progression.

The Syn-Q clinical trial will investigate the Syn-One Test to quantify the phosphorylated form of a protein called alpha-synuclein, which typically forms clumps in people with Parkinson’s.

“This grant from MJFF will accelerate our efforts to quantify and monitor alpha-synuclein progression over time,” Todd Levine, MD, CND’s chief medical officer, said in a press release.

“Biomarkers are critical to early diagnosis and the development of effective treatments for Parkinson’s disease,” said Mark Frasier, PhD, MJFF’s chief scientist. “The Foundation supports an aggressive agenda to develop quantitative biomarkers of progression that enables research and improves clinical trials.”

Parkinson’s disease is caused by the progressive loss of dopaminergic neurons, the nerve cells that produce dopamine, a brain chemical messenger needed for muscle control. The formation of abnormal protein clumps, called Lewy bodies, is thought to contribute to neuronal damage.

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Skin test of alpha-synuclein

Phosphorylated alpha-synuclein is a main component of Lewy bodies, and contributes to nerve cell death in Parkinson’s and related synucleinopathies such as Lewy body dementia.

An early diagnosis is key for patients to access neurological care, but evidence suggests a significant proportion of Parkinson’s patients are misdiagnosed, particularly at the early stages. Also, most tests are highly invasive, including collecting cerebrospinal fluid, which surrounds the brain and spinal cord.

Syn-One uses a skin biopsy test to assess levels of phosphorylated alpha-synuclein in skin nerve fibers.

In the Synuclein-One Study (NCT04700722), sponsored by the National Institutes of Health, the test correctly identified 95% of the patients with a clinical diagnosis of synucleinopathy, reaching 92.7% for those suspected of having Parkinson’s disease.

The Syn-Q trial will further evaluate levels of phosphorylated alpha-synuclein in skin samples over time, to track its progression in people with Parkinson’s.

The trial is expected to enroll 75 Parkinson’s patients and 25 with REM Sleep Behavior Disorder, a sleep problem common in Parkinson’s patients that can be an early symptom of the disease. To ensure participants diversity, about 25 clinical centers will take part in the study.

“We believe this study will provide a foundational understanding of the natural progression of phosphorylated alpha-synuclein deposition in Parkinson’s disease patients and support the ability to recognize who responds to treatment, assess therapeutic impact, and monitor disease progression,” said Christopher Gibbons, MD, chief scientific officer at CND.

While the test is highly specific for diagnosing synucleinopathy, it doesn’t currently distinguish between diseases, according to CND, which recommends the results be used in combination with other clinical features for a more specific diagnosis.