CND Life Sciences Secures NIH Funding for Parkinson's Disease Study
The grant will support a comprehensive, three-year research project carried out in tandem with prominent medical institutions across the nation.
SCOTTSDALE, Ariz. — CND Life Sciences (CND), a pioneering company in the medical technology sector, has announced an exciting new collaboration backed by a $3 million grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program. This funding will facilitate critical research to investigate whether the presence of phosphorylated alpha-synuclein (P-SYN) in patients who experience essential tremor (ET) indicates a higher likelihood of developing Parkinson's disease (PD).
The study, which is anticipated to yield significant insights, will leverage CND's innovative Syn-One Test as a predictive tool to determine which patients may be more susceptible to PD. The findings from this endeavor, referred to as the "Syn-T Study," are poised to have meaningful implications for the future treatment and management of ET patients.
The Significance of the Syn-T Study
"This is our fourth NIH-SBIR grant over the past five years, which serves as a strong validation of our scientific foundation and our capability to translate crucial neurodiagnostic advancements from theory into practice," stated Todd Levine, MD, chief medical officer and co-founder of CND. "The Syn-T Study is particularly vital within the neurodegeneration domain and for us at CND. With approximately seven million individuals in the U.S. living with essential tremor, the probability of developing Parkinson's disease is significantly amplified in these patients compared to the general populace. There is a clear demand from patients and healthcare providers for more information about the origins of tremor, and this research may provide the clarity they seek."
Exploring the Study's Objectives and Methodology
The aim of this expansive, three-year study is to ascertain if individuals diagnosed with ET exhibit P-SYN, a misfolded protein that potentially signals the early stages of PD. Essential tremor manifests as involuntary rhythmic shaking, typically observed in the hands, arms, legs, and head, adversely affecting the quality of life for many and contributing to disability. Statistically, this prevalent neurological condition affects more than five percent of those aged over 65, and it is linked with an increased probability of transitioning into Parkinson's disease.
Approximately 300 participants will take part in this important investigation, with recruitment expected to commence in the nearing months. The study will unfold across 15 sites throughout the U.S. under the expert supervision of three distinguished organizations: Baylor University Medical Center, University of Texas Southwestern Medical Center in Dallas, and Beth Israel Deaconess Medical Center in Boston, along with Drs. Joseph Jankovic, Elan Louis, and Ludy Shih leading the efforts.
Utilization of the Syn-One Test in Research
The research will implement the Syn-One Test, a diagnostic procedure involving a skin biopsy that yields vital pathological data to assist in evaluating individuals classified as 'at risk' for disorders associated with synucleinopathy, including Parkinson's disease. Utilizing an uncomplicated skin punch biopsy, researchers will measure the presence of P-SYN within the cutaneous nerve fibers of patients suffering from essential tremor.
Christopher Gibbons, MD, FAAN, chief scientific officer and co-founder of CND, emphasized the goals of this study: "Our objective is to establish that patients with essential tremor who receive positive results from the Syn-One Test possess a markedly higher probability of developing Parkinson's disease. Furthermore, we hope to illustrate that the accumulation rate of pathological alpha-synuclein is connected to the advancement of the disease. This knowledge will empower healthcare professionals with a deeper understanding of disease progression and better equip them with information to advise their patients regarding treatment options.”
Early Detection and Intervention as Primary Goals
Dr. Gibbons and his team also advocate for early identification as a critical step leading to timely interventions. As the medical community progresses toward creating groundbreaking therapies, it is essential for doctors to accomplish three pivotal actions: 1) detect the disease at its nascent stages, 2) initiate neuroprotective treatments promptly when they can be most effective, and 3) enhance focused monitoring and personalized care to ensure appropriate treatments are administered to each patient.
About CND Life Sciences
CND Life Sciences plays a crucial role in assisting patients facing the potential diagnosis of neurodegenerative conditions. With a CLIA-certified and CAP-accredited lab based in Scottsdale, Arizona, the company offers the Syn-One Test as a laboratory developed test (LDT) designed to help clinicians diagnose various synucleinopathies, including Parkinson’s disease. The Syn-One Test employs exclusive methods to detect phosphorylated alpha-synuclein in skin nerves while gauging other symptoms of peripheral nerve degeneration. Noteworthy findings from a prospective NIH-supported study about the Syn-One Test were recently published in the Journal of the American Medical Association (JAMA), demonstrating over 95% sensitivity in patients clinically diagnosed with specific synucleinopathies.
In addition to aiding in diagnostics, CND also collaborates with biopharmaceutical companies on clinical trials for new therapies and explores methods for early detection as well as synuclein quantification of neurodegenerative diseases.
Recognized as a Breakthrough Device by the U.S. Food and Drug Administration (FDA), the Syn-One Test is designed for the diagnosis of synucleinopathies in individuals aged 40 years and older who present clinical symptoms suggesting a synucleinopathy. The FDA’s Breakthrough Devices Program aims to accelerate the development and review process for medical devices that can provide more effective diagnoses and treatments for life-threatening conditions.
Frequently Asked Questions
What is the purpose of the NIH grant for CND Life Sciences?
The NIH grant will fund a study to assess whether the presence of the protein phosphorylated alpha-synuclein in essential tremor patients can predict the risk of developing Parkinson's disease.
How will the study be conducted?
The study will involve approximately 300 participants across 15 sites, utilizing the Syn-One Test through a straightforward skin biopsy procedure to monitor P-SYN levels.
Why is early detection important for Parkinson's disease?
Early detection can lead to timely interventions that may improve treatment effectiveness and patient outcomes, preserving quality of life.
What is the Syn-One Test?
The Syn-One Test is a diagnostic tool that analyzes skin biopsy samples to detect phosphorylated alpha-synuclein, aiding in the evaluation of synucleinopathies.
How does this research impact patients with essential tremor?
The research aims to provide clarity on the risks of developing Parkinson's disease, thus empowering patients and physicians with knowledge for better management of the condition.
